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3289 Study Matches

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A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase 3 Study Evaluating Long-term Efficacy and Safety of Lanifibranor in Adult Patients with Non-cirrhotic Non-alcoholic Steatohepatitis (NASH) and Fibrosis 2 (F2)/Fibrosis 3 (F3) Stage of Liver Fibrosis (NATiV3)

A Phase 3 Study Evaluating Long-term Efficacy and Safety of Lanifibranor in Adult Patients With (NASH) and Fibrosis 2 (F2)/Fibrosis 3 (F3) Stage of Liver Fibrosis

Harmeet Malhi
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-305557-P01-RST
21-008365
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Inclusion Criteria:


1. Male or female, aged ≥18 years at the time of signing informed consent

2. Upon central biopsy reading process: diagnosis of NASH according to the
Steatosis-Activity-Fibrosis (SAF):

1. Steatosis score ≥1

2. Activity score: A3 or A4

3. Fibrosis score: F2 or F3

3. Stable dose for the drugs listed below:

1. Antidiabetic treatment if glucagon-like peptide-1 receptor agonists (GLP1
receptor agonists) or sodium-glucose co-transporter-2 inhibitors (SGLT2
inhibitors): Stable dose for at least 3 months

2. Vitamin E (if at a dose ≥400 IU/day): Stable dose for at least 6 months

3. Statins: Stable dose for at least 3 months

4. All other chronically administered drugs must be stable for at least 3 months prior to
Screening

5. Weight stable for 6 months prior to Screening and between the qualifying liver biopsy
and Baseline (no more than 5% change for both periods)

6. Negative serum pregnancy test at study Screening for females of childbearing potential
confirmed by central laboratory. Females of childbearing potential must practice a
consistent and proper use of highly effective method of contraception throughout the
study and for 1 month after treatment discontinuation.


Exclusion Criteria:


Liver-related:

1. Documented causes of chronic liver disease other than NASH

2. Histologically documented liver cirrhosis (fibrosis stage F4)

3. History or current diagnosis of hepatocellular carcinoma HCC

4. History of or planned liver transplant

5. Positive human immunodeficiency virus (HIV) serology

6. ALT or AST >5 × ULN

7. Abnormal synthetic liver function as defined by Screening central laboratory
evaluation

8. Haemoglobin <110 g/L (11 g/dL) for females and <120 g/L (12 g/dL) for males

9. Patient currently receiving any approved treatment for NASH or obesity

10. Current or recent history (<5 years) of significant alcohol consumption

11. Treatment with drugs that may cause non-alcoholic fatty liver disease (NAFLD)
administered for at least 2 weeks within 12 months prior to qualifying liver biopsy

Glycaemia related:

12. HbA1c >9% at Screening

13. Diabetes mellitus other than type 2

14. Current treatment with insulin

15. Previous or current treatment with PPAR-gamma agonists (thiazolidinediones [TZDs])

Obesity related:

16. Bariatric surgery: Restrictive procedures are allowed, if performed >6 months prior to
the qualifying liver biopsy; malabsorptive procedures and procedures combining both
restrictive and malabsorptive methods are not allowed within 5 years of the qualifying
liver biopsy.

Cardiovascular related:

17. History of heart failure with reduced left ventricular ejection fraction (LVEF)

18. Atrial fibrillation requiring anticoagulation

19. Unstable heart failure

20. Uncontrolled hypertension at Screening (values >160/100 mm Hg)

General safety:

21. Women currently breastfeeding

22. Previous exposure to lanifibranor

23. Participation in any clinical trial investigational medicinal product/device within 3
months from Screening or 5 half-lives from Screening, whichever is longer

24. Concomitant treatment with PPAR-alpha agonists (fibrates)

Eligibility last updated 7/13/22. Questions regarding updates should be directed to the study team contact.

Drug, Other
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Understanding Hiccups from the Perspective of Patients

Understanding Hiccups from the Perspective of Patients

Aminah Jatoi
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305566-H01-RST
21-008466
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Inclusion Criteria:

  • Adult patient, aged 18 or older.
  • English-speaking.
  • Patients who have reported evidence of hiccups in the past five years.
  • Patients who upon contact describe having had hiccups.


Exclusion Criteria:

  • Individuals < 18 years of age.
  • Have not experienced hiccups in the past five years.

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

 

 

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    Quantification of Insulin Synthesis and Secretion In Vivo (The purpose of this study is to quantify Insulin synthesis and secretion in vivo)

    Pilot Study to Quantify Insulin Synthesis and Secretion In Vivo

    Adrian Vella
    All
    18 years to 70 years old
    This study is NOT accepting healthy volunteers
    2021-305570-H01-RST
    21-008441
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    Inclusion Criteria:

    • Previously participated in a prior study and expressed willingness to be recontacted or who respond to intramural and extramural adverts.
    • We propose three groups: 10 individuals who have NFG/NGT, 10 individuals with prediabetes (IGT) and 10 individuals with type 2 diabetes (T2DM).


    Exclusion Criteria:

    • Medications that can affect glucose metabolism (to be determined by PI) or in the case of participants with T2DM taking pioglitazone.
    • For female subjects: positive pregnancy test.
    • Any active systemic illness.
    • Upper gastrointestinal surgery.

    Eligibility last updated 8/20/21. Questions regarding updates should be directed to the study team contact.

     

     

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    A Multicentre, Interventional, Post-marketing, Randomised, Double-blind, Crossover Study to Evaluate the Clinical Safety and Efficacy of AbobotulinumtoxinA (Dysport®) in Comparison With OnabotulinumtoxinA (Botox®) When Treating Adults With Upper Limb Spasticity (DIRECTION)

    A Study to Compare the Safety and Efficacy of Dysport® and Botox® in Adults With Upper Limb Spasticity

    Michael Wainberg
    All
    18 years to 75 years old
    Phase 4
    This study is NOT accepting healthy volunteers
    2021-305576-P01-RST
    21-008454
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    Inclusion Criteria:

    • Participant must be 18 to 75 years of age inclusive, at the time of signing the informed consent.
    • [US/France] Participants with stable Upper Limb Spasticity (ULS) for at least 3 months, in whom treatment of only one upper limb is necessary for the duration of the study.
    • [Canada] Participants with stable post-stroke ULS for at least 3 months, in whom treatment of only one upper limb is necessary for the duration of the study.
    • Participants who are either naïve to Botulinum toxin type A (BoNT-A) for ULS or who have been previously treated with BoNT-A for ULS.
    • Participants with MAS score of at least 2 at elbow, wrist and finger flexors.
    • Participants with DAS score of at least 2 on the Principal Target of Treatment (PTT) (one of four functional domains: dressing, hygiene, limb position and pain).
    • Participants who require BoNT-A injection in all of the following muscles: flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis and biceps brachii.
    • Participants for whom injection of a total dose of 900 Units aboBoNT-A or 360 Units onaBoNT-A is considered by the investigator to be clinically appropriate.
    • Participants who have been stable for at least 3 months prior to study entry in terms of oral antispasticity, anticoagulant and/or anticholinergic medication if treated, and for at least 1 month prior to study entry in terms of occupational and/or physiotherapy treatment, if treated, and are considered by the investigator likely to remain stable for the duration of the study.


