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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.

3289 Study Matches

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Ex-vivo Surfaceomics of Patient-Derived Tumors for Next-Generation Cancer Immunotherapies (EVST)

Study of Cell-surface Proteins in Renal Tumors for Future Exploration of New Anticancer Therapies

Fabrice Lucien-Matteoni
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305283-H01-RST
21-006091
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Inclusion Criteria:

  • Age 18+.
  • Able to give informed consent.
  • Newly diagnosed clear-cell renal cell carcinoma.
  • Eligible for radical nephrectomy.


Exclusion Criteria:

  • Unable or unwilling to provide informed consent.
  • No previous systemic therapy.
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PISTACHIO (PREEMPTIION OF DISRUPTIVE BEHAVIOR IN CHILDREN) REAL-TIME MONITORING OF SLEEP AND BEHAVIOR OF CHILDREN 3-7-YEAR-OLD RECEIVING PARENT CHILD INTERACTION THERAPY AUGMENTED WITH ARTIFICIAL INTELLIGENCE RANDOMIZED CONTROLLED TRIAL. (PISTACHIO)

Monitoring of Sleep and Behavior of Children 3-7 Years Old Receiving Parent-Child Interaction Therapy with the Help of Artificial Intelligence

Paul Croarkin
All
3 years to 99 years old
Phase 1
This study is NOT accepting healthy volunteers
2021-305294-H01-RST
21-007403
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Inclusion Criteria
•Children:

  • Ages 3-7.
  • Outpatients or Inpatients.
  • Any gender, race or ethnicity.
  • Able to provide developmentally appropriate informed assent, and legal guardians able to provide informed consent .
  • EBP Severity rated above the clinically significant range (≥120; T-score ≥ 60) (Eyberg Child Behavior Inventory- ECBI; Eyberg & Pincus, 1999).
  • Need for more intensive behavioral treatments such as ER visit for behavioral dyscontrol or hospitalization will not be exclusionary or exit criteria.
  • Families approached for participation will be asked to commit to complete the treatment.
  • At least one primary caregiver and the identified child will have to be able to speak and understand English.   

 Exclusion Criteria
•Children:

  • Formal diagnosis of Severe Intellectual disability, Autistic Spectrum Disorder Level 3, or a psychotic disorder for the child.
  • Parents not consenting to the study.
  • Parents or child is not able to adhere to the study protocol.
  • A Child who is reasonable expected to be unable to tolerate wearing the Garmin device for at least 70% of the time during the day and night 70% of the days during the treatment (12 weeks). This is based on the principal investigator’s discretion.
  • Unable to speak and understand English. 
  • Refusal or withdrawal of consent, inability, or unwillingness to adhere to study procedures.
  • Children in foster care.

Inclusion Criteria
•Adults:

  • Agree to wear Garmin watch.
  • Ages 18-99.
  • Any gender, race, ethnicity.
  • Able to provide informed consent.

Exclusion Criteria
•Adults:

  • Unable to speak and understand English. 
  • Refusal or withdrawal of consent, inability, or unwillingness to adhere to study procedures.
Behavioral
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Home Visual Acuity Testing (X06)

Home Visual Acuity Testing

Erick Bothun
All
3 years to 17.5 years old
This study is NOT accepting healthy volunteers
2021-305312-P01-RST
21-007441
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Inclusion Criteria:

  • Age 3 to 17.5 years.
  • If the child wears contact lenses, the child must be able to perform all testing (in office and at home) in spectacle correction without contact lenses.

Eligible families will:

  • Have an iPhone 6 or a later version (excluding first generation iPhone SE) with them at the office visit.
  • The iPhone screen must not have cracks or damage that would decrease legibility of the letters presented (The screen will be checked by a study team member to assure there is no screen damage that would affect legibility of optotypes).
  • Be able to successfully download the age appropriate (ATS-HOTV or e-ETDRS) iPhone application to their iPhone, with assistance from office staff, if needed.
  • Successfully perform the phone-based VA test at the enrollment visit with the participant wearing his/her current optical correction (if worn), with assistance from office staff, if needed.
  • Be able to use the same iPhone to measure VA at home.
  • Be able to have the same adult administer the home VA test for all required home VA tests.
  • Be able and willing to test VA at home 3 days after enrollment (Home test 1) and 1 day after Home test 1 (Home test 2).
  • Be willing to test VA at home within 2 days prior to a subsequent return office visit 3 months after enrollment.
  • Be willing to return for a 3-month office visit.

Participant


Exclusion Criteria:

  • Use of atropine in the last 30 days, including the day of enrollment.
  • Use of atropine expected in the upcoming four months.
  • Aphakia (one or both eyes).
  • Dilation and cycloplegia within 48 hours of the first in-office VA measure.
  • Any cognitive or physical limitations of the participant or parent that would limit their.
  • Ability to perform the phone-based testing at home or in-office testing.

 

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Observational Feasibility Study of the Healthdot Wearable Monitoring Device in Bariatric Patients at Mayo Clinic (OHD)

Observational Study of Wearable Health Monitoring Device

Eric Vargas Valls
All
22 years to 60 years old
This study is NOT accepting healthy volunteers
2021-305321-H01-RST
21-007489
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Inclusion Criteria:
  

  • Age 22 to 60.
  • Patients being seen for upcoming planned weight-loss procedure (ESG, Balloon, Bariatric Surgery, Revision after Bariatric Surgery).
  • Commitment to wear device without removing for entire study period.
  • Located within a driving distance from Mayo Clinic in Rochester, Minnesota during study duration.
  • Reside in an area with 4G or 5G connectivity based on cellphone provider maps for T-Mobile or AT&T.
  • Subject clear of any dermatologic health diagnosis that may impede the ability of the device to adhere properly.


Exclusion Criteria:
   

  • Unable to give consent.
  • Unwillingness to utilize email address for device instructions, surveys, and reminders.
  • Lifestyle that would have the device exposed to excessive elements for a prolonged period of time outside the parameters of normal operation of the device.
  • Patient is expected/anticipated to fly (use an airplane) before study completion (before Day 10).
  • Subjects with a pacemaker or an implanted electronic device.
  • Subjects scheduled or likely to conduct MRI within the study period.
  • Left lower rib (place where Healthdot will be applied) is involved in the area of surgery, area of disinfection or area where bandages are needed.
  • Patients with severe systemic diseases.

Eligibility last updated 2/24/22. Questions regarding updates should be directed to the study team contact.

 

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Profiling of Tumor-Derived Extracellular Vesicles and Circulating CD8+-T cells for Prediction of Response to Immunotherapy in Metastatic Renal Cell Carcinoma (RCCEV)

Predicting Immunotherapy Response in Metastatic Kidney Cancer

Fabrice Lucien-Matteoni
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305346-H01-RST
21-006090
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Inclusion Criteria:

  • Age 18+.
  • Able to give informed consent.
  • Newly diagnosed metastatic renal cell carcinoma.
  • Eligible for immunotherapy.


Exclusion Criteria:

  • Unable of unwilling to provide informed consent.
  • Previous systemic therapy.

Eligibility last updated 8/11/21. Questions regarding updates should be directed to the study team contact.

 

 

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BAY 1895344 Plus Topoisomerase-1 (Top1) Inhibitors in Patients with Advanced Solid Tumors, Phase I Studies with Expansion Cohorts in Small Cell Lung Carcinoma (SCLC), Poorly Differentiated Neuroendocrine Carcinoma (PD-NEC) and Pancreatic Adenocarcinoma (PDA), 10402 (BAY 1895344)

BAY 1895344 Plus Topoisomerase-1 (Top1) Inhibitors in Patients with Advanced Solid Tumors, Phase I Studies with Expansion Cohorts in Small Cell Lung Carcinoma (SCLC), Poorly Differentiated Neuroendocrine Carcinoma (PD-NEC) and Pancreatic Adenocarcinoma (PDA)

Thorvardur Halfdanarson
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2021-305360-P01-RST
21-007668
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Inclusion Criteria:


- DOSE ESCALATION COHORTS: Patients must have a biopsy-proven solid tumor that is
metastatic or unresectable and has progressed on at least one line of standard therapy

- DOSE ESCALATION COHORTS: Patients must have a solid tumor for which irinotecan or
topotecan is considered standard of care

- DOSE EXPANSION COHORTS: Patients must have biopsy proven metastatic or unresectable
small cell lung cancer (SCLC), poorly differentiated neuroendocrine carcinoma (PD-NEC)
(any extrapulmonary neuroendocrine carcinoma with small cell or large cell histology)
or pancreatic adenocarcinoma (PDA) and have progressed on at least one line of
standard therapy

- DOSE EXPANSION COHORTS: Patients must have at least one measurable lesion outside of
the lesion to be biopsied

- Patients must be able to swallow pills

- Age >= 18 years. Because no dosing or adverse event data are currently available on
the use of BAY 1895344 in combination with irinotecan or topotecan in patients < 18
years of age, children are excluded from this study

- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

- Hemoglobin > 9 g/dL

- Absolute neutrophil count >= 1,500/mcL

- Platelets >= 100,000/mcL

- Total bilirubin =< 2 x institutional upper limit of normal (ULN)

- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
=< 3 x institutional ULN

- Glomerular filtration rate (GFR) >= 60 mL/min/1.73 m^2

- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral
therapy with undetectable viral load within 6 months are eligible for this trial

- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral
load must be undetectable on suppressive therapy, if indicated

- Patients with a history of hepatitis C virus (HCV) infection must have been treated
and cured. For patients with HCV infection who are currently on treatment, they are
eligible if they have an undetectable HCV viral load

