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Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

3802 Study Matches

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EAQ202: Improving Adolescent and Young Adult Self-Reported Data in ECOG-ACRIN Trials

Improving Adolescent and Young Adult Self-Reported Data in ECOG-ACRIN Trials

Zhaohui Jin
All
18 years to 39 years old
ERROR
This study is NOT accepting healthy volunteers
2022-307328-P01-RST
22-001776
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Inclusion Criteria:

  • Patient must be ≥ 18 years and ≤ 39 years of age at registration.
  • Patient must have a histologically confirmed diagnosis of primary cancer of any stage within 12 weeks (84 days) at registration.
  • Patient must have received, be currently receiving or planning to receive treatment for cancer, including surgery and/or chemotherapy and/or radiation therapy.
  • Patient must have an ECOG performance status 0-3.
  • Patient must have a life expectancy > 24 months.
  • Patient must be able to complete questionnaires in English.
  • Patient must have internet access through computer, tablet, or smartphone.
  • Patient must have an email address.
  • Patient must have a mobile phone able with text messaging capabilities.
  • Patient must be able to accurately provide self-report data (e.g., per clinical judgment, cognitive function is intact). Patient must be able to provide informed consent.


Exclusion Criteria:

  • Patient must not have a recurrence or second primary cancer.
  • Patient must not have basal cell skin carcinoma.

Eligibility last updated 2/17/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Remote State Representation in Early Psychosis (Rem-STEP)

All
18 Years to 45 Years old
Early Phase 1
This study is NOT accepting healthy volunteers
NCT05538832
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Inclusion Criteria:

• Diagnosis of one of the following conditions: Schizophrenia; Schizoaffective disorder; Schizophreniform disorder; Psychosis NOS; Major depressive disorder with psychotic features; or Bipolar disorder with psychotic features (confirmed with MINI 7.0 diagnostic interview)
• Between the ages of 18-45 at the time of screening
• Willing to share contact information for a clinical provider
• Fluent in spoken and written English, in that the participant learned to speak English before the age of 12 or is able to demonstrate fluency in conversation with study staff
• Has an outpatient status and no hospitalization for psychiatric reasons for at least 1 month prior to participant
• Has access to a computer with internet connection
• Has a United States address as permanent residence
Exclusion Criteria:

• History of severe substance use in the past 3 months (determined by the MINI 7.0 diagnostic criteria)
• Unable to demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in the research study
• Significant cognitive training experience within the last 6 months, as determined by the PI
• Diagnosed with a neurological disorder (Autism spectrum disorder is allowed)
Device: BrainHQ Computerized Cognitive Training - Visual Perception Training Paradigm, Device: BrainHQ Computerized Cognitive Training - Visual Cognitive Control Training Paradigm
Psychosis, Schizophrenia, Schizo Affective Disorder, Schizoaffective Disorder, Schizophreniform Disorders, Psychotic Disorders, Psychotic Mood Disorders, Psychoses, Affective, Psychosis Nos/Other, Schizophrenia Spectrum and Other Psychotic Disorders
Cognitive Training, Remote, Online, Clinical Trial
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University of Minnesota — Minneapolis, Minnesota Ariel Currie, MBS - (curri105@umn.edu)

Pilot Study of Circulating Cell Free Tumor DNA as a Biomarker in Sarcoma

A Study to Evaluate Circulating Cell Free Tumor DNA as a Biomarker in Sarcoma

Brittany Siontis
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122011-H01-RST
19-003215
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Inclusion Criteria:

  • Age 18 years old and older.
  • Advanced or metastatic bone or soft tissue sarcoma with a known translocation.
  • Evidence of disease progression or recurrence prior to initiation of systemic therapy.
  • No systemic therapy or major surgery within the past 30 days.
  • Willingness to provide blood and urine samples.
  • The absence of a second active malignancy.
  • An understanding of the protocol and its requirements, risks and discomforts.
  • Ability and willingness to sign an informed consent.

Exclusion Criteria

  • Pregnancy or lactation.
  • Inability to understand the informed consent.
Bone cancer, Cancer, Recurrent cancer, Sarcoma, Soft tissue sarcoma
Carrier of chromosome translocation, Medical Oncology, Musculoskeletal system, Sarcoma of soft tissue
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Mayo Clinic — Rochester, MN

ACCRU-GI-2008 - A Phase II Randomized Study of Atezolizumab Plus Multi-Kinase Inhibitor Versus Multi-Kinase Inhibitor Alone in Subjects With Unresectable, Advanced Hepatocellular Carcinoma Who Previously Received Atezolizumab Plus Bevacizumab (ACCRU-GI-2008)

Atezolizumab in Combination With a Multi-Kinase Inhibitor for the Treatment of Unresectable, Locally Advanced, or Metastatic Liver Cancer

Nguyen Tran
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2020-300519-P01-RST
22-000624
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Inclusion Criteria:

  • Provide written informed consent ≤ 28 days prior to randomization.
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
    • NOTE: During the Active Monitoring Phase of a study (i.e., active treatment and clinical follow-up), participants must be willing to return to the consenting institution for follow-up.
  • Age ≥ 18 years.
  • Hepatocellular carcinoma (HCC) confirmed by histological/cytological diagnosis or clinically per the American Association for the Study of Liver Diseases (AASLD) or WASL 2018 criteria -Locally advanced, metastatic and/or unresectable disease that is not amendable to curative treatment.
  • Previously progressed on atezolizumab in combination with bevacizumab as first line systemic therapy for advanced disease.
    • NOTE: 2nd line patients only.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
  • Child Pugh class A -Documented virology status of hepatitis, as confirmed by screening hepatitis B virus (HBV) and hepatitis C virus (HCV) serology tests.
  • For subjects with active HBV, HBV deoxyribonucleic acid (DNA) < 500 IU/mL obtained ≤ 28 days prior to randomization, and anti-HBV treatment (per local standard of care; e.g., entecavir) for a minimum of 14 days prior to randomization and willingness to continue treatment for the length of the study.
  • At least one measurable untreated malignant lesion per RECIST v1.1. Subjects who previously received local therapy (e.g., ablation, percutaneous ethanol injection, trans-arterial embolization/chemo-embolization) are eligible provided the target lesion(s) have not been previously treated with local therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with RECIST v1.1.
  • Consent to using archival tumor tissues, if available.
    • NOTE: Non-availability of tumor tissue does not exclude the subject.
  • Willingness to provide mandatory blood specimens for correlative research -Willingness to provide mandatory tissue specimens for correlative research for the first 10 patients per arm (Mayo Clinic Rochester and Mayo Clinic Arizona ONLY).
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (1500/uL) without granulocyte colony-stimulating factor support (obtained ≤ 28 days prior to randomization).
  • Lymphocyte count ≥ 0.5 x 10^9/L (500/uL) (obtained ≤ 28 days prior to randomization).
  • Platelet count ≥ 75 x 10^9/L (75,000/uL) (obtained ≤ 28 days prior to randomization).
  • Hemoglobin ≥ 90 g/L (9 g/dL) (obtained ≤ 28 days prior to randomization).
  • Subjects may be transfused to meet this criterion.
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 5 x upper limit of normal (ULN) (obtained ≤ 28 days prior to randomization).
  • Total bilirubin ≤ 3 x ULN (obtained ≤ 28 days prior to randomization).
  • Serum albumin ≥ 30 g/L (3.0 g/dL) (obtained ≤ 28 days prior to randomization).
  • For subjects not receiving therapeutic anticoagulation: international normalized ratio (INR) or partial thromboplastin time (aPTT) ≤ 1.5 × ULN (obtained ≤ 28 days prior to randomization).
  • Serum creatinine ≤ 2 x ULN or creatinine clearance ≥ 30 mL/min (calculated using the Cockcroft-Gault formula) (obtained ≤ 28 days prior to randomization).
  • Negative pregnancy test done ≤ 14 days prior to randomization, for women of childbearing potential only.
    • NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Resolution of any acute, clinically significant treatment-related toxicity from prior therapy to grade ≤ 1 prior to randomization, with the exception of alopecia and peripheral sensory neuropathy.
  • Subjects of childbearing potential agree to use two forms of medically approved contraception while taking the study drug and for at least 5 months after the last dose of atezolizumab or multi-kinase inhibitor. Subjects with partners of childbearing potential agree to use condoms, even after vasectomy, to avoid potential drug exposure to partner during study drug and for 5 months following the last dose of study drug.
  • Ability to take oral medications.


Exclusion Criteria:

  • Known diagnosis of fibrolamellar carcinoma, sarcomatoid carcinoma or mixed hepatocellular cholangiocarcinoma.
  • Prior multi-kinase inhibitor treatment for advanced disease (e.g., cabozantinib, lenvatinib, sorafenib, regorafenib).
    • NOTE: Use of multi-kinase inhibitor(s) for adjuvant or as part of loco-regional therapies is allowed as long as the therapy was completed ≥ 6 months prior to randomization.
  • Any of the following prior therapies:
    • Major surgery ≤ 4 weeks prior to randomization; Minor surgery ≤ 7 days prior to randomization (e.g., simple excision, tooth extraction, insertion of central lines/ Mediport). Subjects with clinically relevant complications from prior surgery are not eligible.
  • Any anti-cancer agent ≤ 2 weeks prior to randomization.
  • Radiation therapy ≤ 4 weeks (1 week for palliative radiation for bone metastases and/or for pain control) or radionuclide treatment (e.g., I-131 or Y-90) ≤ 6 weeks prior to randomization.
  • Treatment with investigational therapy ≤ 28 days prior to randomization.
  • Known brain or leptomeningeal metastasis.
  • Known co-infection of HBV and HCV. Subjects with a history of HCV infection but who are negative for HCV ribonucleic acid (RNA) by polymerase chain reaction (PCR) will be considered non-infected with HCV.
  • Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, or multiple sclerosis with the following exceptions:
    • Subjects with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.
  • Subjects with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
  • Subjects with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., subjects with psoriatic arthritis are excluded) are eligible for the study provided all of the following conditions are met:
    • Rash must cover < 10% of body surface area.
  • Disease is well controlled at baseline and requires only low-potency topical corticosteroids.
  • No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months.
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
    • NOTE: History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the subject at high risk from treatment complication.
  • Treatment with a live, attenuated vaccine ≤ 4 weeks prior to randomization, or anticipation of need for such a vaccine during atezolizumab treatment or ≤ 5 months after the last dose of atezolizumab.
  • History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.
  • Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation.
  • Subjects with untreated or incompletely treated esophageal/gastric varices with bleeding or high risk for bleeding. Subjects treated with adequate endoscopic therapy (according to local institutional standards) without any episodes of recurrent gastrointestinal bleeding requiring transfusion or hospitalization for > 28 days prior to randomization are eligible.
  • Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) ≤ 4 weeks or 5 drug elimination half-lives (whichever is longer) prior to randomization.
  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies.
    • NOTE: Prior treatment with atezolizumab is permitted.
  • Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF alpha agents) ≤ 2 weeks prior to randomization, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:
    • Subjects who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study.
  • Subjects who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible.
  • For subjects who are to receive cabozantinib: Treatment with strong inducers and/or strong inhibitors of CYP3A4 ≤ 14 days prior to randomization, including rifampin (and its analogues) or St. John's wort.
  • See https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interac tions-table-substrates-inhibitors-and-inducers for lists of known strong inhibitors and strong inducers of CYP3A4.
  • Active tuberculosis.
  • Other uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
    • Cardiovascular disorders including:
    • Symptomatic congestive heart failure, unstable angina, or serious cardiac arrythmias;
    • Uncontrolled hypertensions defined as sustained blood pressure (BP) > 150 mmHg systolic BP, or > 100 mmHg diastolic BP despite optimal antihypertensive treatment;
    • Stroke (including transient ischemic attack), myocardial infarction, or other ischemic event ≤ 3 months prior to randomization;
    • Unstable arrythmia;
    • Thromboembolic event ≤ 3 months prior to randomization.
  • Subjects with thromboses of portal/hepatic vasculature attributed to underlying liver disease and/or liver tumor are eligible.
  • Active bacterial infection requiring systemic treatment. Subjects on prophylactic antibiotics are eligible.
  • Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS) related illness. Subjects with known HIV but without clinical evidence of an immunocompromised state and receiving anti-retroviral therapy are eligible.
  • Prior allogenic stem cell or solid organ transplantation.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently).
  • Subjects with indwelling catheters (e.g., PleurX) are allowed.
  • Uncontrolled or symptomatic hypercalcemia (ionized calcium > 1.5 mmol/L, calcium > 12 mg/dL or corrected serum calcium > ULN).
  • Uncontrolled tumor-related pain.
  • Patients requiring pain medication must be on a stable regimen at the time of randomization.
  • Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to randomization. Patients should be recovered from the effects of radiation. There is no required minimum recovery period.
  • Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to randomization.
  • Other malignancy(ies) ≤ 5 years prior to randomization except adequately treated non-melanotic skin cancer, carcinoma-in-situ of the cervix, localized prostate cancer, ductal carcinoma in situ or stage I uterine cancer.
  • Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within at least 5 months after the last dose of study medication.
  • Uncontrolled hepatic encephalopathy occurring ≤ 6 weeks prior to randomization.
    • NOTE: Patients with ≤ grade 2 encephalopathy ≤ 6 weeks prior to randomization are eligible and supportive measures such as lactulose and antibiotics are allowed.

Eligibility last updated 8/8/22. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Drug
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Mayo Clinic — Rochester, MN

DP-1111-02CT: A Prospective, Randomised, Controlled, Open-label, Multicentre Study to Evaluate Efficacy, Safety and Patient-Reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Best Standard of Care in Patients With Well-differentiated Aggressive Grade 2 and Grade 3, Somatostatin Receptor-Positive (SSTR+), Neuroendocrine Tumours of GastroEnteric or Pancreatic Origin (COMPOSE)

Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE (COMPOSE)

Thorvardur Halfdanarson
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-305452-P01-RST
21-008020
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Inclusion Criteria:


- Patients aged ≥ 18 years.

- Histologically confirmed diagnosis of unresectable, well-differentiated
GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs). measurable site of disease
per RECIST v1.1 (Response evaluation criteria in solid tumors) using contrast computed
tomography (CT) / magnetic resonance imaging (MRI).

- Somatostatin receptor-positive (SSTR+) disease.


Exclusion Criteria:


- Known hypersensitivity to Lutetium 177Lu, edotreotide, DOTA (dodecane tetraacetic
acid), any of the comparators, or any excipient or derivative (e.g. rapamycin).

- Prior (Peptide Receptor Radionuclide Therapy) PRRT.

- Any major surgery within 4 weeks prior to randomization in the trial.

- Therapy with an investigational compound and/or medical device within 30 days or 7
half-life periods (whichever is longer) prior to randomization.

- Other known malignancies.

- Serious non-malignant disease.

- Renal, hepatic, cardiovascular, or hematological organ dysfunction, potentially
interfering with the safety of the trial treatments.

- Pregnant or breastfeeding women.

- Patients not able to declare meaningful informed consent on their own or any other
vulnerable population to that.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 12/13/22. Questions regarding updates should be directed to the study team contact.

Drug, Other
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Mayo Clinic — Rochester, MN

Screening for High Frequency Malignant Disease (SHIELD) (SHIELD)

Screening for High Frequency Malignant Disease

David Midthun
All
50 years to 80 years old
This study is NOT accepting healthy volunteers
2021-306760-P01-RST
22-000772
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Inclusion Criteria:

  • Subject aged 50-80 years at time of consent.
  • Increased risk of lung cancer defined by having at least 20 pack-year smoking history and currently smoke or have quit within the past 15 years.
  • Undergoing or intended to undergo low dose CT scan of the chest for lung cancer screening.
  • Willing to consent to the investigational blood draw during index low dose CT scan screening visit and before any invasive procedures or treatment for lung cancer diagnosis.
  • Willing to consent to a 1-year, 2-year and additional follow-up per protocol.


Exclusion Criteria:

  • Subject has not smoked for 15 or more years.
  • Subject has less than 20 pack-year smoking history.
  • Subject has a health problem that substantially limits life expectancy and/or the ability or willingness to have curative lung surgery.
  • Subject undergoing low-dose CT scan of the chest for investigation of symptoms suspicious for lung cancer.
  • Preexisting or history of lung cancer.
  • Previously diagnosed high-risk lung lesion.
  • History of any malignancy (subjects who have undergone surgical removal of skin squamous cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of provision of informed consent for the study).
  • Currently taking any anti-neoplastic or disease-modifying anti-rheumatic drugs.
  • Currently receiving treatment for pneumonia.
  • Any major physical trauma (e.g., disruption of tissue, surgery, organ transplant, blood product transfusion) within the 30 days leading up to the provision of informed consent.
  • Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
  • Participation in a clinical research study in which an experimental medication and/or medical procedure has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of subject screening.
  • Additional cohorts: inclusion and exclusion criteria will be specified for each cohort as appendixes.

Eligibility last updated 1/21/22. Questions regarding updates should be directed to the study team contact.

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A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants With Advanced Cancer

First in Human Study of TORL-1-23 in Participants With Advanced Cancer

Andrea Wahner Hendrickson
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2022-306904-P01-RST
22-000456
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Inclusion Criteria:


- Advanced solid tumor

- Measurable disease, per RECIST v1.1

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- Adequate organ function


Exclusion Criteria:


- Has not recovered [recovery is defined as NCI CTCAE, version 5.0, grade ≤1] from the
acute toxicities of previous therapy, except treatment-related alopecia or laboratory
abnormalities otherwise meeting eligibility requirements

- Received prior chemotherapeutic, investigational, or other therapies for the treatment
of cancer within 14 days with small molecule and within 28 days with biologic before
the first dose of TORL-1-23

- Progressive or symptomatic brain metastases

- Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active,
uncontrolled infection

- History of significant cardiac disease


- History of myelodysplastic syndrome (MDS) or AML

- History of another cancer within 3 years before Day 1 of study treatment, with the
exception of basal or squamous cell carcinoma of the skin that has been definitively
treated. A history of other malignancies with a low risk of recurrence, including
appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate
cancer with a Gleason score less than or equal to 6, are also not excluded

- If female, is pregnant or breastfeeding

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 8/23/22. Questions regarding updates should be directed to the study team contact.

Drug
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Mayo Clinic — Rochester, MN

CASCADE-LUNG: Cancer Screening Assay Using DELFI; A Clinical Validation Study in Lung (DELFI-L201)

CASCADE-LUNG: Cancer Screening Assay Using DELFI; A Clinical Validation Study in Lung (DELFI-L201)

David Midthun
All
50 years and over
This study is NOT accepting healthy volunteers
2022-307659-P01-RST
22-003100
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Inclusion Criteria:


- All subjects

1. Ability to understand and provide written informed consent

2. Age ≥ 50 years

3. Current or former smoker

4. ≥ 20 pack-years (pack years = number of packs per day × number of years smoked)

5. An initial or annual follow-up lung cancer screening chest CT planned/scheduled
within 30 days after enrollment (i.e., enrollment chest CT scan)


Exclusion Criteria:


- All subjects

1. Evidence of any diagnosed cancer (including prior lung cancer) other than
non-melanoma skin cancer or carcinoma in situ within 2 years prior to enrollment

2. Prior systemic therapy, definitive therapy, radiation, or surgical resection for
any cancer diagnosis within 2 years prior to enrollment (with the exception of
surgery for nonmelanoma skin cancer and biopsies)

3. Any history of hematologic malignancy or myelodysplasia within 2 years prior to
enrollment

4. Any history of organ tissue transplantation

5. Any history of blood product transfusion within 120 days prior to enrollment

6. Current pregnancy

7. Any condition that in the opinion of the Investigator should preclude the
participant's participation in the study

8. Past or current participation in any clinical study sponsored by Delfi
Diagnostics or any history of a LDT (Laboratory Developed Test) for early
detection of lung cancer by Delfi Diagnostics

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 4/10/23. Questions regarding updates should be directed to the study team contact.

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Mobile Application Based Lactulose Titration for Prevention of Hepatic Encephalopathy

Prevention of Hepatic Encephalopathy With Mobile Application Based Lactulose Titration

Douglas Simonetto
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-308598-H01-RST
22-006646
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Inclusion Criteria:

  • Patients over the age of 18 years.
  • Ability to provide written, informed consent.
  • Currently taking lactulose daily for prevention of hepatic encephalopathy.

Exclusion Criteria:

  • Recent change in dosing of opioid medication.
  • Previous Colorectal Surgery.
  • Active diarrheal illness.
  • Lack of smartphone or other smart device at home.

Eligibility last updated 7/8/22. Questions regarding updates should be directed to the study team contact.

 

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A Phase II Prospective Study Evaluating the Role of Daratumumab in HLA Desensitization Prior to Transplantation

Daratumumab in Cardiac HLA Desensitization Prior to Transplantation

Barry Boilson
All
18 years to 80 years old
Phase 2
This study is NOT accepting healthy volunteers
2020-303075-H01-RST
20-012885
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General

Inclusion Criteria:


- Absolute neutrophil count > 1,500

- Total bilirubin < 1.5 x institutional upper limit normal (ULN)

- AST/ALT < 2. 5
•3x ULN (Options for patients with liver dysfunction may be available)

- Creatinine clearance > 20 ml/min

Specific Inclusion Criteria [HLA Desensitization Group]:

- Calculated PRA (cPRA) greater than 50%.

- Currently, or under consideration to be, actively listed for heart or combined heart and kidney transplantation.