    Exclusion Criteria:

    • Major limitations in the passive range of motion in the paretic upper limb.
    • Major neurological impairment (other than limb paresis) that could negatively affect functional performance.
    • Participants clinically requiring injection into any upper limb muscles other than the five muscles of one arm or requiring injection into both arms or any lower limb within the timeframe of the study.
    • Hypersensitivity to any BoNT product or excipients.
    • Hypersensitivity to cow's milk protein (casein).
    • Infection at the proposed injection site(s).
    • Known peripheral motor neuropathic diseases, amyotrophic lateral sclerosis or neuromuscular junction disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome).
    • Any medical condition (including dysphagia or breathing difficulties/compromised respiratory function) that in the opinion of the investigator, might jeopardize the participant's safety.
    • Women who are pregnant or lactating.
    • Participants treated with BoNT of any type for any indication (e.g., bladder injection, headache or cosmetic) within the previous 12 weeks or planned/likely to be treated during the course of the study.
    • Prior history of non-responsiveness to BoNT treatment.
    • Previous surgery, or administration of alcohol or phenol in the study limb 6 months or earlier from study enrolment or planned/likely to be treated during the course of the study.
    • Participants treated with intrathecal baclofen, aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like agents), within the previous 4 weeks or planned/likely to be treated during the course of the study.
    • Participants who received a COVID-19 vaccine injection within 7 days before the first planned study intervention injection, or planned/likely to be injected within 7 days after the first planned study intervention injection.

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

     

     

    Biologic/Vaccine
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    Mayo Clinic — Rochester, MN

    A222001, A Randomized, Double-Blind, Placebo-Controlled Phase II Study of Oxybutynin Versus Placebo for the Treatment of Hot Flashes in Men Receiving Androgen Deprivation Therapy (A222001)

    Testing the Effects of Oxybutynin for the Treatment of Hot Flashes in Men Receiving Hormone Therapy for Prostate Cancer

    Bradley Stish
    Male
    18 years and over
    Phase 2
    This study is NOT accepting healthy volunteers
    2021-305583-P01-RST
    21-008472
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    Inclusion Criteria:

    • Men who are currently receiving androgen deprivation therapy (ADT) for the treatment of prostate cancer. ADT is defined by a history of orchiectomy, or ongoing usage of gonadotropin-releasing hormone agonists or antagonists.
    • Men receiving next generation androgen axis inhibitor therapies including abiraterone, enzalutamide, apalutamide, and darolutamide are eligible.
    • Patients must be on a stable dose of all hormone-directed therapies for at least 28 days prior to registration and must not be planning to discontinue this therapy for at least 42 days following registration.
    • Patients receiving radiation therapy during the study period are eligible.
    • Eligible patient must have bothersome hot flashes for ≥ 14 days prior to registration, defined by an occurrence of ≥ 28 times per week and of sufficient severity to cause the patient to seek therapeutic intervention.
    • Life expectancy of greater than 6 months.
    • Eastern Cooperative Oncology Group (ECOG) performance status
      •0, 1, or 2.
    • In order to complete the mandatory patient-completed measures, participants must be able to speak and/or read English.


    Exclusion Criteria:

    • No current use or future planned use of any of the following agents during the study period: drugs that are not Food and Drug Administration (FDA) approved for use in humans, androgens, estrogens, progesterone analogs, gabapentin, selective serotonin reuptake inhibitor (SSRI)/serotonin and norepinephrine reuptake inhibitor (SNRI) anti-depressants, cholinergic agonists, cholinesterase inhibitors, or complementary/alternative medicine taken for the purpose of managing hot flashes. Prior use of these agents is permitted as long as they are discontinued before registration.
    • No current or prior use of oxybutynin.
    • Patients with a history of any of the following contraindications to oxybutynin are not eligible:
      • gastroparesis or gastrointestinal obstructive disorders;
      • significant gastric reflux symptoms not controlled by medication; ulcerative colitis;
      • narrow-angle glaucoma;
      • urinary retention requiring indwelling or intermittent self-catheterization within the prior 6 months;
      • hypersensitivity to oxybutynin or any other components of the product; current uncontrolled hyperthyroidism;
      • uncontrolled coronary artery disease or a history of myocardial infarction within the prior 12 months;
      • New York Heart Association (NYHA) class II-IV congestive heart failure;
      • symptomatic cardiac arrhythmias;
      • current uncontrolled hypertension;
      • myasthenia gravis; or
      • dementia.

    Eligibility last updated 11/22/21. Questions regarding updates should be directed to the study team contact.

    Drug, Other
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    A PHASE IV RANDOMIZED, SINGLE-BLIND TRIAL OF LIPOSOMAL BUPIVACAINE (EXPAREL®) FOR PAIN CONTROL IN COSTAL CARTILAGE HARVEST (LBPC)

    Pain Control for Undergoing Costal Cartilage Harvesting

    Michael Olson
    All
    18 years and over
    Phase 4
    This study is NOT accepting healthy volunteers
    2021-305596-H01-RST
    21-008473
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    Inclusion Criteria:

    • Diagnosis of functional nasal obstruction or aesthetic nasal concern requiring nasal surgery with costal cartilage harvest.
    • Male or female with age ≥ 18 years.
    • Willing and able to understand and provide written informed consent.


    Exclusion Criteria:

    • Age < 18 years of age.
    • Known pregnancy.
    • Women who are currently nursing a child.
    • History of coagulopathy; such as hemophilia or Von Willebrand disease, or any congenital or acquired bleeding disorder.
    • Use of anticoagulation medication during the study; i.e. aspirin, Coumadin, Plavix, or medications similar in class to these medications will exclude the patient from participation.
    • Inability to provide informed consent (patients under guardianship).
    • Known hypersensitivity to local anesthetics
    • History of cardiac disease; such as current impaired cardiovascular function, past history of myocardial infarction, congenital heart disease, current cardiac symptoms; i.e. angina, shortness of breath, or chest pain as determined by history or review of the medical record.
    • History of complex pulmonary disease; such as uncontrolled asthma, COPD, or interstitial lung disease as determined by history or review of the medical record. 
    • Impaired renal function as documented in the medical record in the last 3 months with a serum creatinine greater than 1.2 mg/dL or glomerular filtration rate < 60 mL/min/BSA as determined by history or review of the medical record.
    • History of or current hepatic disease as documented by liver function test abnormality in the last 3 months as determined by history or review of the medical record. 