- Patients with treated brain metastases are eligible if follow-up brain imaging after
central nervous system (CNS)-directed therapy shows no evidence of progression.
Furthermore, these patients must be asymptomatic from previously treated brain
metastases (e.g. not on steroids for neurologic symptoms within 30 days of study
enrollment)

- Patients with a prior or concurrent malignancy whose natural history or treatment does
not have the potential to interfere with the safety or efficacy assessment of the
investigational regimen are eligible for this trial

- Patients with known history or current symptoms of cardiac disease, or history of
treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac
function using the New York Heart Association Functional Classification. To be
eligible for this trial, patients should be class 2B or better

- The effects of BAY 1895344 on the developing human fetus are unknown. For this reason
and because DNA-damage response inhibitors as well as other therapeutic agents used in
this trial are known to be teratogenic, women of child-bearing potential and men must
agree to use adequate contraception (hormonal or barrier method of birth control;
abstinence) prior to study entry and for the duration of study participation and for 6
months after completion of BAY 1895344 administration. Should a woman become pregnant
or suspect she is pregnant while she or her partner is participating in this study,
she should inform her treating physician immediately. Men treated or enrolled on this
protocol must also agree to use adequate contraception prior to the study, for the
duration of study participation, and 6 months after completion of BAY 1895344
administration

- Patient must have the ability to understand and the willingness to sign a written
informed consent document. Participants with impaired decision-making capacity (IDMC)
who have a legally-authorized representative (LAR) and/or family member available will
also be eligible


Exclusion Criteria:


- Patients who have previously been treated with irinotecan will not be eligible to
participate in the irinotecan arm and patients who have previously been treated with
topotecan will not be eligible to participate in the topotecan arm. However, patients
who previously received irinotecan may be treated with topotecan (and vice versa)
should the other agent be considered a possible standard of care for their disease.
Patients who have previously been treated with BAY 1895344 will be excluded from the
study

- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study

- Patients who have not recovered from adverse events due to prior anti-cancer therapy
(i.e., have residual toxicities > grade 1) with the exception of alopecia and
endocrinopathies from prior immunotherapy

- Patients who are receiving any other investigational agents

- The investigator(s) must state a medical or scientific reason if patients who have
brain metastases will be excluded from the study

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to BAY 1895344 or other agents used in study

- Patients receiving any medications or substances that are substrates of CYP3A4 with a
narrow therapeutic window, or strong inhibitors/inducers of CYP3A4 are ineligible, if
they cannot be transferred to alternative medication. Because the lists of these
agents are constantly changing, it is important to regularly consult a
frequently-updated medical reference. As part of the enrollment/informed consent
procedures, the patient will be counseled on the risk of interactions with other
agents, and what to do if new medications need to be prescribed or if the patient is
considering a new over-the-counter medicine or herbal product

- Patients with uncontrolled intercurrent illness

- Patients with psychiatric illness/social situations that would limit compliance with
study requirements

- Pregnant women are excluded from this study because BAY 1895344 is agent with the
potential for teratogenic or abortifacient effects. Because there is an unknown but
potential risk for adverse events in nursing infants secondary to treatment of the
mother with BAY 1895344, breastfeeding should be discontinued if the mother is treated
with BAY 1895344. These potential risks may also apply to other agents used in this
study

- Patients with an uncontrolled infection requiring IV antibiotics will not be eligible
to participate in the study

- Patients on strong CYP3A4 inhibitors must discontinue them at least 1 week prior to
starting irinotecan therapy

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

Eligibility last updated 9/19/22. Questions regarding updates should be directed to the study team contact.

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EA8192, A Phase II/III Trial of MEDI4736 (Durvalumab) and Chemotherapy for Patients With High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy

Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer

Lance Pagliaro
All
18 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
2021-305361-P01-RST
21-007652
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Inclusion Criteria:

  • Patient must have the ability to understand and the willingness to sign a written informed consent document.
  • Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible.
  • Patient must have a diagnosis of high grade upper tract urothelial carcinoma proven by biopsy within 60 days prior to registration with one of the following:
    • Upper urinary tract mass on cross-sectional imaging; or
    • Tumor directly visualized during upper urinary tract endoscopy before referral to medical oncology;
      • NOTE: Biopsy is standard of care (SOC) and required for enrollment to study. This is vital for best practice.
    • Leukocytes ≥ 3,000/mcL (obtained ≤ 14 days prior to registration);
    • Platelets ≥ 100,000/mcL (obtained ≤ 14 days prior to registration);
    • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (or ≤ 2.5 x ULN for patients with Gilbert's disease) (obtained ≤ 14 days prior to registration);
    • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 x institutional ULN (obtained ≤ 14 days prior to registration);
    • Hemoglobin (Hgb) ≥ 9 g/dL (obtained ≤ 14 days prior to registration);
      • NOTE: Packed red blood transfusion is allowed to achieve this parameter as per treating investigator.
    • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial;
      • NOTE: These patients must be stable on their anti-retroviral regimen with evidence of at least two undetectable viral loads within the past 6 months on the same regimen; the most recent undetectable viral load must be within the past 12 weeks. They must have a CD4 count of greater than 250 cells/mcL over the past 6 months on this same anti-retroviral regimen and must not have had a CD4 count < 200 cells/mcL over the past 2 years, unless it was deemed related to the cancer and/or chemotherapy induced bone marrow suppression. They must not be currently receiving prophylactic therapy for an opportunistic infection and must not have had an opportunistic infection within the past 6 months.
      • NOTE: For patients who have received chemotherapy in the past 6 months, a CD4 count < 250 cells/mcL during chemotherapy is permitted as long as viral loads were undetectable during this same chemotherapy. They must have an undetectable viral load and a CD4 count ≥ 250 cells/mcL within 7 days of registration.
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
    • NOTE: Testing for HIV, hepatitis B or hepatitis C is not required unless clinically indicated.
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and have undetectable viral load. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
  • Patient must have a body weight of > 30 kg.
  • Patient must have a life expectancy of ≥ 12 weeks.
  • Patient must have a creatinine clearance > 15 ml/min as by Crockroft-Gault or 24-hour creatinine clearance within 28 days prior to registration.
    • NOTE: Patients will be assigned to cisplatin-ineligible and cisplatin-eligible cohorts based on their creatinine clearance, Eastern Cooperative Oncology Group (ECOG) performance status, and grade (if any) of peripheral neuropathy and hearing loss in keeping with SOC cisplatin contraindications.
  • Patients that are cisplatin-eligible will be randomized to either Arm A or Arm B.
  • Patients that meet the following criteria will be assigned to the cisplatin-ineligible Arm C:
    • Creatinine clearance of > 15 ml/min and ≤ 50 ml/min;
    • Patient must have an absolute neutrophil count (ANC) ≥ 1,000/mcL obtained ≤ 14 days prior to registration;
    • Patient must have ECOG performance status 0-2.
  • Patients that meet the following criteria will be randomized to cisplatin-eligible Arm A or Arm B:
    • Patient must have an absolute neutrophil count (ANC) ≥ 1,500/mcL obtained ≤ 14 days prior to randomization;
    • Patient must have ECOG performance status 0-1;
    • Patient must have left ventricular ejection fraction (LVEF) ≥ 50% by (either multigated acquisition scan [MUGA] or 2-D echocardiogram) obtained within 28 days prior to randomization;
    • Patient must not have peripheral neuropathy ≥ grade 2 or hearing loss ≥ grade 3.


Exclusion Criteria:

  • Patients must not have any component of small cell carcinoma. Other variant histologic types are permitted provided the predominant (≥ 50%) subtype is urothelial carcinoma.
  • Patients must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. A patient of childbearing potential is defined as any patient, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
    • Has achieved menarche at some point;
    • Has not undergone a hysterectomy or bilateral oophorectomy; or
    • Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months);
    • Patients of childbearing potential and sexually active patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse from the time of registration, while on study treatment and for at least 6 months after the last dose of protocol treatment.
  • Patient must have no evidence of metastatic disease or clinically enlarged lymph nodes (≥ 1.0 cm short axis) on imaging required within 28 days prior to registration (solitary slightly enlarged lymph node with negative biopsy is allowed).
    • NOTE: Patients with elevated alkaline phosphatase, calcium or suspicious bone pain/tenderness should also undergo baseline bone scans to evaluate for bone metastasis.
  • Patient must not have another active (or within 2 years) second malignancy other than resected non-melanoma skin cancers, resected in situ breast, cervical or other in situ carcinoma, and either clinically insignificant per the investigator (e.g., ≤ Gleason 3+4) on surveillance or previously treated prostate cancer with no rising prostate specific antigen (PSA) and no plan to treat.
    • NOTE: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • Patients in whom concomitant or prior bladder/urethra predominant (≥ 50%) urothelial carcinoma have been surgically resected and demonstrated to be only non-invasive cancer (< cT1N0) are eligible regardless of time elapsed.
  • Patient must not have any uncontrolled illness including, but not limited to, ongoing or active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis [TB] testing in line with local practice), symptomatic congestive heart failure (CHF), myocardial infarction (MI) in last 3 months, or unstable angina pectoris, significant uncontrolled cardiac arrhythmia, liver cirrhosis, interstitial lung disease, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patient must not have received prior radiation therapy to ≥ 25% of the bone marrow for other diseases.
  • Patient must not have received prior systemic anthracycline therapy.
    • NOTE: Patients who have received prior intravesical chemotherapy at any time for non-muscle invasive urothelial carcinoma of the bladder are eligible.
  • Patient must not have an active autoimmune disease requiring immunosuppressive therapy within 2 years prior to registration or a history of inflammatory bowel disease (inflammatory bowel disease [IBD], colitis, or Crohn's disease), systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome or immune-related pneumonitis or interstitial lung disease.
  • Patients with well-controlled hyper/hypothyroidism, celiac controlled by diet alone, diverticulosis, diabetes mellitus type I, vitiligo, alopecia, psoriasis, eczema, lichen planus, or similar skin/mucosa condition.
  • Patient must not be on or have used immunosuppressive medication within 14 days prior to the first dose of MEDI4736 (MEDI4736 (durvalumab). The following are exceptions to this criterion:
    • Intranasal, inhaled, intra-auricular, topical steroids, or local steroid injections (e.g., intra-articular injection;
    • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent at the time of enrollment;
    • Steroids as premedications for hypersensitivity reactions (e.g., computed tomography [CT] scan premedication);
    • Patient must not have a concomitant primary urothelial carcinoma of the bladder and/or urethra;
    • NOTE: Patients in whom concomitant or prior bladder/urethra predominant (≥ 50%) urothelial carcinoma have been surgically resected and demonstrated to be only non-invasive cancer (< cT1N0) are eligible regardless of time elapsed.
  • Patient must not have prior history of muscle-invasive urothelial carcinoma with or without systemic chemotherapy (T2-4a and/or N1) within 2 years prior to registration.
    • NOTE: Patients who have no evidence of disease (NED) for more than 2 years from the latest therapy (surgery, radiation, chemotherapy, or clinical trial).
  • Patient must not have received live attenuated vaccine within 30 days prior to the first dose of MEDI4736 (durvalumab), while on protocol treatment and within 30 days after the last dose of MEDI4736 (durvalumab).
  • Patient must not have had a major surgical procedure (as defined by the Investigator) within 28 days prior to registration.
  • Patient must not have a history of allogenic organ transplantation.
Biologic/Vaccine, Drug, Procedure/Surgery
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HS-19-657, A Randomized, Multi-center, Open-label, Active-controlled Phase 3 Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) Versus Octreotide LAR or Lanreotide ATG in Patients With GEP-NET (SORENTO)