- Negative pregnancy test (if woman of childbearing potential) If able to become pregnant or father a child, agreement to use one of the birth control methods
described in this protocol

- Able to provide informed consent

General
Exclusion Criteria:


- Prior or current exposure to any of the following: daratumumab or other anti-CD-38 therapies, exposure to an investigational drug (including investigational vaccine) or
invasive investigational medical device for any indication within 4 weeks or 5 pharmacokinetic half-lives, whichever is longer.

- Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) < 50% of predicted normal. Note that FEV1 testing is required for
participants suspected of having COPD and participants must be excluded if FEV1 is < 50% of predicted normal.

- Moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification. Note that participants who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate.

- Woman who is pregnant or breastfeeding. Participant is: known history of human immunodeficiency virus (HIV); Seropositive for hepatitis B (defined by a positive test
for hepatitis B surface antigen [HBsAg]). Subjects with resolved infection (i.e., subjects who are HBsAg negative with antibodies to total hepatitis B core antigen
[anti-HBc] with or without the presence of hepatitis B surface antibody [anti-HBs]) must be screed using real-time polymerase chain reaction (PCR) measurement of
hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded.

EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of HBV vaccination, do
not need to be testing for HBV DNA by PCR; Seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks
after completion of antiviral therapy).

Clinically significant cardiac disease, including: myocardial infarction within 6 months before randomization, or unstable or uncontrolled disease/condition related to or affection
cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III-IV); Uncontrolled cardiac arrhythmia


Specific Exclusion Criteria [HLA Desensitization Group]:

- Patients listed for combined heart and liver transplantation will be excluded, as our unique experience with combined heart liver transplant (liver placed first), has demonstrated that in those cases high levels of circulating HLA antibodies may not increase the risk of hyperacute rejection.

- Seropositivity for human immunodeficiency virus (HIV)

- Seropositivity for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Subjects with resolved infection (ie, subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or
antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels.
Those who are PCR positive will be excluded.

EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic
marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR.

- Seropositivity for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy).

- Patients unable to give informed consent will also be excluded.

Biologic/Vaccine, Desensitization therapy
Transplant disorder
Heart transplant, Hyperacute graft rejection
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TRAjectories and Clinical ExpeRiences of ICD Therapy (TRACER-ICD) Study (TRACER-ICD)

TRAjectories and Clinical ExpeRiences of ICD Therapy (TRACER-ICD) Study

Peter Noseworthy
All
65 years and over
This study is NOT accepting healthy volunteers
2021-304722-P01-RST
21-005174
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Inclusion Criteria:

  • Patient receiving new primary prevention ICD (excluding cardiac resynchronization therapy).
  • Age ≥ 65 years.
  • English-speaking (assessment instruments are only available/validated in English).
  • Sufficient cognitive ability to provide consent (i.e., answer simple questions on study participation, purpose and procedures).


Exclusion Criteria:

  • Individuals < 65 years.
  • Non-English speaking.
  • Inability to provide consent.
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Vitamin D-Sulfates in Breastmilk

Study of Breastmilk With Vitamin D-Sulfates

Thomas Thacher
Female
1 months to 60 years old
This study is NOT accepting healthy volunteers
2022-308273-H01-RST
22-005324
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Inclusion Criteria:

  • Lactating women.
  • ≥ 2 weeks after delivery.
  • No intentions of weaning during the study.


Exclusion Criteria:
 

  • History of sarcoidosis.
  • History of renal disease.
  • Premature birth.
  • Taking daily supplement with ≥ 600 IU vitamin D in the past 30 days (accounting for washout period).
Finding of lactation, Infant diet
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Safety and Efficacy Study of Retifanlimab and Epacadostat in Combination With Radiation and Bevacizumab in Patients With Recurrent Gliomas

Retifanlimab and Epacadostat in Combination With Radiation and Bevacizumab in Patients With Recurrent Gliomas

Sani Kizilbash
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2020-301945-P01-RST
20-008917
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Inclusion Criteria:


- Recurrent WHO grade 4 glioblastoma or gliosarcoma, including molecular features of glioblastoma and WHO grade 4 astrocytoma or WHO grade high grade glioma.

- Other GBM variants and "secondary GBM" are allowed. All grade 4 gliomas that have relapsed more than once may be included, as the prognosis of multiply recurrent grade
4 glioma patients may not differ based on IDH mutation status.

- Disease must have recurred, and patient must be a candidate for re-irradiation and bevacizumab. Any number of recurrences are allowed.

- Patients must have measurable disease per RANO criteria. Lesions will be considered measurable when they are bi-dimensional with clearly defined margins of ≥5 mm in two
perpendicular diameters.

- Prior transient use of bevacizumab for cerebral edema or radiation necrosis is allowed without a washout period. Prior bevacizumab use is permitted if used for treatment of
disease if administered more than 4 months prior to registration.

- At least 18 years of age.

- Karnofsky performance status ≥ 60%.

- Normal bone marrow and organ function as defined below:

- Absolute neutrophil count ≥ 1,000/mcL;

- Platelets ≥ 75,000/mcL;

- Hemoglobin ≥ 9.0 g/dL or > 5.6 mmol/L (transfusion is acceptable to meet this ;criterion)

- Serum creatinine ≤ ULN or creatinine clearance ≥ 60 mL/min/1.73 m^2 by Cockcroft-Gault for patients;

- Serum total bilirubin ≤ 1.5 ULN;

- AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN;

- INR or PT ≤ 1.5 x IULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants;

- aPTT ≤ 1.5 x IULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.

- At least 28 days from any major surgery such as craniotomy and surgical wound is fully healed, and at least 14 days from LITT or biopsy. Prior to surgery, there must be imaging evidence of measurable progressive disease (PD) per RANO criteria as noted above.

- Women of childbearing potential and men must agree to use highly effective contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.

- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

- Prior use of the Optune device is allowed, without a washout period. However, concurrent Optune use is not permitted while on treatment for this trial.


Exclusion Criteria:


- Currently receiving any other investigational agents.

- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to epacadostat, retifanlimab, bevacizumab, or other agents used in the study.

- Dexamethasone dose > 4 mg daily at the time of registration (higher dose of steroid for symptom control is allowed during the study).

- History of intracranial abscess within 6 months prior to start of study therapy.

- Has active autoimmune disease or syndrome (i.e. moderate or severe rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, active inflammatory bowel disease) that has required systemic treatment in the past 2 years (i.e. with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) or who are receiving systemic therapy for an autoimmune or inflammatory disease (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Subjects are permitted to enroll if they have vitiligo, resolved childhood
asthma/atopy, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.

- Has a severe acute or chronic medical condition including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis, or psychiatric conditions
including recent (within the past year) or active suicidal ideation or behavior, or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the
interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

- Has had an allogeneic tissue/solid organ transplant.

- Has an active infection requiring intravenous antibiotic therapy. Has a known history of active tuberculosis (TB; bacillus tuberculosis).

- Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, or IDO inhibitor.

- If a patient is enrolled to regimen B, they are prohibited from receiving monoamine oxidase inhibitors (MAOIs) or drug which has significant MAOI activity (meperidine, linezolid, methylene blue) within the 21 days before screening.

- If a patient is enrolled to regimen B, the use of any UGT1A9 inhibitor from screening through follow-up period, including acitretin, amitriptyline, androsterone, cyclosporine, dasatinib, diclofenac, diflunisal, efavirenz, erlotinib, estradiol
(17-beta), flutamide, gefitinib, gemfibrozil, glycyrrhetinic acid, glycyrrhizin, imatinib, imipramine, ketoconazole, linoleic acid supplements, mefenamic acid, mycophenolic acid, niflumic acid, nilotinib, phenobarbital, phenylbutazone, phenytoin,
probenecid, propofol, quinidine, ritonavir, sorafenib, sulfinpyrazone, valproic acid, and verapamil is prohibited.

- If a patient is enrolled to regimen B, the use of probiotics from screening through end of treatment is prohibited.

- If a patient is enrolled to regimen B, the use of warfarin is prohibited. If anti-coagulation is needed during the conduct of the study and non-warfarin regimens are not feasible, the participant must discontinue study therapy.

- Chronic use of systemic antibiotics (> 14 days) unless medical monitor review and approval.

- Any history of serotonin syndrome (SS) after receiving serotonergic drugs.

- Has uncontrolled HIV (HIV 1/2 antibodies). Well-controlled HIV is defined as CD4+ count > 300 cells, undetectable viral load, and receiving HAART/ART. Study specific HIV testing is not required for patients who do not have any prior history of HIV.

- Has uncontrolled active hepatitis B (e.g., HBsAg reactive or HBV DNA detected by quant RT PCR) or hepatitis C (e.g., HCsAg reactive or HCV RNA [qualitative or quantitative]
is detected).

- Uncontrolled intercurrent illness including, but not limited to, clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 60 months prior to
enrollment), congestive heart failure (≥ NYHA class II), unstable angina pectoris, or serious cardiac arrhythmia requiring medication.

- History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful. Screening QTc interval > 480 msec will require
investigator's evaluation on patient's eligibility. Subjects with left bundle branch block are excluded.

- Presence of a gastrointestinal condition that may affect drug absorption.

- Receipt of live attenuated vaccine within 30 days before the first dose of study treatment. Examples of live vaccines include, but are not limited to, the following:
measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally
killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed.

- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test prior to the start of study treatment.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 8/30/22. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Drug, Procedure/Surgery, Radiation
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Evaluation of Cardiac Surgical Technical Skills & Operating Team Non-Technical Practices Through Digital Recordings to Advance Cardiac Surgical Outcomes

Evaluation of Cardiac Surgical Technical Skills & Operating Team Non-Technical Practices Through Digital Recordings to Advance Cardiac Surgical Outcomes

John Stulak
All
18 years and over
This study is NOT accepting healthy volunteers
2021-304743-P01-RST
21-005235
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Inclusion Criteria:

  • Patients 18 years of age and older.
  • Undergoing a cardiac surgery at participating centers.
  • Intraoperative team members involved in cardiac surgery at participating centers.


Exclusion Criteria:

  • Individuals under 18 years of age.
     
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Measuring Cell Free DNA During the Course of Treatment for Esophageal Cancer as a Marker of Response and Recurrence with Natera (cfDNA with Natera)

cfDNA with Natera

Shanda Blackmon
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307127-P01-RST
22-001607
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Inclusion Criteria:

  • Esophageal cancer any stage.
  • Age ≥ 18 years old.
  • Willing and able to provide consent.
  • No prior history of neoadjuvant therapy for the esophageal cancer.


Exclusion Criteria:
 

  • Age < 18 years old.
  • Unable to provide consent.

Eligibility last updated 2/11/22. Questions regarding updates should be directed to the study team contact.