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

     

    Drug, Costochondrectomy, Harvest of cartilage, Pain control, Reconstruction of nose
    Nasal obstruction, Postoperative pain
    Bupivacaine, Costochondral rib graft, Epinephrine, Lidocaine, Nasal obstruction, Nasal repair, Nervous system, Postoperative pain, Respiratory system, Rhinoplasty, bupivacaine liposome, epinephrine, epinephrine / lidocaine, lidocaine
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    Diabetes Endothelial Keratoplasty Study (DEKS): Impact of Diabetes on Corneal Transplant Success and Endothelial Cell Loss (DEKS)

    Impact of Donor Diabetes on DMEK Success and Endothelial Cell Loss (DEKS)

    Sanjay Patel
    All
    30 years to 90 years old
    Not Applicable
    This study is NOT accepting healthy volunteers
    2021-305614-P01-RST
    21-008560
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    Inclusion Criteria
    •Participant:

    • Age range 30- < 91 years with minimum life expectancy of at least 1 year.
    • Willingness to return to study site for follow up at 1 month and 1 year.
    • Fluent in English or Spanish.
    • Willingness to have fingerstick blood sample collected to determine HbA1c level at entry and at 1 year. If determined to be diabetic at baseline, participant will be advised to seek medical care.

    Inclusion Criteria
    •Study Eye:

    • Clinically recommended for DMEK, and able to schedule DMEK between 5 to 90 days after enrollment.
    • Presence of a condition related to endothelial dysfunction which will be treated by DMEK.  Eligible indications for DMEK include:
      • Presence of Fuchs endothelial corneal dystrophy (FECD) meeting at least one of the following:
      • Phakic FECD with or without cataract;
      • Triple procedure including DMEK for FECD, cataract extraction and posterior chamber intraocular lens implantation (IOL) is allowed;
      • Pseudophakic FECD with posterior capsule supported, sulcus supported, or scleral-fixated posterior chamber IOL b. Pseudophakic corneal edema with posterior capsule supported, sulcus supported, or scleral-fixated posterior chamber IOL without FECD;
      • Failed Descemet stripping automated endothelial keratoplasty (DSAEK) or DMEK without exclusionary criteria, as described below.


    Exclusion Criteria:

    • Pregnant or planning to become pregnant prior to the DMEK study surgery, based on verbal report.
    • Lack cognitive capacity such that consent could not be provided.
    • Presence of a condition that has a high probability for failure (e.g., failed penetrating keratoplasty, uncontrolled uveitis).
    • Stromal vascularization that will impede assessment of recipient stroma clarity.
    • Other primary endothelial dysfunction conditions including posterior polymorphous corneal dystrophy and congenital hereditary corneal dystrophy.
    • Indication for surgery that is not suitable for DMEK (e.g, keratoconus, stromal dystrophies and scars).
    • Aphakic corneal edema with or without FECD.
    • Anterior chamber IOL in study eye prior to DMEK or planned placement of anterior chamber IOL during DMEK.
    • Planned IOL exchange of an anterior chamber IOL with a posterior chamber IOL in study eye at time of study DMEK.
    • Pre-operative central sub-epithelial or stromal scarring that could impact post-operative recipient stromal clarity assessment.
    • Presence of anterior synechiae.
    • Peripheral anterior synechiae in the angle greater than a total of three clock hours.
    • Uncontrolled glaucoma with or without prior filtering surgery, tube shunt placement, or MIGS. Uncontrolled glaucoma is defined as intraocular pressure > 25mm Hg.
    • Controlled glaucoma with prior tube shunt placement for glaucoma (controlled glaucoma with MIGS is allowed).
    • Fellow eye visual acuity < 20/200 due to an ocular condition other than a cornea disease that would be a candidate for DMEK.
    • IOP < 8 mmHg.
    • Topical Rho kinase inhibitor, including Rhopressa, used within 1 month prior to study entry and anticipated during the course of the study.

    Eligibility last updated 5/18/22. Questions regarding updates should be directed to the study team contact.

    Procedure/Surgery
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    Assessment of CXCL10 in Plasma-derived Small Extracellular Vesicles in Children with New Onset Diabetes (CXCL10)

    Assessment of CXCL10 in Plasma-derived Small Extracellular Vesicles in Children with New Onset Diabetes

    Ana Creo
    All
    1 years to 18 years old
    This study is NOT accepting healthy volunteers
    2021-305620-H01-RST
    21-008585
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    Inclusion Criteria:

    • Clinical diagnosis of diabetes based upon an elevated hemoglobin A1C.


    Exclusion Criteria:

    • Diagnosis of Diabetic Nephropathy.
    • Active or unresolved Diabetic Ketoacidosis (DKA).
    • Steroid Induced Hyperglycemia.

    Eligibility last updated 8/18/21. Questions regarding updates should be directed to the study team contact.

     

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    Pulmonary Hypertension and Chronic Kidney Disease (PH and CKD)

    Pulmonary Hypertension and Chronic Kidney Disease

    Hilary DuBrock
    All
    18 years and over
    This study is NOT accepting healthy volunteers
    2021-305626-H01-RST
    21-008593
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    Inclusion Criteria:

    • Subjects with chronic kidney disease (estimated glomerular filtration rate < 60).
    • Recruitment will primarily focus on patients with end stage renal disease who are being considered for renal transplantation or initiation of hemodialysis.
    • Minorities will be included.


    Exclusion Criteria:

    • Individuals < 18 years of age.
    • Subjects not diagnosed with chronic kidney disease.

    Eligibility last updated 8/18/21. Questions regarding updates should be directed to the study team contact.

     

     

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    Integrated Genomics and Patient-derived Cancer Models (Integrated Genomics)

    A Study Investigating Integrated Genomics and Patient-derived Cancer Models

    Aaron Mansfield
    All
    18 years and over
    This study is NOT accepting healthy volunteers
    2021-305632-H01-RST
    21-008623
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    Inclusion Criteria:

    • Patients must understand and provide written informed consent prior to initiation of any study-specific procedures.
    • ≥ 18 years of age.
    • Patients must have a diagnosis of confirmed malignancy.
    • Patient is a good medical candidate for a standard of care or research biopsy or surgical procedure to obtain tissue or has tissue available for analysis that has been collected within 12 months of signing consent.

     


    Exclusion Criteria:

    • Uncontrolled concurrent illness including psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent.
    • Inaccessible tumor for biopsy or patient does not have tumor tissue available for research use.
    • Biopsy must not be considered to be more than minimal risk to the patient.
    • Contraindications to percutaneous biopsy:
      • Significant coagulopathy that cannot be adequately corrected;
      • Severely compromised cardiopulmonary function or hemodynamic instability;
      • Lack of a safe pathway to the lesion;
      • Inability of the patient to cooperate with, or to be positioned for, the procedure.