A Trial to Assess Effectiveness and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET

Thorvardur Halfdanarson
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-305363-P01-RST
21-007673
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Inclusion Criteria:

  • Male or female patient ≥ 18 years old.
  • Histologically confirmed, advanced (unresectable and/or metastatic), and well-differentiated NET of GEP or presumed GEP origin.
  • At least 1 measurable, somatostatin receptor-positive lesion according to RECIST 1.1 determined by multiphasic CT or MRI (performed within 28 days before randomization).
  • ECOG performance status of 0 to 2.


Exclusion Criteria:

  • Individuals < 18 years old.
  • Documented evidence of disease progression while on treatment (including SSAs) for locally advanced unresectable or metastatic disease.
  • Known central nervous system metastases.
  • Consecutive treatment with long-acting SSAs for more than 6 months before randomization.
  • Carcinoid symptoms that are refractory to treatment (according to the Investigator's judgement) with conventional doses of octreotide LAR or lanreotide ATG and/or to treatment with daily doses of ≤600 µg of octreotide IR.
  • Previous treatment with more than 1 cycle of targeted therapies such as mTOR inhibitors or vascular endothelial growth factor inhibitors, or more than 1 cycle of chemotherapy or interferon for GEP-NET
  • Treatment of GEP-NET with trans-arterial chemoembolization or trans-arterial embolization within 12 months before screening.
  • Previously received radioligand therapy (PRRT) at any time..

Eligibility last updated 12/30/21. Questions regarding updates should be directed to the study team contact.

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Patient Preferences for Second-line Type 2 Diabetes Medication Treatment Outcomes

Patient Preferences for Second-line Type 2 Diabetes Medication Treatment Outcomes

Rozalina McCoy
All
21 years and over
This study is NOT accepting healthy volunteers
2021-305377-H01-RST
21-007688
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Inclusion Criteria:

  • ≥ 21 years old.
  • Diagnosis of Type 2 diabetes.
  • Use of ≥ study drug (GLP-1RA, SGLT2i, DPP-4i, SU).


Exclusion Criteria:

  • Insulin use.
  • Cognitive impairment.
  • Terminal or advanced illness.
  • Non-English speaking.
  • Residency in a long-term care setting.
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A Prospective, Multi‐Center Study of the Medtronic Braive™ Growth Modulation System When Used in the Treatment of Pediatric Patients Diagnosed with Juvenile or Adolescent Idiopathic Scoliosis (BRAIVE IDE Study) (BRAIVE IDE)

Study of the Braive Growth Modulation System for Progressive Pediatric Scoliosis (BRAIVE IDE)

Annalise Larson
All
9 years to 16 years old
This study is NOT accepting healthy volunteers
2021-305386-P01-RST
21-007823
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Inclusion Criteria:

  • Has a diagnosis of juvenile or adolescent idiopathic scoliosis.
  • Is skeletally immature with a Sanders Score of ≥ 2 to ≤ 5.
  • Has failed conservative care as per investigator’s assessment.
  • Has a main thoracic Cobb angle between 30 and 60 degrees.
  • Has a Lenke Classification of 1A, 1B, or 1C.
  • Has kyphosis ≤ 40 degrees with a sagittal thoracic modifier N or negative.
  • Informed Consent Form/Assent and Authorization to Use and Disclose Health Information (if applicable) have been signed by parent/legal guardian and/or patient/participant per local requirement.


Exclusion Criteria:

  • Has undergone previous spinal fusion procedure(s) at the affected levels.
  • Is pregnant or plans to become pregnant within the first 24‐months of the study.
  • Has a curve that requires instrumentation below L1.
  • Has spinal MRI abnormalities (e.g., CHIARI malformation, Syrinx greater than 4mm, tethered cord).
  • Has any type of non‐idiopathic scoliosis.
  • Has a left‐sided curve.
  • Has an associated syndrome.
  • Has a history of malignant hyperthermia.
  • Has an active or significant risk of infection (immunocompromised).
  • Has inadequate tissue coverage over the operative site as per investigator’s assessment.
  • Has a suspected or documented allergy or intolerance to implant materials.
  • Has a major psychiatric disorder/ history of drug abuse that would interfere with the subject’s ability to comply with study instructions or might confound the study interpretation as per investigator’s assessment (DSM‐5 can be used as a reference).
  • Is a ward of the court/state.
  • Has had prior ipsilateral or contralateral chest surgery.
  • Has severe chronic lung disease (e.g., asthma, bronchiectasis).
  • Has poor bone quality, as determined by the investigator, that may limit anterior fixation.
  • Is unwilling or unable to return for follow‐up visits and/or follow intra‐operative and/or postoperative instructions.
  • Concurrent participation in another clinical study that may add additional safety risks and/or confound study results*.
  • Subjects in concurrent studies can only be enrolled with permission from Medtronic. Please contact Medtronic’s study manager to determine if the subject can be enrolled in the BRAIVE IDE Study.

*Subjects in concurrent studies can only be enrolled with permission from Medtronic. Please contact Medtronic’s study manager to determine if the subject can be enrolled in the BRAIVE IDE Study. 

Eligibility last updated 11/16/21. Questions regarding updates should be directed to the study team contact.

 

 

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EA2192 APOLLO: A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Adjuvant Chemotherapy in Patients With Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation (EA2192)

A Randomized Study of Olaparib or Placebo in Patients With Surgically Removed Pancreatic Cancer Who Have a BRCA1, BRCA2 or PALB2 Mutation, The APOLLO Trial

Robert McWilliams
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-305388-P01-RST
21-008248
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Inclusion Criteria:

STEP 0 (PRE-REGISTRATION) INCLUSION CRITERIA

  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Patient must have a diagnosis of pancreatic cancer and have successfully undergone a curative intent surgical resection and must have no evidence of recurrent disease as determined by the investigator.
    • NOTE: This includes patients with adenocarcinoma, acinar carcinoma, squamous cell carcinoma adenosquamous and variants thereof. Patients with neuroendocrine tumors are excluded from enrolling.
  • Patient must be planning to receive, be receiving or be within 8 weeks of having completed at least three combined months (i.e., 12 weeks) of perioperative (neoadjuvant, adjuvant or a combination of both). systemic, multi-agent chemotherapy. Patients may have had up to 6 months of perioperative systemic therapy as deemed appropriate by their primary treating medical team (patients can have received radiation or chemoradiation in addition to this 6 month course).
  • Patient must have a known pathogenic or likely pathogenic germline or somatic mutation in BRCA1, BRCA2, or PALB2, as determined by a Clinical Laboratory Improvement Amendments (CLIA) certified or equivalently-accredited laboratory. Mutations must be considered pathogenic or likely pathogenic by a reference database such as ClinVar or OncoKb.org.