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A Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis (HZN825)

A Trial to Evaluate the Effectiveness, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis

Ashima Makol
All
18 years to 75 years old
Phase 2/3
This study is NOT accepting healthy volunteers
2021-304251-P01-RST
21-009225
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Inclusion Criteria:

  • Written informed consent.
  • Male or female between the ages of 18 and 75 years, inclusive, at Screening.
  • Meets the 2013 American College of Rheumatology/European League Against Rheumatism classification criteria for SSc with a total score of ≥ 9 (Van den Hoogen et al., 2013).
  • Classified as having skin involvement proximal to the elbow and knee (diffuse cutaneous SSc subset by LeRoy and Medsger, 2001).
  • At the time of enrollment, less than 36 months since the onset of the first SSc manifestation, other than Raynaud's phenomenon.
  • Based on data available through medical history and/or medical records, the subject should have at least 1 of the following:
    • disease duration ≤ 18 months;
    • increase ≥ 3 in mRSS units compared with the last visit within the previous 1 month to 6 months;
    • involvement of 1 new body area with ≥ 2 mRSS units or 2 new body areas with ≥1 mRSS unit;
    • documentation of worsening skin thickening for subjects who did not have mRSS performed during the previous visit;
    • presence of tendon friction rub at Screening.
  • Presence of at least 1 of the following features of elevated acute phase reactants at Screening:
    • high-sensitivity C-reactive protein (hsCRP) ≥0.6 mg/dL (≥ 6 mg/L);
    • erythrocyte sedimentation rate (ESR) ≥ 28 mm/hr;
    • platelet count ≥ 330 × 10^9/L (330,000/μL).
  • Skin thickening from SSc in the forearm suitable for repeat biopsy.
  • mRSS units ≥ 15 at Screening.
  • FVC ≥ 45% predicted at Screening, as determined by spirometry.
  • Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.


Exclusion Criteria:

  • Positive for anti-centromere antibodies.
  • Diagnosed with sine scleroderma or limited cutaneous SSc.
  • Diagnosed with other autoimmune connective tissue diseases, except for fibromyalgia, scleroderma-associated myopathy and secondary Sjogren's syndrome.
  • Scleroderma renal crisis diagnosed within 6 months of the Screening Visit.
  • Any of the following cardiovascular diseases:
    • uncontrolled, severe hypertension (≥ 160/100 mmHg) or persistent low blood pressure (systolic blood pressure < 90 mmHg) within 6 months of Screening,
    •  myocardial infarction within 6 months of Screening,
    •  unstable cardiac angina within 6 months of Screening.
  • DLCO < 40% predicted (corrected for hemoglobin). If severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) exposure is of clinical concern for any subject, consider using a DLCO up to 6 months before the Screening Visit.
  • Pulmonary arterial hypertension (PAH) by right heart catheterization requiring treatment with more than 1 oral PAH-approved therapy or any parenteral therapy. Treatment is allowed for erectile dysfunction and/or Raynaud's phenomenon/digital ulcers.
  • Corticosteroid use for conditions other than SSc within 4 weeks prior to Screening (topical steroids for dermatological conditions and inhaled/intranasal/intra-articular steroids are allowed).
  • Use of any other non-steroid immunosuppressive agent, small biologic molecule, cytotoxic or anti-fibrotic drug within 4 weeks of Screening, including cyclophosphamide, azathioprine (Imuran®) or other immunosuppressive or cytotoxic medication. Exceptions include mycophenolate mofetil (CellCept®), mycophenolic acid (Myfortic®), methotrexate and low-dose prednisone, as follows: use of CellCept ≤ 3 g/day, Myfortic ≤ 2.14 g/day, methotrexate ≤ 15 mg/week and prednisone ≤ 10 mg/day (or equivalent dosing of glucocorticoids) is allowed. Subjects taking CellCept, Myfortic or methotrexate must have been doing so for ≥ 6 months and the dose must have been stable for ≥ 16 weeks prior to the Day 1 Visit. Prednisone must have been at a stable dose for ≥ 8 weeks prior to the Day 1 Visit. It is acceptable to be on background low-dose prednisone and anti-malarial drug along with CellCept, Myfortic or methotrexate. Rituximab must not have been used within 6 months of the Day 1 Visit.
  • Known active bacterial, viral, fungal, mycobacterial or other infection, including tuberculosis or atypical mycobacterial disease (fungal infections of nail beds are allowed).
  • Use of a United States Food and Drug Administration-approved agent for SSc or an investigational agent for any condition within 90 days or 5 half-lives, whichever is longer, prior to Screening or anticipated use during the course of the trial. 12. Malignant condition in the past 5 years (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ).
  •  Women of childbearing potential or male subjects not agreeing to use highly effective method(s) of birth control throughout the trial and for 1 month after last dose of trial drug. Male subjects must refrain from sperm donation and females from egg/ova donation for this same time period.
  • Pregnant or lactating women.
  • Current drug or alcohol abuse or history of either within the previous 2 years, in the opinion of the Investigator or as reported by the subject.
  • Previous enrollment in this trial or participation in a prior HZN-825 or SAR100842 clinical trial.
  • Known history of positive test for human immunodeficiency virus.
  • Active hepatitis (hepatitis B: positive hepatitis B surface antigen and positive anti-hepatitis B core antibody [anti-HBcAb] and negative hepatitis B surface antibody [HBsAb] or positive for HBcAb with a positive test for HBsAb and with presence of hepatitis B virus DNA at Screening; hepatitis C: positive anti-hepatitis C virus [anti-HCV] and positive RNA HCV).
  • Current alcoholic liver disease, primary biliary cirrhosis or primary sclerosing cholangitis.
  • Previous organ transplant (including allogeneic and autologous marrow transplant).
  • International normalized ratio > 2, prolonged prothrombin time > 1.5 × the upper limit of normal (ULN) or partial thromboplastin time > 1.5 × ULN at Screening.
  • Alanine aminotransferase or aspartate aminotransferase > 2 × ULN.
  • Estimated glomerular filtration rate < 30 mL/min/1.73 m^2 at Screening.
  • Total bilirubin > 2 × ULN. Subjects with documented diagnosis of Gilbert's syndrome may be enrolled if their total bilirubin is ≤ 3.0 mg/dL.
  • Any other condition that, in the opinion of the Investigator, would preclude enrollment in the trial.
Drug, Other
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CAN-2409 Plus Prodrug With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC Patients

GMCI Plus Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC

Janani Reisenauer
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-304312-P01-RST
21-005087
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Inclusion Criteria:


1. Patients with Stage III/IV NSCLC on first line treatment with anti-PD-1/PD-L1 (ICI)
+/- chemotherapy for their current stage of disease and fits into one of the following
cohorts as determined by investigator, preferably as per RECIST 1.1: Cohort 1) have
persistent but stable disease at least 18 weeks after starting ICI treatment, or
Cohort 2) have radiographic progressive disease at least 18 weeks after starting ICI
treatment

2. RECIST evaluable disease including a lesion that is amenable to injection

3. Able and willing to undergo a pre-treatment and on-treatment biopsies, if feasible

4. ECOG Performance status of 0 or 1

5. 18 years of age or older

6. Granulocyte count (ANC) ≥ 1,000/mm3

7. Hemoglobin ≥ 8 g/dl (patients may be transfused to meet this criterion)

8. Platelets ≥ 75,000/mm3

9. Total bilirubin ≤ 1.5 x upper limit of normal, except for patients with known Gilbert
disease who must have total bilirubin ≤ 3 x upper limit of normal

10. SGOT (AST) ≤ 5x upper limit of normal and if elevated, not clinically significant such
that ICI can continue

11. INR no more than 0.2 above upper limit of normal and aPTT not >1.2 x upper limit of
normal, and value is acceptable for patient to undergo injection procedure. If on
anti-coagulation, it must be clinically acceptable to hold anti-coagulation for the
injection procedures per investigator discretion

12. Serum creatinine < 2mg/dl and calculated creatinine clearance > 30ml/min

13. Clinically stable and able to continue ICI for at least the 12-week treatment period

14. Within 6 months of enrollment, no change of ICI therapy or prior interruptions of more
than 4 weeks of current ICI

15. Patients should not have received focal therapy (e.g., radiotherapy) at more than
three different sites of disease within 12-months prior to enrollment

16. Patients must give study specific informed consent prior to enrollment and any study
specific procedures


Exclusion Criteria:


1. Patients with a history of severe immune related adverse events related to ICI

2. Patients who require ongoing therapy with disease-modifying antirheumatic drugs
(DMARDs), immunomodulators or systemic immunosuppressive drugs including systemic
corticosteroids (>10 mg prednisone per day or equivalent)
•premedication for ICI or
chemotherapy is allowed

3. Patients with a history of active autoimmune disease requiring treatment in the past 2
years

4. Patients with uncontrolled intercurrent illness including, but not limited to, ongoing
or active infection, symptomatic congestive heart failure, unstable angina pectoris,
cardiac arrhythmia, active hepatitis, or psychiatric illness/social situations that
would limit compliance with study requirements

5. Women who are pregnant, lactating or intend to become pregnant during the study

6. Patients who are known to be HIV positive

7. Patients with a history of hypersensitivity or allergic reactions to valacyclovir or
acyclovir

8. Patients with significant heart disease (New York Heart Association Functional
Classification III or IV)

9. Patients with continuous oxygen dependence >2L/min at rest

10. Tumor impinging on a neurovascular structure such that inflammation in the site may
put patient at risk of compromise as determined by the investigator

11. Patients with uncontrolled brain metastases as per investigator

12. Patients with liver metastases involving more than half of the liver

13. Patients with known EGFR mutation, ALK fusion, or ROS1 fusion positive NSCLC, or that
are receiving tyrosine kinase inhibitor (TKI) agents/ALK/ROS1 inhibitors

14. Patients with known interstitial lung diseases (ILDs) requiring active therapy
(Radiographic fibrosis not requiring therapy is allowed)

15. Patients receiving vascular endothelial growth factor (VEGF) inhibitors (including
bevacizumab, ramucirumab) within the past 2 months or five half-lives, whichever is
longer

16. Patients must have no concurrent malignancy requiring treatment (except squamous or
basal cell skin cancers)

17. Patients without contrast enhanced imaging at baseline or those with contraindication
to the use of contrast.

18. Patients who are pregnant, breastfeeding, or plan to become pregnant.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 7/18/23. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Drug, Procedure/Surgery
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2020-0641, Pembrolizumab in Combination with Dabrafenib and Trametinib as a Neoadjuvant Strategy Prior to Surgery in BRAF-mutated Anaplastic Thyroid Cancer

Pembrolizumab, Dabrafenib, and Trametinib Before Surgery for the Treatment of BRAF-Mutated Anaplastic Thyroid Cancer

Mabel Ryder
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-306042-P01-RST
21-010193
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Inclusion Criteria:

  • Pathologic findings supporting the clinical impression of anaplastic thyroid  carcinoma. Diagnosis may include consistent with or suggestive of terminology  associated with: anaplastic thyroid carcinoma, undifferentiated carcinoma, squamous  carcinoma; carcinoma with spindled, giant cell, or epithelial features; poorly differentiated carcinoma with pleomorphism, extensive necrosis with tumor cells present.
  • Must have a BRAFV600E mutation-positive tumor, as determined by BRAF V600E  immunohistochemistry on tumor tissue, genetic/molecular testing of tumor, or cell free  (cf)NDA liquid biopsy.
  • Have measurable disease based on RECIST 1.1.
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN). Total bilirubin ≤ 3 x ULN for  patients with Gilbert's syndrome.
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase  [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])  ≤ 2.5 x ULN, (5 x ULN for patients with concurrent liver metastases).
  • Serum creatinine ≤ within 1.5 x ULN.
  • Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L.
  • Platelets ≥ 100 x 10^9/L.
  • Hemoglobin ≥ 9.0 g/dL or 5.6 mmol/L.
  • International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN unless  participant is receiving anticoagulant therapy as long as PT or activated partial  thromboplastin time (aPTT) is within therapeutic range of intended use of  anticoagulant.
  • Subjects must be willing to undergo tumor biopsy prior to and after the run-in with dabrafenib/trametinib (DT), unless in the opinion of the treating physician, a biopsy is not feasible or safe. Subjects must be willing to ultimately undergo surgery if  their tumor becomes surgically resectable. Research subjects retain the right to  refuse any research interventions.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.  Evaluation of ECOG is to be performed within 7 days prior to the date of allocation/randomization.
  • The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
  • A male participant must agree to use a contraception of this protocol during the  treatment period and for at least 8 months after the last dose of study treatment and  refrain from donating sperm during this period.
  • A female participant is eligible to participate if she is not pregnant, not  breastfeeding, and at least one of the following conditions applies:  
    • Not a woman of childbearing potential (WOCBP); OR
    • A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 6 months after the last dose of study treatment.


Exclusion Criteria:
 

  • Significant cardiovascular impairment: history of congestive heart failure greater  than New York Heart Association (NYHA) class II.
  • Untreated brain metastases.
  • Prior chemotherapy within < 1 week prior to study day 1 or patients who have not  recovered (i.e., ≤ grade 2) from adverse events due to a previously administered  agent, except for patients who have been on dabrafenib/trametinib (DT) according to  the standard run-in outlined in the trial schema.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years  (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid  replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • History of human immunodeficiency virus (HIV) or active hepatitis B (chronic or acute)  or hepatitis C infection. Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive  anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible. However,  patients with past or resolved hepatitis B virus (HBV) should be monitored for  reactivation by a specialist. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic  acid (RNA).
    • Note: no testing for HIV, hepatitis B and hepatitis C is required unless  mandated by local heath authority.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
  • Has received a live or live-attenuated vaccine within 30 days prior to the first dose  of study drug. Administration of killed vaccines is allowed.
  • Has severe hypersensitivity (≥ grade 3) to pembrolizumab and/or any of its excipients.
  • Has a history of (non-infectious) pneumonitis/interstitial lung disease that required  steroids or has current pneumonitis/interstitial lung disease.
  • Has known psychiatric or substance abuse disorders that would interfere with  cooperation with the requirements of the trial.
  • Females who are breastfeeding or pregnant at screening or baseline (as documented by a positive beta-human chorionic gonadotropin [beta-hCG] (or human chorionic gonadotropin  [hCG]) test with a minimum sensitivity of 25 IU/L or equivalent units of beta-hCG [or hCG]). A women of childbirth potential (WOCBP) who has a positive urine pregnancy test within 72 hours prior to the first infusion will be excluded. If the urine test is  positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • More than 30 days of DT therapy prior to enrollment.
  • A known history of retinal vein occlusion (RVO), central serous retinopathy (CSR), uncontrolled glaucoma or ocular hypertension.

Eligibility last updated 9/27/21. Questions regarding updates should be directed to the study team contact.

 

Drug, Procedure/Surgery, Radiation, Other
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A Phase 2 Study of Donor-Derived Multi-Tumor-Associated Antigen-Specific T Cells (MT-401) Administered to Patients with Acute Myeloid Leukemia (AML) following Hematopoietic Stem Cell Transplantation (ARTEMIS) (MRKR-19-401-01)

AML: Treatment of Relapse after Transplant or Extended Maintenance of Remission – Investigational Study (ARTEMIS) Effectiveness of MT-401 in Patients with AML Following Stem Cell Transplant

Mithun Shah
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-305430-P01-RST
21-007911
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Inclusion Criteria

1. First allogeneic HSCT, in ≤ CR2, and MRD negative prior to transplant (including
matched sibling, MUD with at least 6 of 8 HLA markers, or haploidentical with at least
5 of 10 HLA markers) as:

- Adjuvant therapy for AML (Group 1) at 90 days (±10 days) post-HSCT defined as
patients with CRMRD; or

- Treatment for refractory/relapsed AML (first relapse post-HSCT) when disease
occurs after transplant (Group 2) defined as

- First relapse (MRD+ or frank relapse) post-HSCT

- Patients in Arm 1B (SOC) who experience first relapse (MRD+ or frank
relapse) post HSCT

- Safety Lead-in defined as patients who fit all the criteria for Group 2 only

2. Are ≥18 years of age

3. Karnofsky/Lansky score of ≥60

4. Life expectancy ≥12 weeks

5. Adequate blood, liver, and renal function

- Blood: Hemoglobin ≥7.0 g/dL (can be transfused)

- Liver: Bilirubin ≤2X upper limit of normal; aspartate aminotransferase ≤3X upper
limit of normal

- Renal: Serum creatinine ≤2X upper limit of normal or measured or calculated
creatinine clearance ≥45mL/min

7. Patients are allowed to be on experimental conditioning regimens prior to transplant if
no planned maintenance therapy post-transplant.

8. In Group 2, patients may receive bridging therapy at the investigators' discretion in
situations where MT-401 is not ready for administration or the treating physician believes
the patient would benefit

Exclusion Criteria

1. Clinically significant or severely symptomatic intercurrent infection

2. Pregnant or lactating

3. For Group 1, anti-neoplastic therapy after HSCT and prior to or during dosing of
MT-401

4. For Group 2, concomitant anti-neoplastic therapy during or after dosing of MT-401

5. Evidence of acute or chronic GVHD ≥Grade 2 (exception: acute or chronic Grade 2 GVHD
of skin allowed if stable) within one week prior to receiving MT-401

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 12/27/22. Questions regarding updates should be directed to the study team contact.

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MC210811, REsponse Adapted Combination Therapy Approaches for High-Risk Multiple Myeloma (REACH) (REACH)

Response Adapted Combination Therapy Approaches for High-Risk Multiple Myeloma

Shaji Kumar
All
18 years to 80 years old
Phase 2
This study is NOT accepting healthy volunteers
2021-306286-P01-RST
22-002687
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Inclusion Criteria:

  • Age ≥ 18 years and ≤ 80 years.
  • High risk myeloma, which is untreated, defined as any of:
    • ISS stage 3 and gain of chr1q or del17p);
    • bi-allelic deletion of TP53;
    • t(4;14) or t(14;16) and gain of chr1q;
    • t(4;14) or t(14;16) and presence of del17p; or
    • presence of a high-risk gene expression signature on Sky92 assays (Skyline Diagnostics).
  • The following laboratory values obtained ≤ 14 days prior to registration.
    • Calculated creatinine clearance (using Cockcroft-Gault equation below)* ≥ 30 mL/min;
    • Absolute neutrophil count (ANC) ≥ 1000/mm^3 (without the use of growth factors);
    • Platelet count ≥ 75000/mm^3;
    • Hemoglobin ≥ 8.0 g/dL;
    • Total bilirubin ≤ 1.5 x ULN;
    • ALT and AST ≤ 3 x ULN;
    • *Cockcroft-Gault Equation:
    • Creatinine clearance for males =
    • (140
      •age)(actual body weight in kg)/ (72)(serum creatinine in mg/dL)
    • Creatinine clearance for females =
    • (140
      •age)(actual body weight in kg)(0.85)/(72)(serum creatinine in mg/dL).
  • LVEF ≥ 40%.
  • ECOG performance status (PS) 0 or 1.
  • Provide informed written consent. 
  • Negative pregnancy test done ≤ 14 days prior to registration, for women of childbearing potential only.
    • Note: All study participants must be registered into the mandatory Revlimid REMS® program and be willing and able to comply with the requirements of the REMS® program.
    • Note: Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.
  • Willing to follow strict birth control measures as outlined in the protocol.
  • Female subjects: If they are of childbearing potential, agree to one of the following:
    • Practice two effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of trial drug, AND must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable; OR
    • Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject.  (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception).
  • Male subjects: even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:
    • Agree to practice effective barrier contraception during the entire trial treatment period and through 90 days after the last dose of trial drug, OR
    • Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable; OR
    • Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject.  (Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception). 
  • Willing to return to enrolling institution for follow-up during the Active Treatment Phase of the trial.
  • Able to take aspirin (325 mg) daily as prophylactic anticoagulation. 
    • Note: Subjects intolerant to aspirin may use warfarin, novel oral anticoagulants, or low dose molecular weight heparin.
  • Male subjects must agree not to donate sperm for at least 90 days after the last dose of study treatment.
  • Willing to provide blood and bone marrow samples for planned research.
  • Life expectancy > 6 months.
  • Able to take aspirin (325 mg) daily as prophylactic anticoagulation.  Note: Subjects intolerant to aspirin may use warfarin, novel oral anticoagulants, or low dose molecular weight heparin.


Exclusion Criteria:

  • MGUS, smoldering myeloma, light chain amyloidosis with organ involvement
  • Diagnosed or treated for another malignancy ≤ 1 year prior to registration or previously diagnosed with another malignancy and have any evidence of residual disease.  Note: Subjects with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
  • If any of the following exist at screening, subject will not be eligible for trial because this trial involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
    • Pregnant women;
    • Nursing women;
    • Men or women of childbearing potential who are unwilling to employ adequate contraception (per protocol).
  • Other co-morbidity which would interfere with subject's ability to participate in trial; e.g., uncontrolled infection, uncompensated heart or lung disease.
  • Other concurrent chemotherapy, or any ancillary therapy considered investigational. 
    • NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment.
  • Peripheral neuropathy ≥ Grade 3 on clinical examination or grade 2 with pain ≤ 30 days prior to registration.
  • Major surgery ≤ 14 days prior to registration.
  • Evidence of current uncontrolled cardiovascular conditions, including hypertension, cardiac arrhythmias, congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.  Note: Prior to trial entry, any ECG abnormality at screening must be documented by the investigator as not medically relevant.
  • Known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients (refer to respective package inserts or Investigator's Brochure) or known sensitivity to mammalian-derived products.  Known allergies, hypersensitivity, or intolerance to trial drugs.
  • NYHA II, III, IV heart failure
  • Known human immunodeficiency virus (HIV) positive.
  • Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]).  Subjects with resolved infection (i.e., subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels.  Those who are PCR positive will be excluded. 
    • EXCEPTION: subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR.
  • Known or suspected active hepatitis C infection.
  • Any medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol.
  • Prior radiation therapy for bony lesions or plasmacytomasKnown allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients (refer to respective package inserts or Investigator's Brochure) or known sensitivity to mammalian-derived products.  Known allergies, hypersensitivity, or intolerance to trial drugs.
  • Inability to comply with protocol/procedures.