    Eligibility last updated 11/10/21. Questions regarding updates should be directed to the study team contact.

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    Prospective Biobanking Study in Immunodeficiency Patients

    Biobanking Study in Immunodeficiency Patients

    Avni Joshi
    All
    Not specified
    This study is NOT accepting healthy volunteers
    2021-305635-H01-RST
    21-008664
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    Inclusion Criteria:

    • Capable and willing to provide informed consent.
    • Confirmed or suspected physician diagnosis of Primary Immunodeficiency.


    Exclusion Criteria:

    • Not willing to provide consent.
    • Not diagnosed with Primary Immunodeficiency.

    Eligibility last updated 9/10/21. Questions regarding updates should be directed to the study team contact.

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    Phase 1-2a Safety, Tolerability, and Pharmacodynamics Controlled Study of NOV-001 in Healthy Volunteers and Patients with Enteric Hyperoxaluria (NOV-001-CL01)

    Safety, Tolerability, and Pharmacodynamics of NOV-001 in Adult Subjects

    John Lieske
    All
    18 years to 65 years old
    Phase 1/2
    This study is NOT accepting healthy volunteers
    2021-305641-P01-RST
    21-008943
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    Stage 1 Key

    Inclusion Criteria:


    - Ages 18 to 55

    - Body mass index (BMI) < 38 kg/m2.

    - Healthy as defined by no clinically relevant abnormalities being identified by a
    detailed medical history, physical examination, and clinical laboratory tests.

    - If woman of child-bearing potential, must not be pregnant, and must also agree to use
    an appropriate highly-effective contraceptive.

    - Willing and able to comply with all study requirements, including duration of stay at
    inpatient unit, dietary restrictions, daily study product administration, pregnancy
    testing and contraception (if applicable), stool collections, and blood and urine
    collections.

    Stage 1 Key
    Exclusion Criteria:


    - Estimated glomerular filtration rate (eGFR) < 80 mL/min/1.73 m2 at Screening.

    - Oral or parenteral antibiotics within 4 weeks prior to Screening, or anticipation of
    the need for such antibiotics during the Screening or treatment periods of the study.

    - Current or history of any clinically significant medical illness or disorder the
    Investigator considers should exclude the subject from the study.

    - Participation in any investigational intervention study within 30 days prior to study
    product administration in this study.

    - Known hypersensitivity to omeprazole.

    - Applicable only to certain study groups depending on emerging Stage 1 data: no current
    or anticipated use during the screening or treatment periods of the study of
    medications that have the potential for drug-drug interactions (DDI) with omeprazole.

    Stage 2 Key
    Inclusion Criteria:


    - Ages 18 to 65.

    - Hyperoxaluria secondary to Roux-en-Y gastric bypass surgery or to biliopancreatic
    diversion with duodenal switch (BPD-DS) surgery.

    - 24-Hour urinary oxalate (UOx) ≥ 60 mg.

    - If woman of child-bearing potential, must not be pregnant and must also agree to use
    an appropriate highly effective contraceptive method.

    - Must, in the opinion of the Investigator, be in otherwise good health.

    - Willing and able to comply with all study requirements, including dietary
    restrictions, daily study product administration, pregnancy testing and contraception
    (if applicable), stool collections, and blood and 24-hour urine collections.

    Stage 2 Key
    Exclusion Criteria:


    - Chronic kidney disease with eGFR < 30 mL/min/1.73 m2 at Screening.

    - Evidence of current acute renal injury or ongoing clinically significant renal
    disease.

    - Oral or parenteral antibiotics within 4 weeks prior to Screening, or anticipation of
    the need for such antibiotics during the Screening or treatment periods of the study
    (topical antibiotics are permissible.)

    - Taking during the study any treatment for hyperoxaluria except for NOV-001, other than
    stable treatments for the management of kidney stones.

    - Taking Vitamin C ≥ 300 mg/day for > 10 days within 7 days prior to Screening;
    unwilling or unable to discontinue and/or avoid Vitamin C supplementation for the
    duration of study product treatment.

    - Known active autoimmune disorder or other condition requiring high dose of systemic
    corticosteroids (i.e., > 10 mg/day prednisone or equivalent) or other
    immunosuppressant therapy.

    - Current or history of any clinically significant medical illness or disorder other
    than enteric hyperoxaluria that the Investigator considers should exclude the patient
    from the study.

    - Participation in any investigational intervention study within 30 days prior to study
    product administration in this study.

    - Known hypersensitivity to omeprazole.

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

    Eligibility last updated 9/15/22. Questions regarding updates should be directed to the study team contact.

    Biologic/Vaccine, Drug, Other
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    (ECTx) ELU-FRa-1 / Dose Escalation and Expansion Clinical Study to Evaluate the Safety and Efficacy of ELU001 in Subjects Who Have Advanced, Recurrent or Refractory FRα Overexpressing Tumors (ELU-Fra-1)

    A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRα)

    Wen Wee Ma
    All
    18 years and over
    Phase 1/2
    This study is NOT accepting healthy volunteers
    2021-305646-P01-RST
    21-008883
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    ​​​​​

    Inclusion Criteria:

    • Male or female subjects aged 18 or older at the time of signed informed consent.
    • In the opinion of the Investigator, there is no other meaningful life-prolonging therapy option available.
    • Population:
      • Part 1: Must have documented diagnosis of ovarian cancer, endometrial cancer, colorectal cancer, gastric cancer, gastroesophageal junction cancer, triple negative breast cancer, non-small cell lung cancer, or cholangiocarcinoma.
      • Part 2 Stage 1: Must have one of the following cancer types indicated below with the corresponding expression level of FRα.:
      • Ovarian Cancer
        • Moderate and/or High
      • Endometrial Cancer
        • Moderate and/or High
      • Colorectal Cancer
        • Moderate and/or High
      • Gastric Cancer
        • Moderate and/or High
      • Gastroesophageal Junction Cancer
        • Moderate and/or High
      • Triple Negative Breast Cancer
        • Moderate and/or High
      • Non-small cell lung cancer
        • Moderate and/or High
      • Cholangiocarcinoma
        • Moderate and/or High
      • Specific cancer types from the table above will be selected by the Sponsor, in consultation with the Part 1 CSRC and other experts, at the conclusion of Part 1 Dose Escalation. In addition, moderate and high FRα expression thresholds will be defined and communicated by the Sponsor to Investigators upon completion of translational testing prior to the start of Part 2.