STEP 1 (RANDOMIZATION) INCLUSION CRITERIA

  • Patient must have undergone at least 3 combined months (i.e., 12 weeks) of perioperative (neoadjuvant, adjuvant or a combination of both) systemic, multi-agent chemotherapy. Patients may have had up to 6 months of perioperative systemic therapy as deemed appropriate by their primary treating medical team (patients can have received radiation or chemoradiation in addition to this 6 months course).
  • Central expert reviewer must have determined the patient eligible for randomization after review of local genetic testing reports.
  • If mutation in BRCA1, BRCA2 or PALB2 was identified in tumor tissue and the patient has not previously undergone germline testing, the patient must agree to undergo germline testing.
  • Patient must not have previously had evidence of progressive pancreatic cancer while receiving platinum-based therapy.
  • Patient must be ≥ 21 days (three weeks) from their last treatment (including chemotherapy or radiotherapy) but ≤ 56 days (eight weeks) from their last treatment. Patients who have received neoadjuvant and/or adjuvant radiotherapy are eligible.
  • Patient must have recovered from any adverse events due to prior anti-cancer therapy (i.e., have no residual toxicities > grade 1 with the exception of alopecia and/or neuropathy).
  • Leukocytes ≥ 3,000/mcL (obtained ≤ 14 days prior to randomization).
  • Absolute neutrophil count ≥ 1,500/mcL (obtained ≤ 14 days prior to randomization).
  • Platelets ≥ 100,000/mcL (obtained ≤ 14 days prior to randomization).
  • Hemoglobin ≥ 10.0 g/dL with no blood transfusion in the past 28 days (obtained ≤ 14 days prior to randomization).
  • Total bilirubin ≤ institutional upper limit of normal (ULN) except in patients with Gilbert's syndrome. Patients with Gilbert's syndrome may enroll if direct bilirubin ≤ 2.5 ULN of the direct bilirubin (obtained ≤ 14 days prior to randomization).
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 institutional ULN (obtained ≤ 14 days prior to randomization).
  • Creatinine ≤ institutional ULN OR calculated Cockcroft Gault creatinine clearance > 50 mL/min/1.73 m^2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m^2 (obtained ≤ 14 days prior to randomization).
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
  • Patient must have the ability to understand the willingness to sign a written informed consent document, or have legally authorized representative provide authorization to participate.


Exclusion Criteria:

STEP 1 (RANDOMIZATION) EXCLUSION CRITERIA

  • Patient must have no evidence of recurrent or metastatic pancreatic cancer at the time of randomization as documented by baseline scans obtained ≤ 4 weeks prior to randomization.
  • Patient must not be receiving any other investigational agents at the time of randomization and while on protocol treatment.
  • Patient must not have any history of allergic reactions attributed to compounds of similar chemical or biological composition to olaparib.
  • Patient must not have any personal history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML.
  • Patient must not have any uncontrolled gastrointestinal disorder that would, in the opinion of the investigator, interfere with the ingestion or absorption of olaparib.
  • Patient must not be pregnant or breast-feeding due the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
    • has achieved menarche at some point;
    • has not undergone a hysterectomy or bilateral oophorectomy; or
    • has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
  • Patients of childbearing potential and sexually active patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or abstaining from sexual intercourse for the duration of their participation in the study and for 6 months after the last dose of protocol treatment. Patients must also not donate sperm while on protocol treatment and for 6 months after the last dose of protocol treatment. Patients must also not breast-feed while on protocol treatment and for 3 months after the last dose of protocol treatment.
  • Patient must not have resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, corrected QT (QTc) prolongation > 500 ms, electrolyte disturbances, etc.) or have congenital long QT syndrome.
  • Concomitant use of known potent CYP3A4/5 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir is prohibited.
  • Patients who are being actively treated for an ongoing concurrent malignancy are ineligible, with the exception of those receiving adjuvant hormone therapies and those receiving topical therapies for skin cancers.
  • Patient must not have, in the opinion of the investigator, any other concurrent medical condition that would prevent the patient from complying with the study procedures.
  • Patient must not be considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.
  • Patient must not have had major surgery within 2 weeks prior to randomization and patients must have recovered from any effects of any major surgery.
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Sex Differences in The Objective Assessment of Frailty in Subjects Undergoing Early Outpatient Cardiac Rehabilitation: A Pilot Study

Sex Differences in The Objective Assessment of Frailty in Subjects Undergoing Early Outpatient Cardiac Rehabilitation: A Pilot Study

Carmen Terzic
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305396-H01-RST
21-007783
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Inclusion Criteria:

  • Adult 18 years and older.
  • English speaking.
  • Able to provide consent.
  • Has a qualifying indication for cardiac rehabilitation (e.g., Acute coronary syndrome, myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting, and stable angina, heart valve disease) and able to participate in cardiac rehabilitation.
  • Olmsted County MN residents. 


Exclusion Criteria:

  • Individuals < 18 years of age.
  • Unwilling to provide consent.
  • Unable to participate in cardiac rehab.

Eligibility last updated 8/13/21. Questions regarding updates should be directed to the study team contact.

 

 

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Optimizing Outcomes of Patients with Advanced HCC Undergoing Immunotherapy Through Novel 68Ga PSMA PET Imaging

A Study Patients with Advanced HCC Undergoing Immunotherapy Through Novel 68Ga PSMA PET Imaging

Nguyen Tran
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-305399-P01-RST
21-007799
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Inclusion Criteria:

  • Patient with pathologically confirmed HCC not amenable to curative resection, transplantation or ablative therapies.
  • Have radiographically measurable disease by RECIST.
  • Eligible for atezolizumab/bevacizumab front line therapy.
  • Male or female with age greater than 18 years, with the capacity and willingness to provide written informed consent.


Exclusion Criteria:

  • Pregnant and/or breast-feeding patients. A negative pregnancy test within 48 hours of the PET scan.
  • Patients with higher than the weight/size limitations of PET/CT scanner.
Behavioral, Drug, Radiation
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Describing the Determinants and Effects of Variation in the Adoption and Use of the NOHARM Pain Management Intervention Among Diverse Surgical Practices

NOHARM Aim 3

Andrea Cheville
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305410-H01-RST
21-007898
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Inclusion Criteria:

  • Participants eligible for this study will be patients on the NOHARM trial registry (e.g., patients that were automatically assigned to receive the NOHARM intervention as part of their surgical care) and/or their charts and members of their care teams, including nurses, doctors, physical therapists, nurse practitioners and physician assistants, and medical assistants.  


Exclusion Criteria:

  • Individuals not on the NOHARM trial registry.

Eligibility last updated 8/13/21. Questions regarding updates should be directed to the study team contact.

 

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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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Cardiolipin Profiling for Barth Syndrome Screening and Characterization (CPfBSSaC)

Cardiolipin Profiling for Barth Syndrome Screening and Characterization

Devin Oglesbee
All
Not specified
This study is NOT accepting healthy volunteers
2021-305433-H01-RST
21-007892
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Inclusion Criteria:

  • Specimens (dried blood spots, whole blood, or retrospectively available cultured cells) from Barth subjects and controls identified by the Barth Syndrome Foundation and/or clinical testing at the Mayo Clinic Biochemical Genetics Laboratory.
  • Residual specimens from the Mayo Clinic Biochemical Genetics Laboratory:
    • Up to 1,000 control subjects from pediatric and adult populations through age 99 on date of relevant specimen collection.
  • Data collected as part of the Barth Syndrome Foundation Registry and Biorepository and/or clinical testing at the Mayo Clinic Biochemical Genetics Laboratory.


Exclusion Criteria:

  • None.

Eligibility last updated 8/13/21. Questions regarding updates should be directed to the study team contact.

 

Genetic disorder
3-Methylglutaconic aciduria type 2
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Effectiveness and Safety of Dexcom Continuous Glucose Monitoring Systems in Non-Critically Ill Patients in the Inpatient Setting

Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring System in Non-Critically Ill Patients in the Inpatient Setting

Yogish Kudva
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305450-P01-RST
21-007993
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Inclusion Criteria:


- 18 years of age and older

- Admitted to the hospital in a non-ICU bed or once transferred out of ICU

- Anticipate at least 48 hours of hospital stay

- On treatment for glucose control.

- Willingness to complete the study.

- Willingness to wear up to 3 CGM systems simultaneously. Two in the abdomen and one on
the back of the arm or one on each arm and one on the abdomen.

- Subject and/or caretaker are able to speak, read, and write English


Exclusion Criteria:


- Presence of extensive skin changes/diseases at sensor wear site(s) that preclude
wearing the sensor(s) on normal skin (e.g., extensive psoriasis, recent burns or
severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis
herpetiformis)

- Currently in an intensive care unit (ICU) of the following type (does not apply to
participants placed in an ICU bed due to space issues in the non-ICU areas)

- Known allergy to medical-grade adhesives

- Pregnancy, demonstrated by a positive test (for subjects of childbearing potential)

- Women admitted to give birth or any other admission related to pregnancy

- Patients receiving Hydroxyurea

- Bleeding disorder

- Participants that are currently being treated for malignancies, cancer

- Participant that are hospitalized to receive an organ transplant

- Require a Magnetic Resonance Imaging (MRI) scan

- End stage renal disease and currently managed by dialysis or anticipating initiating
dialysis during the study wear period

- Current participation in another investigational study protocol (If a subject has
recently completed participation in another drug study, the subject must have
completed that study at least 7 days prior to being enrolled in this study.)

- Any condition that, in the opinion of the Investigator, would interfere with their
participation in the trial or pose an excessive risk to study staff (e.g., known
history of hepatitis B or C)

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

Eligibility last updated 1/23/23. Questions regarding updates should be directed to the study team contact

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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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A Phase III, Prospective, Open-Label, Randomized Clinical Trial Evaluating the Augmenting of Anti-SARS-CoV2 Immunity in Kidney Transplant Recipients via Heterologous Prime Booster Vaccination with Janssen Ad26.CoV2.S vaccine

J&J Vaccine Booster in Transplant Recipients

Mark Stegall
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-305460-H01-RST
21-008036
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Inclusion Criteria:


Criteria for Entry into the Study:

- Any kidney transplant recipient from Mayo Clinic who has received the mRNA vaccine
(two or three dose mRNA vaccine-Moderna or Pfizer) and are >28 days after most recent
vaccination at the time of spike protein assessment.

- Recipients of a kidney transplant, including those transplanted with other solid organ
transplants in addition to the kidney. Subjects may have received more than 1 kidney
transplant.