Eligibility last updated 3/9/22. Questions regarding updates should be directed to the study team contact.

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A Double-Blind, Randomized, Placebo Controlled, Two Period Cross-Over Study to Evaluate the Efficacy and Safety of Orvepitant in Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis (IPF-COMFORT)

Efficacy and Safety Study of Orvepitant for Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis

Vivek Iyer
All
40 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-306667-P01-RST
22-002204
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Key

Inclusion Criteria:


- Diagnosis of IPF established according to the 2018 or 2022 joint ATS/ERS/JRS/ALAT
Clinical Practice Guideline

- FEV1/FVC ratio ≥0.65 at the screening visit

- Haemoglobin-corrected diffusion capacity of carbon monoxide (Hb-corrected DLCO) ≥25%
within 12 months of the screening visit

- Arterial oxygen saturation on room air or oxygen ≥90% at Screening

- Life expectancy of at least 12 months

- Cough that is attributed to IPF, which has not responded to anti-tussive treatment,
and which has been present for at least 8 weeks prior to Screening

- Mean daily IPF Coughing Severity Scale score ≥5 (after rounding) during the second
week of the baseline assessment period

Key
Exclusion Criteria:


- Recent respiratory tract infection (<8 weeks prior to Screening)

- Recent acute exacerbation of IPF (<8 weeks prior to Screening)

- Current smokers or ex-smokers with <6 months' abstinence prior to Screening

- Emphysema ≥50% on high-resolution computed tomography, or the extent of emphysema is
greater than the extent of fibrosis according to the reported results of the most
recent scan

- Mean early morning cough scale score ≥5 and rest of the day cough scale score <5
(after rounding) during the second week of the baseline assessment period (assessed at
Visit 2)

- Cough that is predominantly productive in nature and attributable to lung pathology
such as chronic bronchitis or bronchiectasis

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 6/20/23. Questions regarding updates should be directed to the study team contact.

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A Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy for Metastatic HER2+ Breast Cancer (HER2CLIMB-05) (HER2CLIMB-05)

A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer

Ciara O'Sullivan
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2022-307417-P01-RST
22-002198
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Inclusion Criteria:

  • Centrally confirmed HER2+ breast carcinoma per 2018 American Society of Clinical Oncologists (ASCO) College of American Pathologists (CAP) guidelines.
  • Have unresectable locally advanced or metastatic disease.
  • If recurrent (after [neo]adjuvant therapy), must be at least 6 month treatment free from any trastuzumab or pertuzumab received for advanced HER2+ disease.
  • Have received 4-8 cycles (21 day cycles) of previous treatment with trastuzumab, pertuzumab, and taxane as first-line therapy for advanced HER2+ breast cancer with no evidence of disease progression.
  • Known hormone receptor status (per local guidelines; may be hormone receptor positive [HR+] or negative [HR-]).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 -CNS Inclusion.
  • Based on screening contrast brain magnetic resonance imaging (MRI), participants may have any of the following:
    • No evidence of brain metastases;
    • Untreated brain metastases which are asymptomatic and, if identified on prior brain imaging, without evidence of progression since starting first-line induction therapy with trastuzumab, pertuzumab, and taxane;
    • Previously treated brain metastases which are asymptomatic;
    • Brain metastases previously treated with local therapy must not have progressed since treatment.


Exclusion Criteria:

  • Prior treatment with any anti-HER2 and/or anti-epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor including pyrotinib, lapatinib, tucatinib, neratinib, and afatinib (except neratinib if given in extended adjuvant setting and ≥ 12 months have elapsed since last neratinib dose prior to start of study drug).
  • Unable to undergo contrast MRI of the brain -

CNS Exclusion:

  • Based on screening brain MRI and clinical assessment.
  • Symptomatic brain metastasis.
  • Progression of brain metastases since starting first line trastuzumab, pertuzumab, and taxane.
  • Ongoing use of systemic corticosteroids at a total daily dose of > 2 mg of dexamethasone (or equivalent).
  • Any untreated brain lesion in an anatomic site which may pose risk to participant.
  • Known or suspected leptomeningeal disease (LMD).
  • Poorly controlled (> 1/week) seizures, or other persistent neurologic symptoms.

Eligibility last updated 2/28/22. Questions regarding updates should be directed to the study team contact.

 

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Mayo Clinic — Rochester, MN

GUt Microbiome In Early and Established Scleroderma Study (The GUMIES study) (GUMMIES)

GUt Microbiome In Early and Established Scleroderma Study

Ashima Makol
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307806-H01-RST
22-003568
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Inclusion Criteria:

  • Age (years) ≥ 18.
  • Able to provide Written Informed consent.
  • Systemic sclerosis as defined by VEDOSS or ACR/EULAR 2013 Classification criteria.


Exclusion Criteria:

  • Individuals < 18 years.
  • History of IBD (Crohn’s disease or ulcerative colitis), microscopic colitis, or celiac disease.
  • Pregnancy.
  • Prior abdominal surgery (except hernia, fundoplication, C-section, hysterectomy, appendectomy, and cholecystectomy).
  • Prior antibiotic use or new probiotic use in the last 2 weeks.
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Study to Evaluate the Effects of BKR-017 on Insulin Sensitivity and Triglycerides in Type 1 Diabetes Subjects

Butyrate Adjuvant Therapy for Type 1 Diabetes

Adrian Vella
All
20 years to 80 years old
Phase 1/2
This study is NOT accepting healthy volunteers
0000-122318-H01-RST
19-006035
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Inclusion Criteria:


1. All type 1 diabetes with C-Peptide (CPR) less than 0.5 ng/mL subjects who are > 20 and
<80 years of age recruited from the Mayo Clinic Endocrinology Clinic;

2. Will also meet HbA1c level of 6.4-8.9% and BMI of < 30 kg/m2 at week -4.


Exclusion Criteria:


1. Except for the use of insulin, no other treatments for T1D will be permitted.

2. Pregnancy

3. Inability or unwillingness of individual or legal guardian/representative to give
written informed consent.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 2/8/23. Questions regarding updates should be directed to the study team contact.

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A Phase 1/1b Safety Study of PRGN-3006 Adoptive Cellular Therapy in Patients With CD33-Positive Relapsed or Refractory Acute Myeloid Leukemia, Minimal Residual Disease Positive Acute Myeloid Leukemia, and Higher Risk Myelodysplastic Syndrome (PRGN)

PRGN-3006 Adoptive Cellular Therapy for CD33-Positive Relapsed or Refractory AML, MRD Positive AML or Higher Risk MDS

Hassan Alkhateeb
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2021-303437-P01-RST
21-000754
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Inclusion Criteria:


- Participants must be diagnosed with either relapsed or refractory AML (including
extramedullary disease) or higher risk MDS/CMML.

- Absolute lymphocyte count ≥ 0.2 k/?L.

- Karnofsky performance status score ≥60%.

- Life expectancy ≥ 12 weeks from the time of enrollment.

- Pretreatment calculated or measured creatinine clearance (absolute value) of ≥ 40
mL/minute or Cr > 2x upper limit of normal (ULN).

- Serum bilirubin ≤ 2.0 mg/dL or total bilirubin ≤ 3.0 x IULN with direct bilirubin
within normal range in participants with well documented Gilbert's syndrome or
hemolysis or who require regular blood transfusions

- Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) < 3.0 x IULN.

- Ejection fraction measured by echocardiogram (ECHO) or multi gated acquisition scan
(MUGA) > 45%.

- Participant does not require supplemental oxygen or mechanical ventilation AND has an
oxygen saturation by pulse oximetry of ≥ 92% or higher on room air.

- Negative serum pregnancy test. Note: Women of child-bearing potential and men must
agree to use adequate contraception prior to study entry and for at least 1 year
following study treatment (T cell infusion); should a woman participant or female
partner of a male participant become pregnant or suspect that she is pregnant while
participating on the trial, she should inform her treating physician immediately.

- Participant has a matched bone marrow donor and is otherwise able to receive a bone
marrow transplant (dose escalation part only)

- Participants who have undergone allo-SCT are eligible if they are at least 3 months
post SCT, have relapsed AML/MDS as defined above, are not on treatment or prophylaxis
for GVHD for at least 6 weeks before administration of CAR T cells, and have no active
GVHD.

- All participants must have the ability to understand and willingness to sign a written
informed consent.


Exclusion Criteria:


- Diagnosis of acute promyelocytic leukemia (APL M3): t(15;17)(q22;q12); (promyelocytic
leukemia [PML]/retinoic acid receptor [RAR] alpha [a]) and variants excluded.

- Known central nervous system (CNS) leukemic involvement that is refractory to
intrathecal chemotherapy and/or cranio-spinal radiation; participants with a history
of CNS disease that have been effectively treated to complete remission ( i.e. no
blasts in cerebrospinal fluid [CSF] by cytology and flow cytometry) will be eligible.

- Prior treatment with investigational CAR T therapy for any disease.

- Participants enrolled in another investigational therapy protocol for their disease
within 14 days or 5 half-lives of enrollment, whichever is shorter.

- Ongoing uncontrolled serious infection, symptomatic congestive heart failure, unstable
angina pectoris, uncontrolled cardiac arrhythmia, poorly controlled pulmonary disease
or psychiatric illness/social situations that would limit compliance with study
requirements.

- Human immunodeficiency virus (HIV) seropositivity, or active hepatitis B or C
infection based on testing performed within 28 days of enrollment.

- Participants requiring agents other than hydroxyurea to control blast counts within 14
days of study enrollment.

- Participants with presence of other active malignancy within 1 year of study entry;

- Participants with adequately resected basal or squamous cell carcinoma of the skin, or
adequately resected carcinoma in situ (e.g. cervix) may enroll irrespective of the
time of diagnosis.

- Pregnant and lactating women are excluded from this study

- History of allergic reactions attributed to compounds of similar chemical or
biological composition to cetuximab (anti-EGFR).

- Active autoimmune disease requiring systemic immunosuppressive therapy (i.e. >10mg of
prednisone daily or equivalent).

- Participant, who in the opinion of the investigator, may not be able to comply with
the safety monitoring requirements of the study.