    Part 2 Stage 2 or Registration Study:

    • Must have documented FRα expression in one of the topoisomerase 1 inhibitor-sensitive tumor types evaluated in Part 2 Stage 1. Specific tumor groups will be selected by the Sponsor, in consultation with the CSRC and/or Steering Committee (SC) and other experts, at the conclusion of Part 2 Stage 1.
    • Folate receptor α (FRα) expression:
      • Part 1: Must provide archival tumor tissue or a newly obtained tumor biopsy specimen prior to the first dose of study drug for retrospective FRα expression analysis. The availability of the FRα expression result is not required to start study drug administration.
      • Part 2: Must provide archival tissue or a newly obtained tumor biopsy specimen prior to the first dose of study drug for prospective determination of FRα overexpression at the Sponsor-designated laboratory. The FRα expression result is required prior to the initiation of study drug administration.
    • In Part 1, measurable disease or, in the absence of measurable disease, non-measurable disease (lesions considered truly non-measurable include leptomeningeal disease, ascites, pleural or pericardial effusion, inflammatory breast disease, lymphangitic involvement of skin or lung, abdominal masses/abdominal organomegaly identified by physical exam that is not measurable by reproducible imaging techniques), as per RECIST v1.1. In Part 2, measurable disease (only), as per RECIST v1.1.
      • Note:  A lytic or mixed lytic-blastic bone lesion with a soft tissue component assessed on CT/MRI can be measurable if the minimum size criteria are met.
    • For other criteria, refer to RECIST v1.1.
    • Expected survival of at least 3 months.
    • In Part 1, Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 or 2.
    • In Part 2, ECOG Performance Status of 0 or 1.
    • Adequate organ function defined as:
      • Absolute neutrophil count ≥ 1,500/μL;
      • Platelets ≥ 100,000/μL;
      • Hemoglobin ≥ 8 g/dL;
      • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (including subjects with documented Gilberts syndrome, liver metastases, or other etiologies);
      • Aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 5 x ULN;
      • Calculated creatinine clearance ≥ 60 mL/min using the Cockcroft-Gault equation.
    • Recovered from any previous surgery and no history of major surgery within the last 28 days prior to start of study drug.
    • For women of childbearing potential, willingness to avoid pregnancy by using an effective method of contraception from the first dose of ELU001 up to 5 times the half-life of ELU001 treatment (about 10 days) plus 6 months after the last dose of study drug (or longer, if required by Regulatory Authority or local practice).
    • For males who are capable of fathering a child, willingness to take precautions that are effective in preventing pregnancy from the first dose of ELU001 and up to 5 times the half-life of ELU001 treatment (about 10 days) plus 3 months after the last dose of study drug (or longer, if required by Regulatory Authority or local practice).
    • Willing and able to understand and comply with all aspects of the protocol.
    • Provided informed consent prior to any protocol-related procedures, including screening evaluations.


    Exclusion Criteria:

    • Clinically significant active or chronic corneal disorder.
    • Received investigational anti-cancer treatment, other anti-neoplastic therapy, including cytotoxics, targeted agents, biological therapy including antibodies and endocrine therapies ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, prior to starting study drug, whichever is shorter.
    • Require use of folate-containing supplements during the treatment period.
    • Known medical history of:
      • Clinically significant cardiovascular and respiratory conditions including myocardial infarction within 1 year, uncontrolled or unstable angina, congestive heart failure (New York Heart Association [NYHA] Class III or IV), or arrhythmia (Grade 2 or higher), within 5 years;
      • Another malignancy within 3 years before the first dose, or previously diagnosed with another malignancy, and have any evidence of residual disease. Subjects with non-melanoma skin cancer or cervix carcinoma in situ, treated and radiated early prostate cancer if they have undergone complete resection, or chronic lymphocytic leukemia (CLL) who is on close monitoring and treatment is not required, are not excluded;
      • Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks and was related to the most recent treatment;
      • Serious, uncontrolled medical disorder such as seizures, nonmalignant systemic disease, or active, uncontrolled infection or active infection causing fever. Examples include, but are not limited to, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent. Subjects with chronic diseases that are well controlled (e.g., diabetes mellitus, hypertension (< 150 systolic blood pressure [sBP] and < 90 diastolic blood pressure [BP]) are eligible;
      • Part 1 only: Recognized immunodeficiency condition including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary, or congenital immunodeficiency’s (human immunodeficiency virus (HIV) infection, see below).
    • Any of the following conditions (testing is not required in this protocol, unless required by Regulatory Authority or local practice)
      • Known HIV-infected subjects, unless on effective anti-retroviral therapy with an undetectable viral load within 6 months; or
      • Known or suspected hepatitis B if active infection (subjects with chronic hepatitis B infection must have an undetectable Hepatitis B Virus (HBV) viral load on suppressive therapy, if indicated; positive surface antibody alone is not an exclusion); or
      • Known or suspected hepatitis C infection which has not been treated and cured unless currently on treatment with an undetectable viral load.
    • Active medical conditions of:
      • Subjects in Part 1 with autoimmune disease (e.g., rheumatoid arthritis, Systemic Lupus Erythematosus (SLE), ulcerative colitis, Crohn's Disease, Multiple Sclerosis (MS), ankylosing spondylitis, thyroiditis) requiring continuing immune suppressive therapy;
      • Subjects in Part 1 with brain or leptomeningeal metastases; in Part 2, subjects with symptomatic brain or leptomeningeal metastases with any lesion greater than 3 cm, or evidence of herniation or hemorrhage.
    • Any of the following recent treatments or therapies:
      • Subject has received a transfusion (platelets or red blood cells) ≤ 2 weeks prior to first dose of study drug;
      • Chronic therapeutic corticosteroid use, defined as > 5 days of prednisone or equivalent in Part 1, except for inhalers or those on a pre-planned steroid taper.
      • Note: Premedication with corticosteroids to prevent or decrease the severity of infusion related reactions per institutional standard of care is allowed;
      • Chronically treated with systemic doses of other immunosuppressive drugs such as cyclosporine, methotrexate, adrenocorticotropic hormone (ACTH) or immune suppressive monoclonal antibodies.
    • Female subjects who are lactating or breast feeding or have a positive pregnancy test within 7 days prior to first dose of study drug.
    • Any condition(s) that, in the opinion of the Investigator, would increase the risk for toxicities from study drug, interfere with subject compliance or conduct of this study.
    • In the opinion of the Investigator, there is significant risk to a subject when the tumor tissue biopsy specimen procedure is performed
    • Subjects who have a QTcF > 470 ms within 4 weeks prior to the first dose of study drug.

    Eligibility last updated 10/26/22. Questions regarding updates should be directed to the study team contact.