- More than 90 days since any transplant including a kidney transplantation. ?≥18 years
of age on the day of consent.

Criteria for Entry into Segment I

- Must have a Roche Elecsys® Anti-SARS-CoV-2 S level of <250 U/mL to be eligible for
Segment I.

- Platelet count of >75,000/µL on the day of vaccination with the Janssen Ad26.CoV2.S
vaccine.

- Contraceptive (birth control) use should be consistent with local regulations
regarding the acceptable methods of contraception for those participating in clinical
studies.

- Before randomization, participants must be either:

- Not be of childbearing potential

- Of childbearing potential and practicing an acceptable effective method of
contraception. Subject must agree to remain on contraception from date of consent
until 3 months after the last dose of the Janssen Ad26.CoV2.S vaccine. Use of
hormonal contraception should start at least 28 days before the 1st
administration of the Janssen Ad26.CoV2.S vaccine. The sponsor-investigator
should evaluate the potential for contraceptive method failure (for example,
noncompliance, recently initiated) in relationship to the Janssen vaccination.
Acceptable effective method a for this study include:

- Hormonal contraception:

- Combined (estrogen and progestogen containing) hormonal contraception associated with
inhibition of ovulation (oral, intravaginal, or transdermal)

- Progestogen-only hormonal contraception associated with inhibition of ovulation (oral,
injectable, or implantable)

- Intrauterine device

- Intrauterine hormone-releasing system

- Bilateral tubal occlusion/ligation procedure

- Vasectomized partner (the vasectomized partner should be the sole partner for
that participant)

- Sexual abstinence (defined as refraining from heterosexual intercourse from the
date of consent until 3 months after the last dose of the Janssen Ad26.CoV2.S
vaccine. The reliability of sexual abstinence needs to be evaluated in relation
to the duration of the study and the preferred and usual lifestyle of the
participant.). Note: Use of condoms is not considered as an acceptable
contraceptive barrier method due to the failure rate of female and male condoms
(Centers for Disease Control and Prevention. Reproductive Health: Contraception.
https://www.cdc.gov/reproductivehealth/contraception/index.htm. Accessed 23
November 2020)

- If subject is female and of childbearing potential, she must:

- Have a negative highly sensitive serum pregnancy test prior to vaccination.

- Participant agrees to not donate bone marrow, blood, and blood products from the first
Janssen Ad26.CoV2.S vaccine administration until 3 months after the last dose of the
Janssen Ad26.CoV2.S vaccine.


Exclusion Criteria:


- Clinically significant acute illness (this does not include minor illnesses such as
diarrhea or mild upper respiratory tract infection) or temperature ≥38.0ºCelsius (C)
(100.4°Fahrenheit [F]) within 24 hours prior to the planned 1st dose of the Janssen
Ad26.CoV2.S vaccine; randomization at a later date is permitted at the discretion of
the sponsor-investigator.

- Has a known or suspected allergy or history of anaphylaxis or other serious adverse
reactions to vaccines or their excipients (including specifically the excipients of
the Janssen Ad26.CoV2.S vaccine; refer to the Investigative Brochure).

- Subject has received or plans to receive:

- Licensed live attenuated vaccines -within 28 days before or after planned
administration of the 1st or subsequent Janssen vaccinations.

- Other licensed (not live) vaccines -within 14 days before or after planned
administration of the 1st or subsequent Janssen vaccinations.

- Received an investigational drug within 30 days (including investigational drugs for
prophylaxis of COVID-19) or used an invasive investigational medical device within 30
days of the Janssen Ad26.CoV2.S vaccine. Received investigational Ig or
investigational monoclonal antibodies within 3 months, or received convalescent serum
for COVID-19 treatment within 4 months or received an investigational vaccine
(including investigational Adenoviral- vectored vaccines) within 6 months before the
planned administration of the 1st dose of the Janssen Ad26.CoV2.S vaccine or is
currently enrolled or plans to participate in another investigational study within 3
months after the last Jansen vaccination.

Note: Participation in an observational clinical study is allowed at the
sponsor-investigator's discretion; please notify the sponsor-investigator of this decision.
Efforts will be made to ensure inclusion of participants who have not been previously
enrolled in coronavirus studies. In order to participate subject must agree and understand
that they cannot enroll in other coronavirus focused studies while participating in this
one.

- Is pregnant or planning to become pregnant at the time of consent and within 3 months
of the last dose of the Janssen Ad26.CoV2.S vaccine.

- Has a history of an underlying clinically significant acute or chronic medical
condition or physical examination findings which, in the opinion of the
sponsor-investigator, would make study participation not be in the participant's best
interest (e.g., compromise the well- being) or that could prevent, limit, or confound
the protocol-specified assessments.

- Has a contraindication to Intramuscular (IM) injections and blood draws.

- Has had major psychiatric illness, which in the sponsor-investigator's opinion would
compromise the participant's safety or compliance with the study procedures.

- Cannot communicate reliably with the sponsor-investigator or comply with study
procedures.

- In the opinion of the sponsor-investigator, is unlikely to adhere to the requirements
of the study or is unlikely to complete the full course of protocol required
vaccination and observation.

- History of cancer malignancy within 1 year before screening (exceptions are squamous
and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or other
malignancies with minimal risk of recurrence).

- History of acute polyneuropathy (e.g., Guillain-Barré syndrome)

- Chronic history of platelet count <75,000/µL.

- History of thrombosis with thrombocytopenia syndrome (TTS) or heparin-induced
thrombocytopenia (HIS).

- History of capillary leak syndrome (CLS).

- Received pre-exposure prophylactic medications for COVID-19 that could interfere with
assessments of any study-related endpoint

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

Eligibility last updated 9/20/22. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine
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Decreasing Delirium Through Music in Critically Ill Older Adults (DDM)

Decreasing Delirium in Critically Ill Older Adults Through Music

Linda Chlan
All
50 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-305465-P01-RST
21-008206
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Inclusion Criteria:

  • Age 50 years or older.
  • English speaking.
  • Admitted to the intensive care unit (medical or surgical).
  • Expected mechanical ventilator support for ≥ 48 hours.
  • Consentable through a legally authorized representative.
  • Have access to a telephone (after discharge).


Exclusion Criteria:

  • History of dementing illnesses and other neurodegenerative diseases such as Alzheimer’s disease or vascular dementia.
  • Psychiatric illness which is not well controlled.
  • Alcohol withdrawal symptoms/concern for withdrawal.
  • Suspected or confirmed drug intoxication/overdose.
  • Traumatic brain injury, ischemic or hemorrhagic cerebrovascular accident, or undergoing neurosurgery.
  • Uncorrected hearing or vision impairment including legal blindness.
  • Incarcerated at the time of study enrollment.
  • Enrolled in another clinical trial which does not permit co-enrollment.
  • Any medical condition precluding safe use of headphones such as:  skin breakdown, burns, facial or skull fractures.
  • COVID-19 positive test.
Behavioral, Other
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A Randomized, Double-blind, Placebo-controlled, Dose-escalation Study Evaluating the Safety and Efficacy of Two Doses of Duloxetine & Amitriptyline in Subjects with Refractory Chronic Cough (MACS-01)

Efficacy of Two Doses of Duloxetine and Amitriptyline in Subjects With Refractory Chronic Cough (MACS-1)

Vivek Iyer
All
18 years to 85 years old
Not Applicable
This study is NOT accepting healthy volunteers
2021-305482-H01-RST
21-008116
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Inclusion Criteria:

  • Women and men between 18 and 85 years of age.
  • Chest radiograph or computed tomography (CT) of the thorax within the last 1 year not demonstrating any abnormality considered to be significantly contributing to the refractory chronic cough in the opinion of the Principal Investigator.
  • Have a diagnosis of refractory chronic cough or unexplained cough for at least one year.
  • Have a score of ≥ 40mm on the Cough Severity VAS at Screening.
  • Women of child-bearing potential (defined in supplemental section 1, page 64) must agree to use 2 forms of acceptable birth control and make no donation of eggs from Screening through the end of the 8-week study period. Acceptable birth control methods include established use of oral, injected, or implanted hormonal methods of contraception; intrauterine device (IUD) or intrauterine system (IUS); tubal ligation; or male sterilization. Double-barrier method (diaphragm for female subject and condom for male partner with spermicidal) satisfies the requirement for 2 forms of acceptable birth control. When concordant with the preferred lifestyle of the subject, true and complete abstinence (not periodic abstinence) is acceptable.
  • Male subjects and their partners of child-bearing potential must use 2 methods of acceptable birth control, 1 of which must be a barrier method, and make no donation of sperm from Screening until 3 months after the last dose of study drug at the end of 8 weeks.
  • Have provided written informed consent.
  • Are willing and able to comply with all aspects of the protocol.