Eligibility last updated 6/27/22. Questions regarding updates should be directed to the study team contact.

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Feasibility of Home-based Pulmonary Rehabilitation with Remote Monitoring in Pulmonary Arterial Hypertension (PAH)

Home-based Pulmonary Rehabilitation with Remote Monitoring in Pulmonary Arterial Hypertension

Hilary DuBrock
All
18 years and over
This study is NOT accepting healthy volunteers
2022-306899-H01-RST
22-000414
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Inclusion Criteria:

  • Diagnosis of PAH, confirmed by right heart catheterization (mean pulmonary artery pressure of 20 mmHg or greater, pulmonary vascular resistance of 3.0 Woods units or greater, Pulmonary capillary wedge pressure of 15 mmHg or lower).  
  • Age ≥ 18 years.
  • On PAH-specific therapy which is at stable dosing (i.e., not currently titrating therapy).
  • NYHA class II-III symptoms.
  • able to complete a six-minute walk test.


Exclusion Criteria:

  • Patients experiencing syncope or exertional syncope.
  • Patients not experiencing exertional dyspnea.
  • Inability to walk.
  • Patients currently in pulmonary rehab or having completed pulmonary rehab within three months (unlikely to improve).

Eligibility last updated 3/14/22. Questions regarding updates should be directed to the study team contact.

 

 

 

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A222004, A Randomized Phase III Trial of Olanzapine Versus Megestrol Acetate for Cancer-Associated Anorexia

Olanzapine Versus Megestrol Acetate for the Treatment of Loss of Appetite Among Advanced Cancer Patients

Mina Hanna
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2020-300735-P01-ALCL
22-000523
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Inclusion Criteria:
-Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial. Appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives or double barrier method (diaphragm plus condom) -Diagnosis of advanced cancer -Patient-reported 2-month weight loss of at least 5 pounds (2.3 kilograms) and/or physician-estimated caloric intake of less than 20 calories/kilogram of body weight per day -The patient must perceive loss of appetite and/or weight as a problem; and have an appetite score of 4 or worse on the "Please rate your appetite…." question that requires a patient response on a 0-10 numeric rating scale -Not receiving ongoing tube feedings or parenteral nutrition at the time of registration -Not currently using systemic adrenal steroids (with the exception of short-term dexamethasone within 3 days of chemotherapy for control of chemotherapy side effects) -No use of androgens, progesterone analogs, or other appetite stimulants within the past month -Patient should not have poorly controlled hypertension or congestive heart failure at registration -Patient should not have an obstruction of the alimentary canal, malabsorption, or intractable vomiting (defined as vomiting more than 3 times per day over the preceding week) -Not currently using olanzapine for another medical condition or had previously used olanzapine for chronic nausea or for any pre-existing psychotic disorder -Patient should not have had a previous blood clot at any time in the past -No history of poorly controlled diabetes -No symptomatic leptomeningeal disease or known brain metastases as these patients may have difficulty taking oral medications -No history of hypersensitivity to olanzapine or megestrol acetate -No COVID-19 infection in the past that, in the opinion of the treating physician, had left patients with compromised taste, which has not resolved at the time of registration -Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done =< 14 days prior to registration is required -Age >= 18 years -Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 -Estimated life expectancy of 3 months or longer -Serum creatinine =< 2.0 mg/dL -Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 3 x upper limit of normal (ULN) -Fasting glucose > 1410 mg/dl -Granulocytes > 1000/hpf -No treatment with another antipsychotic agent, such as risperidone, quetiapine, clozapine, butyrophenone within 30 days of enrollment -In order to complete the mandatory patient-completed measures, participants must be able to speak and/or read English or Spanish. Sites seeking to enroll Spanish-speaking patients should have access to Spanish speaking staff on site or through the use of a translation service to be able to conduct the informed consent discussion in Spanish, and to conduct the weekly phone calls
Exclusion Criteria:
-Psychiatric illness which would prevent the patient from giving informed consent -Medical condition such as uncontrolled infection (including human immunodeficiency virus [HIV]), uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient -Patients who cannot swallow oral formulations of the agents -Patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study -No presence of a hormone-sensitive tumor, such as breast, endometrial, or prostate cancer (this exclusion criterion is intended to circumvent any confounding antineoplastic effects of megestrol acetate)

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Mayo Clinic Health System — Albert Lea, MN

North American Prodromal Synucleinopathy Consortium for RBD, Stage 2 (NAPS2) (NAPS2)

North American Prodromal Synucleinopathy Consortium for RBD

Bradley Boeve
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305130-P01-RST
21-006723
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Inclusion Criteria
•RBD Group:

  • All participants must have polysomnogram-confirmed RBD by ICSD-3 criteria [AASM 2014]. An EDF of a polysomnogram demonstrating RSWA must be available from NAPS1 or obtainable from elsewhere to verify this entry criterion.
  • Capable of providing informed consent at time of NAPS2 study enrollment, unless the participant previously enrolled in NAPS1:
    • For individuals previously enrolled in NAPS1 who developed cognitive decline and are no longer able to provide informed consent prior to enrollment in NAPS2, informed consent will be obtained from the legally authorized representative, and written assent obtained from the participant;
    • Individuals who enroll in NAPS2 will identify a proxy at initial enrollment. If a participant subsequently develops cognitive decline and is no longer able to provide informed consent for revised consent documents during follow-up visits, the proxy or legally authorized representative (depending on local regulations) will be asked to provide informed consent, and written assent obtained from the participant.
  • Age ≥ 18 years.

Exclusion Criteria
•RBD Group:

  • PD, dementia of any type, or MSA unless the individual was previously enrolled in NAPS1. Participants who phenoconvert during NAPS2 will be eligible to continue participation if they enrolled at a time when they were capable for providing informed consent.
    • Coexisting cognitive, motor, or autonomic symptoms are permitted in the RBD group provided that a diagnosis of dementia, PD, MSA, or any other overt neurodegenerative phenotype is not present;
    • The presence of “soft” cognitive, motor, autonomic, or other neurologic symptoms are appropriate for inclusion since 1) such features are common among RBD patients in the clinical setting, 2) such features are common in NAPS1participants,3) the NAPS2 program is designed to mimic recruitment of RBD patients who may be appropriate for participation in clinical trials, and 4) a primary goal of NAPS2 is to identify those at short-term risk of phenoconversion since clinical trials will focus on such RBD patient.
  • Narcolepsy-associated RBD.
  • RBD secondary to any known cause except prodromal synucleinopathy.
  • Participation in a clinical trial, except by specific permission by the Executive Committee.
  • In the opinion of the investigator, the participant has a clinically significant uncontrolled medical condition that would impede safe completion of the study protocol. 

Exclusions for Specific Procedures - RBD Group:

RBD participants will not be excluded from NAPS2 for the following exclusions; they will be excluded from undergoing the specific procedure(s).

  • Exclusions specific for MRI include any of the following:
    • metal implant or pacemaker;
    • Pregnancy;
    • Head/shoulder or body girth/weight unable to fit in the MRI scanner and coils;
    • Note that RBD participants who have claustrophobia or other issues completing MRI will not be excluded necessarily from MRI;
  • Exclusions specific for DaTscan SPECT include any of the following:
    • Pregnancy;
    • Head/shoulder or body girth/weight unable to fit in the SPECT scanner;
    • Note that RBD participants who have claustrophobia or other issues completing DaTscan will not be excluded necessarily from DaTscan;
    • Note that RBD participants who take concomitant medications that are potentially interfering for DaTscan as listed in the NI Manual of Procedures will not be excluded necessarily from DaTscan, but the specific medication(s) will be held if possible per site-specific protocols and at the discretion of the local Site Investigator. Any such medications will be noted in source documents at the time of scan.
    • History of an allergic reaction to iodine and iodine-containing products such as IV contrast dye (used for CT scans, IVPs, etc.). An allergy to shellfish is not exclusionary.
  • Exclusions specific for lumbar puncture include any of the following:
    • Diagnosis of a bleeding disorder;
    • Anticoagulant medication (coumadin, aspirin, etc.) is at the discretion of the local Site Investigator.  Site-specific procedures for lumbar puncture should be followed.

Inclusion Criteria
•Control Group:

  • Ability to provide written consent.
  • Age ≥ 18 years
  • Must meet age, sex, and race matching criteria per the DMS core recommendations for the site.
  • Must be willing and able to undergo all testing procedures, including neuroimaging and lumbar puncture.
  • Normal capacity to perform complex activities of daily living independently based on informant or physician report.

Exclusion Criteria
•Control Group:

  • History of dream enactment behavior to suggest RBD
  • Parkinsonism, MSA, dementia, or mild cognitive impairment
  • Active central nervous system, systemic, psychiatric condition or use of psychoactive medication that would adversely affect cognitive, neuropsychiatric, motor, or autonomic functioning:
    • Since the goal is to include typical normal persons, the Controls may include participants with adequately controlled medical and psychiatric conditions (based on physician determination and stratification in the RBD cohort);
    • This includes the use of stable doses of antidepressant medications, and their presence will be factored into any RBD vs Controls analyses.
  • Contraindications to complete MRI, including any of the following:
    •  
    • metal implant or pacemaker;
    • too claustrophobic to complete MRI scans;
    • previous issue completing an MRI;
    • Pregnancy;
    • Head/shoulder or body girth unable to fit in the MRI scanner and coils;
    • Body mass index > 35 kg/m^2 or weight > 300 lbs, due to neuroimaging scanner limits;
    • Participation in a clinical trial, except by specific permission by the Executive Committee;
    • In the opinion of the investigator, the participant has a clinically significant uncontrolled medical condition.
  • Contraindications to complete lumbar puncture:
    • Diagnosis of a bleeding disorder;
    • Anticoagulant medication (coumadin, aspirin, etc.) is at the discretion of the local Site Investigator.  Site-specific procedures for lumbar puncture should be followed.

Eligibility last updated 1/14/22. Questions regarding updates should be directed to the study team contact.

 

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(CAMPERR) cfMeDIP-seq Assay Multicenter Prospective Observational Validation for Early Cancer Detection, Minimal Residual Disease, and Relapse (CAMPERR)

cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease (CAMPERR)

Lisa Boardman
All
40 years and over
This study is NOT accepting healthy volunteers
2022-306871-P01-RST
22-000686
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Case

Inclusion Criteria:


- Newly diagnosed (within 90 days) with cancer or a recurrence of a cancer diagnosed > 5 years ago of one of the following subtypes: Invasive Brain, Breast, Bladder, Cervical, Colorectal, Endometrial, Esophageal, Gastric, Head and Neck, Hepatobiliary, Lung, Ovarian,  Pancreatic, Prostate, Renal, Sarcoma, Thyroid; Leukemia, Lymphoma, Multiple Myeloma.

- Able and willing to provide informed consent.

- ≥ 40 years of age.

Case
Exclusion Criteria:


- Currently receiving any treatment for cancer.