     

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    An Open-Label Extension and Safety Monitoring Study of Acoramidis (AG10) in Participants With Symptomatic Transthyretin Amyloid Cardiomyopathy Who Completed the Phase 3 ATTRibute-CM Trial (AG10-301)

    Open-Label Safety Study of Acoramidis (AG10) in Symptomatic ATTR Participants

    Martha Grogan
    All
    18 years to 90 years old
    Phase 3
    This study is NOT accepting healthy volunteers
    2021-305651-P01-RST
    21-008725
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    Inclusion Criteria:


    1. Completed 30 months of the blinded study treatment in Study AG10-301 and the Study
    AG10-301 Month 30 visit including assessments and procedures.

    2. Have the ability to understand and sign a written informed consent form, which must be
    obtained prior to initiation of study procedures.

    3. Female participants of childbearing potential who engage in heterosexual intercourse
    must agree to use a highly effective method of contraception beginning with enrollment
    and continuing for 30 days after the last dose of acoramidis. Female participants
    using oral contraceptives must agree to use an additional birth control method. While
    not considered highly effective, a double-barrier method is acceptable. A male
    participant who is sexually active with a female of childbearing potential and has not
    had a vasectomy must agree to use a double-barrier method of birth control.


    Exclusion Criteria:


    1. Acute myocardial infarction, acute coronary syndrome or coronary revascularization
    within 90 days prior to Day 1 stroke or transient ischemic attack (TIA) within 90 days
    prior to Day 1.

    2. Has hemodynamic instability, that in the judgment of the Investigator, would pose too
    great a risk for participation in the study.

    3. Has had a heart and/or liver transplant or is on the heart transplantation list within
    the year prior to Day 1

    4. Has had implantation of a cardiac mechanical assist device (CMAD) or is scheduled for
    implantation of a CMAD

    5. Has confirmed diagnosis of light-chain (AL) amyloidosis at any time during Study
    AG10-301.

    6. Has estimated glomerular filtration rate (eGFR) by modification of diet for renal
    disease (MDRD) formula < 15 mL/min/1.73 m2 at Month 27 of Study AG10-301 or at any
    subsequent central lab value prior to Day 1.

    7. Known hypersensitivity to acoramidis, its metabolites, or formulation excipients.

    8. At the end of Study AG10-301 or at Day 1 of Study AG10-304 (or any time during the
    study), participant is on prohibited medication.

    9. Females who are pregnant or breastfeeding. A negative urine pregnancy test at the Day
    1 visit and at each study visit are required for female participants of childbearing
    potential.

    10. In the judgment of the Investigator or Medical Monitor, has any clinically important
    ongoing medical condition or laboratory abnormality or condition that might jeopardize
    the participant's safety, increase their risk from participation, or interfere with
    the study.

    11. Participation in another interventional clinical trial (with the exception of Study
    AG10-301) within 30 days prior to dosing. Participation in observational and/or
    registry studies should be discussed with the Medical Monitor.

    12. Has any condition that in the opinion of the Investigator or Medical Monitor would
    preclude compliance with the study protocol such as a history of substance abuse,
    alcoholism, or a psychiatric condition.

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

    Eligibility last updated 8/24/22. Questions regarding updates should be directed to the study team contact.

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    The Role Of Interferon-gamma In Immune Responses To Invasive Candidiasis (Candiada)

    The Role Of Interferon-gamma In Invasive Candidiasis

    Paschalis Vergidis
    All
    18 years and over
    Not Applicable
    This study is NOT accepting healthy volunteers
    2021-305653-H01-RST
    21-008735
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    Inclusion Criteria

    • Willing and able to provide written informed consent. If the subject is unable to consent for himself/herself, a legally authorized representative must provide informed consent on his/her behalf.
    • Males or females ≥ 18 years of age.
    • Evidence of candidemia or invasive candidiasis based on growth of Candida species from any of the following: blood, peritoneal fluid, intra-abdominal collection/abscess, pancreatic fluid/tissue, peripancreatic fluid, pleural fluid/tissue.


    Exclusion Criteria:

    • Severe neutropenia (absolute neutrophil count < 500 cells/microL).
    • Profound lymphopenia (< 300 cells/microL).
    • The Principal Investigator (PI) is of the opinion that the subject should not participate in the study.

    Eligibility last updated 8/23/21. Questions regarding updates should be directed to the study team contact.

     

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    Genomic and Environmental Basis of Imperforate Anus (IA)

    Genomic and Environmental Basis of Imperforate Anus

    Lisa Schimmenti
    All
    Not specified
    This study is NOT accepting healthy volunteers
    2021-305657-H01-RST
    21-008736
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    Inclusion Criteria:

    • Diagnosis of imperforate anus.


    Exclusion Criteria:
     

    • Lack of a parent or guardian to provide informed consent.

    Eligibility last updated 9/24/21. Questions regarding updates should be directed to the study team contact.

     

    Anal atresia, Genetic testing, Skin biopsy
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    A Phase 1b, Open Label, Global, Multicenter, Dose Determination, Randomized Dose Expansion Study to Determine the Maximum Tolerated Dose, Assess the Safety and Tolerability, Pharmacokinetics and Preliminary Efficacy of Iberdomide (CC-220) in Combination With R-CHOP-21 and CC-99282 in Combination With R-CHOP-21 for Subjects With Previously Untreated, Aggressive B-cell Lymphoma (CC-220-DLBCL-001)

    Study of Safety and Efficacy of Iberdomide (CC-220) and CC-99282 Combined With R-CHOP to Treat Lymphoma

    Grzegorz Nowakowski
    All
    18 years and over
    Phase 1
    This study is NOT accepting healthy volunteers
    2021-305666-P01-RST
    21-008752
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    Inclusion Criteria:


    - Participants must satisfy the following criteria to be enrolled in the study:

    1. Is ≥ 18 years of age at the time of signing the informed consent form (ICF).

    2. Participant has histologically confirmed (per local evaluation) diagnosis of de
    novo, previously untreated, a-BCL according to 2016 WHO classification.

    3. Participant has International Prognostic Index (IPI) score 0-5 in Part 1 and IPI
    2-5 in Part 2.

    4. Participants must have measurable disease defined by at least one FDG-avid lesion
    for FDGavid subtype and one bi-dimensionally measurable (> 1.5 cm in longest
    diameter) disease by computed tomography (CT) or magnetic resonance imaging
    (MRI), as defined by the Lugano classification (Cheson, 2014).

    5. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status
    of 0, 1, or 2.