Exclusion Criteria:

  • Current smoker (cigarettes, e-cigarettes or marijuana) or former smokers who have smoked within the past 12 months.
  • Former smokers with > 20 pack-year history of smoking.
  • Ongoing treatment with an ACE-inhibitor that is considered as the potential cause of a subject’s cough or requiring treatment with an ACE-inhibitor during the study or within 12 weeks prior to the Screening/Baseline Visit (Day -14 to Day 0).
  • FEV1/FVC < 60%.
  • History of upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Screening/Baseline Visit (Day -14 to Day 0).
  • History of opioid use specifically prescribed for chronic cough within 2 weeks of the Screening/Baseline Visit (Day -14 to Day 0). Use of opioids for other indications (for example, to treat pain) is permitted.
  • History of baclofen use specifically prescribed for chronic cough within 2 weeks of the Screening/Baseline Visit (Day -14 to Day 0). Use of baclofen for other indications (for example, to treat spasticity) is permitted.
  • Diagnosis of COPD, bronchiectasis, interstitial lung disease or cystic fibrosis.
  • Presence of an untreated or undertreated cause for the patient’s chronic cough (as determined by the treating/referring physician per ACCP guidelines). e.g. uncontrolled asthma, GERD or post-nasal drainage that could potentially explain the patient’s chronic cough.
  • Requiring concomitant therapy with prohibited medications (see under ‘prohibited concomitant therapy’ on page 28).
  • Treatment with any pharmaceutical or biological investigational therapy (excluding coronavirus disease of 2019 (COVID) vaccination and COVID related monoclonal antibody therapy).
  • Participation in another clinical trial that does not allow co-enrollment within 4 weeks prior to the Screening/Baseline Visit (Day -14 to Day 0).
  • Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 x the upper limit of normal (ULN) during screening.
  • Serum creatinine < 30 mL/min, hemodialysis or peritoneal dialysis.
  • Advanced liver disease as defined by the presence of cirrhosis and/or signs of portal hypertension.
  • History of previous hypersensitivity or intolerance to Duloxetine & Amitriptyline (patients who have previously been on either amitriptyline or duloxetine for chronic cough or other reasons and have tolerated the medication will be offered participation regardless of previous response to therapy).
  • Currently pregnant or breastfeeding female subject.
  • Presence of any medical condition or disability that the investigators believe could interfere with the assessment of safety or efficacy in this trial or compromise the safety of the subject.
  • Planned or anticipated major surgical procedure or other activity that would interfere with the subject’s ability to comply with protocol-mandated assessments (e.g., extended travel) during the subject’s participation in the study.
  • Currently taking either another SSRI, SNRI or MAO inhibitor which the patient cannot safely discontinue at least 2 weeks prior to the screening period.

Eligibility last updated 4/15/22. Questions regarding updates should be directed to the study team contact.

Drug, Other
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Clinical Utility of the Addition of a SNP-based NIPT Zygosity Determination in TWIN Pregnancy Management (ZTWINS) (ZTWINS)

Clinical Utility of the Addition of a SNP-based NIPT Zygosity Determination in TWIN Pregnancy Management

Myra Wick
All
0 years to 55 years old
This study is NOT accepting healthy volunteers
2021-305487-P01-RST
21-008126
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Inclusion Criteria:

  • Female patients age 18 at the time of signing informed consent, up to 55 years of age.
  • Ultrasound confirmation of twin pregnancy no later than 20 weeks gestational age (GA), and prior to Panorama.
  • Panorama planned no later than 20 weeks GA.
  • Willing and able to provide written informed consent.
  • Willing and able to comply with institution’s standard of care prenatal procedures, including ultrasound assessments and Panorama.
    • Note: subjects with known major congenital anomalies, known unbalanced chromosomal complement or ruptured membranes, may be enrolled in the study.


Exclusion Criteria:

  • Singleton or non-twin multiple pregnancy.
  • Ultrasound confirmation of twin pregnancy at 20 weeks 1 day GA or later.
  • Patient has received a Panorama test and the enrolling physician has received the Panorama test results prior to any ultrasound assessment of chorionicity & amnionicity.
  • Panorama testing is planned at 20 weeks 1 day GA or later.
  • Any confounding complication or condition that, in the opinion of the investigators, precludes participation in the study, such as evidence of TTTS or other monochorionic pregnancy complication already at the time of enrollment.
  • Unwilling or unable to participate in the institution’s standard of care prenatal ultrasound and/or testing with Panorama.
  • Unwilling or unable to provide written informed consent.

Eligibility last updated 4/26/22. Questions regarding updates should be directed to the study team contact.

 

 

Prenatal care, Antepartum care, Reproductive system, Twin pregnancy
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Novel Antiaging Regenerative Skin Care Regimen Containing Human Platelet Extract (HPE) (POSH)

Aesthetic Study: A New Regenerative Skin Care Regimen Containing Human Platelet Extract

Saranya Wyles
All
18 years to 85 years old
This study is NOT accepting healthy volunteers
2021-305490-H01-RST
21-008529
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Inclusion Criteria:

  • Adult males and females, ages 40 to 85 years.
  • Persons of childbearing potential must have a negative pregnancy test prior to receiving the study drug and will agree to use adequate contraception (hormonal or barrier method or abstinence) from the time of screening to a period of 2 years until discontinuation of treatment. Females of childbearing potential are defined as premenopausal and not surgically sterilized, or post-menopausal for fewer than 2 years. A urine pregnancy test will be performed prior to the administration of the study drug to confirm negative results. If the urine pregnancy test is positive, the study drug will not be administered, and the result will be confirmed by a serum pregnancy test. Urine pregnancy tests will be performed by qualified personnel using kit.  Persons becoming pregnant during the study will continue to be monitored for the duration of the study or completion of the pregnancy, whichever is longer. Monitoring will include perinatal and neonatal outcome. Any SAEs associated with pregnancy will be recorded.
  • All skin phototypes ≥ grade I of Fitzpatrick’s classification.
  • Mild-to-moderate global face wrinkles and mild-to-moderate global fine lines based on a modified Griffiths’ 10-point scale.
  • Fully understanding of the requirements of the study and willingness to comply with the treatment plan, including laboratory tests, diagnostic imaging, and follow-up visits and assessments.
  • Volunteer willingness to discontinue any other anti-aging topical or parenteral treatments for the duration of the study.
  • Can provide written informed consent and complete HIPAA documentation after the nature of the study is fully explained and prior to any study-related treatment.
  • Can provide written informed consent to being photographed for purposes of treatment for medical, scientific purposes.


Exclusion Criteria:
 

  • Pregnant or nursing, or planning on becoming pregnant during the study period.
  • Subjects who have had an antiaging or esthetic treatment prior to the study: Botox or Botox‐like products, peelings, plastic surgery, resurfacing with Laser, IPL, threats, radiofrequency treatments, hyaluronic acid treatment, Plasma‐Rich Platelets treatment, or any other specific treatments prone to change the skin aspect during the last 6 months.
  • Individuals with a history of any dermatological disease or condition, including but not limited to active atopic dermatitis, psoriasis, eczema, active seasonal allergies, collagen diseases, or skin cancer involving the treated sites within the past 6 months.
  • Cutaneous marks on the experimental area which could interfere with the assessment of skin reactions (pigmentation problems, scar elements, over‐developed pilosity, ephelides, and nevi in too great quantity, sunburn, beauty spots, freckles, etc.).
  • Participants with asymmetric photodamage on dorsal hands due to environmental exposures (i.e., golfing) and/or other skin lesions including burns or scars resulting in significant skin surface variability between dorsal hands.
  • Eczematous reaction still visible, scar, or pigmentary sequelae of previous tests on the experimental area.
  • Allergy to colophony or nickel.
  • Allergy or reactivity to drugs, food or cosmetic products previously observed, including perfumes or cologne products.
  • Skin hyper‐reactivity.
  • Forecast of intensive sun, tanning bed use or UV phototherapy during the test period.
  • Treatment with Vitamin A acid or its derivatives within 3 months before the beginning of the study.
  • Treatment with topical corticoids on the experimental area within 16 days before the study.

Eligibility last updated 2/24/22. Questions regarding updates should be directed to the study team contact.

 

 

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(ECTx) C4401001 / A Phase I Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of PF-07257876 in Patients with Advanced or or Metastatic Tumors (C4401001)

Study to Test the Safety and Tolerability of PF-07257876 in Participants with Selected Advanced Tumors

Saravut Weroha
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2021-305495-P01-RST
21-008170
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Inclusion Criteria:

  • Participants ≥ 18 years old at the screening visit.
  • Histological or cytological diagnosis of advanced/metastatic NSCLC (regardless of subtype) or SCCHN meeting the following criteria:
    • Receipt of exactly 1 prior treatment regimen with a PD-1 or PD-L1 therapy, with or without chemotherapy (in combination or sequentially), in the advanced/metastatic disease setting;
    • No prior immunologic therapy may have been given other than anti-PD-1/PD-L1;
    • Prior chemotherapy is not required; participants may have received up to 2 prior chemotherapy regimens;
    • NSCLC Only: Most recent treatment must have included anti-PD-1/PD-L1 therapy;
    • Prior anti-PD-1/PD-L1 therapy must not have been permanently discontinued due to toxicity.
  • Confirmed radiographic progression of disease must have occurred within the following timeframes:
    • NSCLC: After at least 12 weeks of therapy, during which time the participant had a best response of either CR, PR, or SD (the SD must be >12 weeks). Note: Participants with “pseudo-progression” within this 12-week time period are eligible to enter the study. Pseudo-progression must be decided upon by the investigator, followed by a discussion with the sponsor;
    • SCCHN: After at least 6 weeks of therapy, during which time the participant had a best response of either CR, PR, or SD (SD must be > 6 weeks);
    • NSCLC Only: Confirmed radiographic disease progression must have occurred within < 12 weeks after the last dose of the anti-PD-1/PD-L1 therapy;
    • PD-L1 IHC positivity ≥1% (regardless of CoDx™ assays).
  • At least 1 measurable lesion, as defined by RECIST version 1.1, which has not been irradiated previously.
  • Ovarian cancer.
  • Histologically confirmed epithelial ovarian, fallopian tube, or peritoneal cancer, including malignant mixed Müllerian tumors with high-grade serous component.
  • Platinum-resistant/refractory disease, defined as disease progression within 6 months following the last administered dose of platinum therapy (resistant), or lack of response or disease progression while receiving the most recent platinum-based therapy (refractory), respectively.
  • May have received up to 3 lines of systemic anticancer therapy for platinum-sensitive disease, most recently platinum-containing, and no prior systemic therapy for platinum-resistant or refractory disease. (Note: Receipt of maintenance PARP inhibitor after platinum-containing therapy does not change this criteria). Prior therapy with chemotherapy + bevacizumab for platinum resistant disease is not required.
  • At least 1 measurable lesion, as defined by RECIST version 1.1, that has not been previously irradiated.
  • Must not have received prior anti-PD-1/PD-L1 therapy.
  • PD-L1 IHC positivity ≥ 1% (regardless of CoDx™ assays).
  • ECOG PS 0 or 1.
  • Estimated life expectancy of at least 3 months.
  • Adequate Bone Marrow Function, including:
    • ANC > 1,500/mm^3 or >1.5 x 10^9/L;
    • Platelets > 100,000/mm^3 or >100 x 10^9/L;
    • Hemoglobin >10 g/dL;
  • Adequate Renal Function including:
    • Estimated creatinine clearance ≥ 30 mL/min as calculated using the
      Cockroft-Gault method. In equivocal cases, a 24-hour urine collection test can
      be used to estimate the creatinine clearance more accurately.
  • Adequate Liver Function, including:
    • Total serum bilirubin < 1.5 x ULN;
    • AST and ALT < 2.5 x ULN;
    • < 5.0 x ULN if there is liver involvement by the tumor;
    •  Alkaline phosphatase < 2.5 x ULN (< 5 x ULN in case of bone metastasis).
  • Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤ 1 except for AEs not constituting a safety risk by investigator judgment.
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  • Participants in Part 1 must have recently obtained archival tumor tissue available (collected within 6 months prior to screening) for submission to the sponsor. Participants should have access to formalin-fixed paraffin embedded material containing tumor that is of diagnostic quality and representative of their diagnosed malignancy. If archival sample is older than 6 months, the patient must consent to undergo a de novo biopsy during the screening period. If a new biopsy represents a significant safety risk that can be documented specifically by the Investigator using medical reports, radiographs, or other materials that outline the exact risk involved, the patient may be considered for enrollment, after discussion of the risk with the sponsor.
  • Participants enrolled in the RP2D safety expansion cohort of Part 1 must have a tumor amenable to biopsy and consent to the mandatory paired de novo pretreatment and on-treatment biopsy procedures.
  • All participants in Part 2 must have a tumor amenable to biopsy and consent to undergo a de novo biopsy during screening. Participants entering the study in the subgroup(s) requiring mandatory on-treatment tumor biopsy must consent to these planned biopsy procedures.


Exclusion Criteria:

  • Participants with the finding of any new brain metastases detected by mandatory screening MRI are excluded. Participants may be re-screened for study entry under the following conditions:
    • if the Investigator deems their clinical status acceptable for participation in the trial;
    • all other inclusion and exclusion criteria are  satisfied;
    • corticosteroid treatment for these metastases has been discontinued for at least 4  weeks prior to study entry;
    • neurologically stable by examination and MRI for at least 3 months; 
    • do not require initiation or an increase in anti- epileptic medication for at least 4 weeks prior to start of study treatment; and
    • after discussion with the sponsor. 
    • Note: At the discretion of the sponsor based upon safety findings, screening and on-study MRIs may be removed for all participants during dose escalation.
  • Participants with at least one known brain metastasis larger than 4 cm in longest diameter, or with any known brain metastasis that is symptomatic.
  • Participants with previously diagnosed brain metastases are eligible if they have completed their treatment, recovered from the acute effects of radiation therapy or surgery prior to study entry (Day 1), and meet the following criteria
    • if the Investigator deems their clinical status acceptable for participation in the trial;
    • all other inclusion and exclusion criteria are satisfied;
    • corticosteroid treatment for these metastases has been discontinued for at least 4 weeks prior to study entry;
    • neurologically stable by examination and MRI for at least 3 months;
    • do not require initiation or an increase in anti-epileptic medication for at least 4 weeks prior to start of study treatment; and
    • after discussion with the sponsor.
  • Participants with abnormal neurologic examination by the investigator.
  • Participants with any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ. Participants with a history of other curatively treated cancers may be eligible, after discussion and review by the sponsor.
  • Non-epithelial tumor or ovarian tumor with low malignant potential (i.e., borderline tumors).
  • Known or suspected hypersensitivity to PF-07257876 components.
  • Major surgery within 4 weeks prior to planned first dose.
  • Radiation therapy with treatment intent within 4 weeks prior to study entry. Any palliative radiation therapy must be completed within the 7 days prior to C1D1.
  • Irradiation to > 25% of the bone marrow.
  • Active bleeding disorder, including gastrointestinal bleeding, as evidenced by hematemesis, significant hemoptysis, or melena in the past 6 months.
  • History of Grade ≥ 3 immune-mediated AE (including AST/ALT elevations that where considered drug-related and CRS) that was considered related to prior immune modulatory therapy (e.g., immune CPIs, costimulatory agents, etc) and required immunosuppressive therapy. Participants with immune-mediated endocrinopathies controlled with hormonal replacement therapy (e.g., thyroid disorders, diabetes, adrenal insufficiency) are eligible.
  • History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic
    organizing pneumonia), evidence of active pneumonitis on screening chest CT scan.
    • Note: A history of radiation pneumonitis (localized pulmonary fibrosis) in the field of prior radiation therapy is not exclusionary.
  • Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.

Eligibility last updated 8/16/21. Questions regarding updates should be directed to the study team contact.

 

 

Biologic/Vaccine
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MC210705 Phase 1 Study of the Administration of STI-3031 (anti-PDL1) Intra-Lymphatically Using the Sofusa® DoseConnect™ DEVICE in Patients with In-Transit Melanoma (Sofusa 2)

STI-3031 Through Sofusa DoseConnect for Treatment of Intransit Melanoma

Anastasios Dimou
All
18 years and over
Phase 1, Feasibility
This study is NOT accepting healthy volunteers
2021-305509-P01-RST
21-010150
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Registration –

Inclusion Criteria:

  • Age ≥ 18 years.
  • Newly diagnosed, recurrent, or previously treated in-transit metastatic melanoma (ITM) confined to a single limb.
  • Regional involvement of the inguinal (lower limb) and axillary (upper limb) lymph nodes is permitted.
  • One of the following must be true:
    • A visible superficial ITM, non-nodal lesion with longest diameter ≥ 0.2 cm in diameter as assessed using a ruler (e.g., skin nodules). Documentation by color photography, including a ruler is required;
    • A malignant regional lymph node with short axis > 1.0 cm as assessed by CT scan (CT scan slice thickness recommended to be no greater than 5 mm);
    • A non-visible, non-nodal soft tissue mass of the involved extremity with longest diameter ≥1.0 cm as measured with CT scan, CT component of a PET/CT, or MRI.
  • The following laboratory values obtained ≤ 15 days prior to registration:
    • Hemoglobin ≥ 8.0 g/dL;
    • Absolute neutrophil count (ANC) ≥ 1500/mm^3;
    • Platelet count ≥ 75,000/mm^3;
    • Total bilirubin ≤ 1.5 × ULN;
    • Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3.0 × ULN;
    • Serum creatinine ≤ 2.0 × ULN;
    • Calculated creatinine clearance ≥ 40 ml/min using the Cockcroft-Gault formula;
    • PT/INR/aPTT ≤ 1.5 × ULN
      OR if patient is receiving anticoagulant therapy INR or aPTT is within target range of therapy.
  • ECOG Performance Status (PS) 0 or 1.
  • Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only.
  • Persons able to become pregnant OR able to father a child must be willing to use an adequate method of contraception while on treatment and for 180 days (6 months) after last treatment dose on this study.
  • Provide written informed consent.
  • Willingness to provide mandatory blood specimens for correlative research.
  • Willing to return to enrolling institution for 3-month follow-up (during the Active Monitoring Phase of the study).

Registration


Exclusion Criteria:

  • Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown:
    • Pregnant persons;
    • Nursing persons;
    • Persons of childbearing potential who are unwilling to employ adequate contraception;
    • Persons expecting to conceive or father children during the study or within 180 days (6 months) after the last treatment on this study.
  • Metastatic melanoma beyond in-transit metastases (ITM) and regional lymph nodes (LNs).
  • ITM involving the hands and feet (not accessible to DoseConnect infusion).
  • ITM NOT involving a limb (i.e., head, neck, or trunk).
  • Prior radiation of ITM that are being evaluated as measurable lesions.
  • Any of the following prior therapies:
    • Allogeneic hematopoietic stem cell transplantation (HSCT);
    • Solid organ transplantation.
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy.
    • NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
  • Active autoimmune disease requiring systemic treatment < 2 years prior to registration, documented history of severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents with use of disease modifying agents, corticosteroids, or immunosuppressive drugs.
    • NOTE: Exceptions are allowed for the following conditions:
    • Vitiligo;
    • Resolved childhood asthma/atopy;
    • Intermittent use of bronchodilators or inhaled steroids;
    • Daily steroids at dose of ≤ 10mg of prednisone (or equivalent);
    • Local steroid injections;
    • Stable hypothyroidism on replacement therapy;
    • Stable diabetes mellitus on therapy (with or without insulin);
    • Sjögren’s syndrome;
    • Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) which is not considered a form of systemic treatment and is allowed.
  • Uncontrolled intercurrent illness including, but not limited to:
    • Ongoing or active infection requiring systemic therapy;
    • Interstitial lung disease;
    • Serious, chronic gastrointestinal conditions associated with diarrhea (e.g., Crohn’s disease or others);
    • Known history of hepatitis B (i.e., known positive HBV surface antigen (HBsAg) reactive);
    • Known active hepatitis C (i.e., positive for HCV RNA detected by PCR);
    • Known active tuberculosis (TB);
    • Symptomatic congestive heart failure;
    • Unstable angina pectoris;
    • Unstable cardiac arrhythmia; or
    • Psychiatric illness/social situations that would limit compliance with study requirements (e.g., known substance abuse).
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
  • History of severe hypersensitivity reactions to other monoclonal antibodies or known hypersensitivity to the study intervention or its excipients, indocyanine green (ICG) dye or iodine.
  • Prior history of Grade 4 immune related adverse event (irAE) with prior ICI therapy or failure to recover (< Grade 1) from immune-related adverse event(s) from prior ICI therapy.
  • Any of the following therapies prior to registration:
    • Chemotherapy ≤ 21 days;
    • Immunotherapy ≤ 21 days;
    • Targeted therapies (e.g., dabrafenib) ≤ 21 days;
    • Other investigational agents ≤ 28 days;
    • Radiation therapy ≤ 14 days;
    • Minor surgical or interventional procedure ≤ 7 days, (biopsy of same limb for diagnosis allowed);
    • Major surgical procedure ≤ 21 days.