- Currently taking any demethylating agents/DNA hypomethylating agents.

- Simultaneously diagnosed with two or more invasive cancers.

- Diagnosed with any invasive or non-invasive cancer in addition to the index cancer in the last 5 years.

- Currently diagnosed with any chronic hematopoietic cancer (e.g., chronic CLL) in addition to the index cancer.

- Currently diagnosed with any myelodysplastic syndromes and/or precursor hematologic conditions (e.g., MGUS) in addition to the index cancer.

- Women who are known to be pregnant (self-reported).

Control
Inclusion Criteria:


- Not diagnosed with any cancer in the last 5 years (non-invasive cancer is allowed).

- Able and willing to provide informed consent.

- ≥ 40 years of age.

Control
Exclusion Criteria:


- Currently receiving any treatment for cancer.

- Currently taking any demethylating agents/DNA hypomethylating agents.

- Women who are known to be pregnant (self-reported).

Eligibility last updated 9/26/22. Questions regarding updates should be directed to the study team contact.

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SGNTUC-029 - An Open-label Randomized Phase 3 Study of Tucatinib in Combination With Trastuzumab and mFOLFOX6 Versus mFOLFOX6 Given With or Without Either Cetuximab or Bevacizumab as First-line Treatment for Subjects With HER2+ Metastatic Colorectal Cancer (MOUNTAINEER-03)

A Study of Tucatinib with Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer

Zhaohui Jin
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2022-307572-P01-RST
22-002828
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Inclusion Criteria:

  • Have histologically and/or cytologically documented adenocarcinoma of the colon or rectum, which is locally advanced unresectable or metastatic.
  • Subjects must be willing and able to provide the most recently available formalin-fixed paraffin-embedded tumor tissue blocks (or freshly sectioned slides, see laboratory manual for details), obtained prior to treatment initiation, to a sponsor-designated central laboratory for biomarker analysis. If archival tissue is not available, then a newly-obtained baseline biopsy of an accessible tumor lesion is required within 35 days prior to the Cycle 1 Day 1 timeframe. Biopsy must provide adequate tissue for analysis; the following biopsy types are acceptable: resection, excision, punch (skin lesions only) and core needle biopsies.
  • Have HER2+ disease as determined by tissue-based investigational HER2 IHC and ISH assays performed at a sponsor-defined central laboratory. HER2 amplification will be determined using ASCO/CAP guidelines for gastric and gastroesophageal cancer with IHC 3+ or IHC 2+/ISH+ result.
  • Have RAS WT disease as determined by local or central testing (if local testing is unavailable or is not preferred). For central RAS analysis, tissue sample must be analyzed within 1 year of biopsy date.
  • Age ≥18 years at time of consent and ≥ the age of majority per regional requirements.
  • Have radiographically measurable disease per RECIST v1.1 according to INV assessment, with at least one site of disease that is measurable and that has not been previously irradiated; or, if the subject has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation.
  • Have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
  • Life expectancy of ≥ 3 months, in the opinion of the investigator.
  • Have adequate hematological, hepatic, renal, coagulation, and cardiac function, as defined below, obtained ≤ 7 days prior to enrollment (Cycle 1 Day 1):
    • Absolute neutrophil count (ANC) ≥ 1.5 × 10^3 /µL;
    • Platelet count ≥ 100 × 10^3 /µL;
    • Hemoglobin ≥ 9.0 g/dL;
    • Total bilirubin ≤ 1.5 × upper limit of normal (ULN);
    • Subjects with known history of Gilbert’s Syndrome may enroll if direct bilirubin is ≤ 1.5 × ULN;
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN (≤ 5 × ULN if liver metastases are present);
    • Creatinine level ≤ 1.5 × institutional ULN or estimated creatinine clearance ≥60 mL/min for subjects with creatinine levels > 1.5 × institutional ULN;
    • International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN unless on medication known to alter INR and/or aPTT;
    • Left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan documented ≤ 28 days prior to study treatment.
  • For subjects of childbearing potential, the following stipulations apply:
    • Must have a negative serum pregnancy test (minimum sensitivity of 25 mIU/mL or equivalent units of beta human chorionic gonadotropin [β-hCG]) result within 7 days prior to the first dose of study treatment. A subject with a false positive result and documented verification that the subject is not pregnant is eligible for participation;
    • Must agree not to try to become pregnant during the study and for at least 7 months after the final dose of study treatment administration;
    • Must agree not to breastfeed or donate ova, starting at time of main informed consent and continuing through 7 months after the final dose of study treatment administration;
    • May choose to practice complete abstinence, if consistent with the subject’s preferred lifestyle, as an acceptable form of contraception;
    • If sexually active in a way that could lead to pregnancy, must consistently use 2 methods of birth control, as defined in Appendix B, starting at the time of main informed consent and continuing throughout the study and for at least 7 months after the final dose of any study treatment administration.
  • For subjects who can father children, the following stipulations apply:
    • Must agree not to donate sperm starting at time of main informed consent and continuing throughout the study period and for at least 7 months after the final study treatment administration;
    • If sexually active with a person of childbearing potential in a way that could lead to pregnancy, must consistently use 2 methods of birth control, as defined in Appendix B, starting at time of main informed consent and continuing throughout the study and for at least 7 months after the final dose of study treatment administration;
    • If sexually active with a person who is pregnant or breastfeeding, must consistently use one of 2 contraception options, as defined in Appendix B, starting at time of main informed consent and continuing throughout the study and for at least 7 months after the final dose of study treatment administration;
    • May choose to practice complete abstinence, if consistent with the subject’s preferred lifestyle, as an acceptable form of contraception.
  • Subject must provide signed informed consent that has been approved by an institutional review board/independent ethics committee (IRB/IEC) prior to initiation of any study-related tests or procedures. 
  • Subject must be willing and able to comply with study procedures.
  • Subject must be willing and able to adhere to mandatory antidiarrheal prophylaxis.
  • CNS Inclusion—Based on screening contrast brain magnetic resonance imaging (or CT with contrast if MRI is contraindicated), subjects may have any of the following:
    • No evidence of brain metastases;
    • Previously treated brain metastases which are asymptomatic.
    • Brain metastases previously treated with local therapy must not have progressed since treatment;
    • Time since whole brain radiation therapy (WBRT) is ≥ 14 days prior to enrollment, time since stereotactic radiosurgery (SRS) is ≥ 7 days prior to enrollment, or time since surgical resection is ≥ 28 days prior to enrollment;
    • Relevant records of any CNS treatment must be available to allow for classification of target and non-target lesions.


Exclusion Criteria:

  • Have previously received any systemic anticancer therapy for CRC in the metastatic setting or have participated in any interventional clinical trial for CRC in the metastatic setting; note that subjects may have received a maximum of 2 doses of mFOLFOX6 in the locally advanced/unresectable or metastatic setting prior to randomization.
    • Note: subjects may have received prior chemotherapy for CRC in the adjuvant setting provided that it was completed > 6 months prior to enrollment.
  • Have previously received radiation therapy within 14 days prior to enrollment (or within 7 days in the setting of SRS). Subjects who have received prior radiation therapy must have recovered to baseline from any treatment-related adverse events (AEs). Subjects who have received palliative radiotherapy for symptomatic metastases may enter the study without a washout period provided that the subject has recovered from any treatment-related AEs.
  • Have previously been treated with anti-HER2 therapy.
  • Have any toxicity related to prior cancer therapies that has not resolved to ≤ Grade 1, with the following exceptions:
    • Neuropathy, which must have resolved to ≤ Grade 2;
    • Alopecia;
    • Congestive heart failure (CHF), which must have been ≤ Grade 1 in severity at the time of occurrence, and must have resolved completely;
    • Anemia, hemoglobin must have resolved to a level of ≥9.0 g/dL 5. Have clinically significant cardiopulmonary disease such as:
    • Ventricular arrhythmia requiring therapy;
    • Symptomatic hypertension or uncontrolled asymptomatic hypertension, as determined by the investigator;
    • Any history of symptomatic CHF (Grade 2 or above), symptomatic left ventricular systolic dysfunction or symptomatic decrease in ejection fraction;
    • Severe dyspnea at rest (Grade 3 or above) due to complications of advanced malignancy or hypoxia requiring supplementary oxygen therapy;
    • Presence of ≥ Grade 2 corrected QT interval (QTc) prolongation (>480 ms) on screening electrocardiogram (ECG);
    • Interstitial lung disease or pneumonitis;
    • Have a history of transient ischemic attack, cerebrovascular accident, myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or cardiac surgery within 6 months prior to enrollment (Cycle 1 Day 1).
    • Have a history of a significant bleeding events within 6 months of enrollment, unless the source of bleeding has been definitively treated.
    • Have a history of gastrointestinal (GI) perforation within 12 months of enrollment.
    • Have ongoing ≥ Grade 2 diarrhea of any etiology.
    • Major surgical procedure or significant traumatic injury ≤ 28 days prior to enrollment (≤ 56 days for hepatectomy, open thoracotomy, or major neurosurgery) or anticipation of need for major surgical procedure during the course of the study.
    • Serious, non-healing wound, ulcer, or bone fracture.
    • Positive for hepatitis B by surface antigen expression.
    • Presence of known chronic liver disease.
    • Have active hepatitis C infection (positive by PCR or on antiviral therapy for hepatitis C within the last 6 months). Subjects who have been treated for hepatitis C infection are permitted if they have documented sustained virologic response of 12 weeks.
  • Subjects known to be positive for human immunodeficiency virus (HIV) are excluded if they meet any of the following criteria:
    • CD4+ T-cell count of <350 cells/µL;
    • Detectable HIV viral load;
    • History of an opportunistic infection within the past 12 months;
    • On stable antiretroviral therapy for < 4 weeks.
  • Subjects who are pregnant, breastfeeding, or planning a pregnancy.
  • Inability to swallow pills or any significant GI disease which would preclude the adequate oral absorption of medications.
  • Have used a strong cytochrome p450 (CYP) 2C8 inhibitor within 5 half-lives of the inhibitor, or have used a strong CYP2C8 or CYP3A4 inducer within 5 days prior to first dose of study treatment.
  • Have any other medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures.
  • History of another malignancy within 3 years before the first dose of study treatment, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.
  • Subjects with active CNS metastases (irradiated or resected lesions are permitted).
  • Subjects with carcinomatous meningitis are excluded without exception.
  • Have a known hypersensitivity or allergy to any of the study treatments or any of their excipients, or to required concomitant medications, or to murine proteins, except for Grade 1 or 2 infusion-related reactions (IRRs) to oxaliplatin that were successfully managed.
  • Have received a live vaccine <30 days prior to enrollment.
  • Have known dihydropyrimidine dehydrogenase (DPD) deficiency.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/5/23. Questions regarding updates should be directed to the study team contact.

Drug, Biologic/Vaccine
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