    6. Participants must have the following laboratory values:

    1. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L or ≥ 1.0 x 109/L in case of
    documented bone marrow involvement (> 50% or tumor cells), without growth
    factor support for 7 days (14 days if peg-G-CSF)

    2. Hemoglobin (Hb) ≥ 8 g/dL

    3. Platelets (PLT) ≥ 75 x 109/L or ≥ 50 x 109/L in case of documented bone
    marrow involvement (>50% or tumor cells), without transfusion for 7 days

    4. Aspartate aminotransferase / serum glutamic oxaloacetic transaminase
    (AST/SGOT) and alanine aminotransferase / serum glutamate pyruvic
    transaminase (ALT/SGPT) ≤ 2.5 x upper limit of normal (ULN). In the case of
    documented liver involvement by lymphoma, ALT/SGPT and AST/SGOT must be ≤
    5.0 x ULN.

    5. Serum total bilirubin ≤ 2.0 mg/dL except in cases of Gilbert syndrome, then
    ≤ 5.0 mg/dl

    6. Estimated serum creatinine clearance of ≥ 50 mL/min

    7. All participants must:

    1. Have an understanding that the study drug could have a potential teratogenic
    risk.

    2. Agree to follow all requirements defined in the Pregnancy Prevention Program
    for CC-220 or CC-99282 Pregnancy Prevention Plan for Participants in
    Clinical trials.

    8. Females of childbearing potential (FCBP) must:

    a. Have two negative pregnancy tests as verified by the investigator prior to
    starting study therapy.

    9. Male participants must:

    1. Practice true abstinence or agree to use a condom during sexual contact with
    a pregnant female or a female of childbearing potential while participating
    in the study.


    Exclusion Criteria:


    - The presence of any of the following will exclude a participant from enrollment:

    1. Any significant medical condition, active infection (including SARS-CoV-2
    suspected or confirmed), laboratory abnormality, or psychiatric illness that
    would prevent the participant from participating in the study.

    2. Any condition including the presence of laboratory abnormalities, which places
    the participant at unacceptable risk if he/she were to participate in the study.

    3. Any other subtype of lymphoma.

    4. Documented or suspected CNS involvement by lymphoma.

    5. Persistent diarrhea or malabsorption ≥ Grade 2 (NCI CTCAE v5.0), despite medical
    management.

    6. Peripheral neuropathy ≥ Grade 2 (NCI CTCAE v5.0).

    7. Chronic systemic immunosuppressive therapy or corticosteroids

    8. Impaired cardiac function or clinically significant cardiac disease, including
    any of the following:

    a. Left ventricular ejection fraction (LVEF) < 45% as determined by multigated
    acquisition scan (MUGA) or echocardiogram (ECHO)

    9. Major surgery ≤ 2 weeks prior to starting CC-220 or CC-99282; participant must
    have recovered from any clinically significant effects of recent surgery.

    10. Any condition causing inability to swallow tablets.

    11. Known seropositivity for or active viral infection with human immunodeficiency
    virus (HIV)

    12. Known chronic active hepatitis B (hepatitis B surface antigen [HBsAg] positive
    and/or hepatitis B core antibody [anti-HBc] positive with viral DNA positive) or
    C (positive serology requiring treatment and/or with evidence of liver damage)
    infection

    13. History of other malignancy, unless being free of the disease for ≥ 3 years;
    exceptions to the ≥ 3-year time limit include history of the following:

    1. Localized nonmelanoma skin cancer

    2. Carcinoma in situ of the cervix

    3. Carcinoma in situ of the breast

    4. Incidental histologic finding of prostate cancer (T1a or T1b as per Tumor
    Node Metastasis [TNM] staging system) or prostate cancer that has been
    treated with curative intent.

    14. Hypersensitivity to the active substance or to murine proteins, or to any of the
    other excipients of rituximab.

    15. Known hypersensitivity to any component of CHOP regimen.

    16. Known allergy to thalidomide, pomalidomide, or lenalidomide.

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

    Eligibility last updated 7/28/22. Questions regarding updates should be directed to the study team contact.

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    A Phase 3b/4, Double-masked, Randomized, International, Parallel-assignment, Multicenter Trial in Patients with Thyroid Eye Disease to Evaluate the Safety and Tolerability of Different Dosing Durations of Teprotumumab (HZNP-TEP-402)

    TEPEZZA® (Teprotumumab-trbw) Post-Marketing Requirement Study

    Marius Stan
    All
    18 years to 80 years old
    Phase 4
    This study is NOT accepting healthy volunteers
    2021-305679-P01-RST
    21-008801
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    Inclusion Criteria:


    1. Written informed consent.

    2. Male or female between the ages of 18 and 80 years, inclusive, at Screening.

    3. Initial diagnosis of TED within 7 years prior to Screening.

    4. Proptosis ≥3 mm from baseline (prior to diagnosis of TED), as estimated by treating
    physician, and/or proptosis >3 mm above normal for race and gender.

    5. Participants must be euthyroid with the baseline disease under control or have mild
    hypo or hyperthyroidism (defined as free thyroxine and free triiodothyronine levels
    <50% above or below the normal limits) at Screening. Every effort should be made to
    correct the mild hypo- or hyperthyroidism promptly and to maintain the euthyroid state
    for the duration of the trial.

    6. Does not require immediate surgical ophthalmological intervention and is not planning
    corrective surgery/irradiation during the course of the trial.

    7. Diabetic participants must have HbA1c ≤8.0% at Screening.

    8. Participants with a history of IBD (ulcerative colitis or Crohn's disease) must be in
    clinical remission for at least 3 months, with no history of bowel surgery within 6
    months prior to Screening and no planned surgery during the trial. Concomitant stable
    therapies for IBD without modifications in the 3 months prior to Screening are
    allowed.

    9. Women of childbearing potential (including those with an onset of menopause <2 years
    prior to Screening, non-therapy-induced amenorrhea for <12 months prior to Screening
    or not surgically sterile [absence of ovaries and/or uterus]) must have a negative
    serum pregnancy test at Screening and negative urine pregnancy tests at all
    protocol-specified time points (i.e., prior to each dose and throughout the
    participant's participation in the Follow-up Period); participants who are sexually
    active with a non-vasectomized male partner must agree to use 2 reliable forms of
    contraception during the trial, 1 of which is recommended to be hormonal, such as an
    oral contraceptive. Hormonal contraception must be started at least 1 full cycle prior
    to Baseline and continue for 180 days after the last dose of teprotumumab. Highly
    effective contraceptive methods (with a failure rate <1% per year), when used
    consistently and correctly, include implants, injectables, combination oral
    contraceptives, some intrauterine devices, tubal ligation, sexual abstinence or
    vasectomized partner.

    10. Willing and able to comply with the prescribed treatment protocol and evaluations for
    the duration of the trial.


    Exclusion Criteria:


    1. Decreased best-corrected visual acuity due to optic neuropathy, as defined by a
    decrease in vision of 2 lines on the Snellen chart, new visual field defect or color
    defect secondary to optic nerve involvement within the last 6 months.