Eligibility last updated 12/17/21. Questions regarding updates should be directed to the study team contact.

Combination Product, Device, Drug
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An International, Non-Drug Interventional, Real-world Cohort of PAH Patients Newly Initiating PAH Therapy With Guideline-directed Assessments of Disease Severity (CARE PAH)

A Study of Real-world Cohort of Pulmonary Arterial Hypertension (PAH) Participants

Hilary DuBrock
All
18 years and over
Phase 4
This study is NOT accepting healthy volunteers
2021-305513-P01-RST
21-008200
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Inclusion Criteria:


- Symptomatic pulmonary arterial hypertension (PAH) in any PAH subtype

- PAH diagnosis confirmed by hemodynamic evaluation at rest at any time prior to or at
the index date fulfilling all of the criteria below: a) Mean pulmonary artery pressure
greater than (>) 20 millimeters of mercury (mm Hg), and b) Pulmonary artery wedge
pressure or left ventricular end diastolic pressure less than or equal to (<=) 15 mm
Hg, and c) Pulmonary vascular resistance greater than or equal to (>=) 3 Wood Units
(that is, >= 240 dynes seconds per centimeters penta [dyn?sec/cm^5])

- Participant satisfies either a or b: a) Newly initiating 1 or more PAH therapy(ies)
(as monotherapy or add-on therapy) at index date. These newly initiated PAH therapies
should not have been used within 3 months of the index date; b) Taking macitentan 10
milligrams (mg) therapy (as monotherapy or in combination) with no changes in PAH
therapy for within 3 months prior to the index date

- All mandated assessments must be performed and recorded at the baseline visit before
the initiation of the new PAH therapy at the index date or enrollment in the study.

- For the pulmonary arterial hypertension-symptoms and impact (PAH-SYMPACT) substudy
only: Participants initiating any endothelin receptor antagonist (ERA) or
phosphodiesterase-5 inhibitor therapies at index date or at therapy change must
provide consent to enroll in the optional PAH-SYMPACT substudy. Refusal to give
consent for the optional PAH-SYMPACT substudy will not exclude a participant from
participation in the main study


Exclusion Criteria:


- Participants enrolled in any interventional clinical trial with an investigational
therapy in the 3-month period prior to index date

- Currently enrolled in an observational study sponsored or managed by a Janssen company

- Presence of moderate or severe obstructive lung disease (forced expiratory volume in 1
second [FEV1] / forced vital capacity [FVC] <70%; and FEV1 <60% of predicted after
bronchodilator administration) in participants with a known or suspected history of
significant lung disease, as documented by a spirometry test performed within 1 year
prior to screening

- Presence of moderate or severe restrictive lung disease (for example, total lung
capacity or FVC <60 percent [%] of normal predicted value) in participants with a
known or suspected history of significant lung disease, as documented by a spirometry
test performed within 1 year prior to screening

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

Eligibility last updated 7/27/22.  Questions regarding updates should be directed to the study team contact.

Drug
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Genetic Risk and Cancer Estimation (GRACE) Study (GRACE)

Genetic Risk and Cancer Estimation Study

Fergus Couch
All
18 years to 90 years old
This study is NOT accepting healthy volunteers
2021-305522-H01-RST
21-008216
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Inclusion Criteria:

  • Eligible particiants between the ages of 18 and 90.
  • Either a family or personal history of cancer and/or a family or personal history of genetic variants in cancer predisposition genes.
  • Participants may also be those who have tested negatively for genetic variants in cancer predisposition genes.


Exclusion Criteria:

  • This project does not involve prisoners or children.

Eligibility last updated 8/16.21. Questions regarding updates should be directed to the study team contact.

 

 

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BONAPH1DE, A prospective observational study of patients with primary hyperoxaluria type 1 (PH1) (ALN-GO1-007)

BONAPH1DE

John Lieske
All
Not specified
This study is NOT accepting healthy volunteers
2021-305536-P01-RST
21-008615
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Inclusion Criteria:

  •  Documented diagnosis of PH1, per physician’s determination.
  • Written patient consent (per local regulations or ethics committee requirements) obtained prior to enrollment. If the patient is under the age of legal consent, written consent must be obtained from their legal guardian, and the patient should provide assent per local and national requirements. Should they become adults during their participation in the study, they will review and sign the adult consent, as applicable. Consent may be obtained from a legal representative if required and permitted by country-specific regulations or requirements.


Exclusion Criteria:

  • Currently enrolled in a clinical trial for any investigational agent.
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Verification of Risk Assignment for Whole Chromosome Aneuploidy using SNP-based NIPT in VaniSHing Twin Pregnancies (VANISH) (VANISH)

Verification of Risk Assignment for Whole Chromosome Using SNP-based NIPT in Vanishing Twin Pregnancies (VANISH)

Myra Wick
All
0 years and over
This study is NOT accepting healthy volunteers
2021-305547-P01-RST
21-008302
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Inclusion Criteria:

  • Female age 18 or older at the time of signing informed consent.
  • Ultrasound confirmation of singleton pregnancy.
  • GA ≥ 9 weeks at the time of first sample collection.
  • Willing and able to provide written informed consent.
  • Willing and able to comply with study procedures, including blood sample and neonatal buccal swab.
  • Cohort 1: Ultrasound confirmation of VT Pregnancies:
    • Ultrasound confirmation of VT;
    • Spontaneous fetal demise of one twin or empty sac.
  • Cohort 2: High Risk for VT Pregnancies:
    • Panorama yielding “high risk for twin/VT/triploidy” result;
    • Ultrasound confirmation of single gestation;
    • No evidence of triploidy.


Exclusion Criteria:

  • Known monozygotic twin pregnancy.
  • Multiple gestation.
  • VT pregnancy resulting from iatrogenic fetal demise.
  • GA < 9 weeks.
  • Evidence of triploidy other than Panorama test results.
  • Any confounding complication or condition that, in the opinion of the investigators, precludes participation in the study; this may include a cancer diagnosis, organ transplant, pregnancy utilizing an egg donor, or other findings that may interfere with interpretation of Panorama results.

Eligibility last updated 10/19/21. Questions regarding updates should be directed to the study team contact.

Miscarriage, Multiple gestation
Reproductive system, Vanishing twin syndrome
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Location Contacts
Mayo Clinic — Rochester, MN

D8534C00001 SERENA-6: A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor (Palbociclib or Abemaciclib) vs Continuing Aromatase Inhibitor (Letrozole or Anastrozole)+ CDK4/6 Inhibitor in HR+/HER2-MBC Patients With Detectable ESR1Mutation Without Disease Progression During 1L Treatment With Aromatase Inhibitor+ CDK4/6 Inhibitor- A ctDNA Guided Early Switch Study (SERENA-6)

Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)

Matthew Goetz
All
18 years to 130 years old
Phase 3
This study is NOT accepting healthy volunteers
2021-305549-P01-RST
21-010873
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Inclusion Criteria:


- Proven diagnosis of adenocarcinoma of the breast with evidence of locoregionally
recurrent or metastatic disease not amenable to resection or radiation therapy with
curative intent.

- Documentation of histologically confirmed diagnosis of estrogen receptor positive
(ER+) /HER2- breast cancer based on local laboratory results.

- Currently on AI (letrozole or anastrozole) + CDK4/6 inhibitor (palbociclib or
abemaciclib) ± LHRH as the initial endocrine based treatment for advanced disease

- Eastern Cooperative Oncology Group performance status of 0 or 1.

- ESR1m positive detected by central testing of ctDNA

- Willingness and ability to comply with scheduled visits, treatment plan, laboratory
tests, and other study procedures.

- Adequate organ and marrow function


Exclusion Criteria:


- Advanced, symptomatic, visceral spread, that are at risk of life-threatening
complications in the short term.

- Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or
leptomeningeal disease.

- Any evidence of severe or uncontrolled systemic diseases which, in the investigator's
opinion, makes it undesirable for the participant to participate in the study or that
would jeopardize compliance with the protocol.

- Patient with known or family history of severe heart disease

- Previous treatment with AZD9833, investigational SERDs or fulvestrant.

- Currently pregnant (confirmed with positive pregnancy test) or breastfeeding.

- Persistent non-haematological toxicities (CTCAE Grade > 2) caused by CDK4/6 inhibitor
and/or AI treatment.

 

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

Eligibility last updated 9/21/22. Questions regarding updates should be directed to the study team contact.

Drug
I'm interested
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Location Contacts
Mayo Clinic — Rochester, MN