    2. Corneal decompensation unresponsive to medical management.

    3. Decrease in proptosis of ≥2 mm in the study eye between Screening and Baseline.

    4. Prior orbital irradiation, orbital decompression or strabismus surgery.

    5. Planned eyelid surgery during the course of the trial.

    6. Alanine aminotransferase or aspartate aminotransferase >3 × the upper limit of normal
    or estimated glomerular filtration rate ≤30 mL/min/1.73m2 at Screening.

    7. Use of any steroid (intravenous [IV], oral, steroid eye drops) for the treatment of
    TED or other conditions within 3 weeks prior to Screening. Steroids cannot be
    initiated during the trial. Exceptions include topical and inhaled steroids, as well
    as steroids used to treat infusion reactions.

    8. Any treatment with rituximab (Rituxan® or MabThera®) within 12 months prior to the
    first infusion of teprotumumab or tocilizumab (Actemra® or Roactemra®) within 6 months
    prior to the first infusion of teprotumumab. Use of any other non-steroid
    immunosuppressive agent within 3 months prior to the first infusion of teprotumumab.

    9. Any previous treatment with teprotumumab, including previous enrollment in this trial
    or participation in a prior teprotumumab trial.

    10. Treatment with any mAb within 3 months prior to Screening.

    11. Identified pre-existing ophthalmic disease that, in the judgment of the Investigator,
    would preclude trial participation or complicate interpretation of trial results.

    12. Use of an investigational agent for any condition within 60 days or 5 half-lives,
    whichever is longer, prior to Screening or anticipated use during the course of the
    trial.

    13. Malignant condition in the past 5 years (except successfully treated basal/squamous
    cell carcinoma of the skin or cervical cancer in situ).

    14. Pregnant or lactating women.

    15. Current drug or alcohol abuse or history of either within the previous 2 years, in the
    opinion of the Investigator or as reported by the participant.

    16. Known hypersensitivity to any of the components of teprotumumab or prior
    hypersensitivity reactions to mAbs.

    17. Human immunodeficiency virus, untreated or positive viral load for hepatitis C or
    hepatitis B infections.

    18. Any other condition that, in the opinion of the Investigator, would preclude inclusion
    in the trial.

    19. After 150 participants with a CAS <3 at Baseline have been randomized, an additional
    exclusion criterion will apply: CAS <3 at Baseline.

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

    Eligibility last updated 12/16/22. Questions regarding updates should be directed to the study team contact.

    Biologic/Vaccine, Other
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    Contrast Enhanced Breast PCD-CT Compared to MR or mammogram for Staging of Breast Cancer in the Breast and Regional Nodes

    Breast MR

    Tiffany Sae-Kho
    Female
    18 years to 99 years old
    Not Applicable
    This study is NOT accepting healthy volunteers
    2021-305687-H01-RST
    21-008825
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    Inclusion Criteria:

    • Adult female patients 18 to 99 years of age.
    • Patients with proven breast cancer and nodal metastases referred for staging breast MR within the Department of Radiology.
    • Patients who are able and willing to sign the informed consent.
    • Negative pregnancy test if subject is of child-bearing age (females of child-bearing potential will be screened for pregnancy using a urine pregnancy test, which will be administered by the unit study coordinator at no cost to the patient).


    Exclusion Criteria:

    • Minors under 18 years of age.
    • Patients unable to provide written informed consent.
    • Pregnancy.
    • eGFR ≤ 30 (4,5).
    • History of prior moderate or severe contrast reaction including unresponsiveness, severe respiratory distress, convulsions, arrhythmia, cardiopulmonary distress, progressive angioedema, laryngeal edema, dyspnea, bronchospasm, symptomatic tachycardia, symptomatic bradycardia, hypotension, hypertensive crisis.
    • Any history of premedication prior to iodinated contrast.
    • Patients that consent to participation but do not undergo their clinically indicated MR scanning for any reason (e.g., bad IV, infiltration, reaction, change in indication).

    Eligibility last updated 8/24/21. Questions regarding updates should be directed to the study team contact.

     

     

    Behavioral, Device
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    Patient Derived Preclinical Models

    Patient Derived Preclinical Models

    Aaron Mansfield
    All
    18 years and over
    Not Applicable
    This study is NOT accepting healthy volunteers
    2021-305691-H01-RST
    21-008831
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    Inclusion Criteria:

    • 18 years of age and older.
    • Patient is a good medical candidate for a standard of care or research biopsy or surgical procedure to obtain tissue.


    Exclusion Criteria:

    • Individuals < 18 years of age.
    • Uncontrolled concurrent illness including psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent.
    • Inaccessible tumor for biopsy or patient does not have tumor tissue available for research use.
    • Biopsy must not be considered to be more than minimal risk to the patient.
    • Have a contraindication to percutaneous biopsy including:
      • Significant coagulopathy that cannot be adequately corrected;
      • Severely compromised cardiopulmonary function or hemodynamic instability;
      • Lack of a safe pathway to the lesion per the interventional radiologist;
      • Inability of the patient to cooperate with, or to be positioned for, the procedure.

    Eligibility last updated 8/23/21. Questions regarding updates should be directed to the study team contact.

     

     

    Procedure/Surgery
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    Immune Profiling in Kidney Transplant Recipients and Living Kidney Donors

    Immune Profiling of Kidney Transplant Recipients and Living Kidney Donors

    Mark Stegall
    All
    18 years and over
    This study is NOT accepting healthy volunteers
    2021-305694-H01-RST
    21-008777
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    Inclusion Criteria:

    • Individuals ≥ 18 years of age.
    • Adult kidney transplant recipients awaiting transplant, kidney transplant recipients and living kidney donors.


    Exclusion Criteria:

    • Subjects under 18 years of age.

    Eligibility last updated 9/28/21. Questions regarding updates should be directed to the study team contact.

     

     

     

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    Undiagnosed Tumor/Undifferentiated Mass Registry (Undiagnosed Tumor/Undifferentiated Mass Registry)

    Undiagnosed Tumor/Undifferentiated Mass Registry

    Elizabeth Gilman
    All
    18 years and over
    This study is NOT accepting healthy volunteers
    2021-305704-P01-RST
    21-008859
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    Inclusion Criteria:
      

    • Patient presenting to a General Internal Medicine Service.
    • Patient in one of the 3 Mayo Clinic Campuses (Rochester, Arizona, Florida).
    • Patient with an undiagnosed mass: New or enlarging lymph nodes clinically or on imaging:
      • New mass on imaging of soft tissues, bone, spleen, adrenal gland, retroperitoneum, or intraabdominal location without clear organ association .
    • Patient has understood and signed the informed consent to participate in the registry.
    • Patient has the ability to complete all aspects of registry enrollment.
    • Aged 18 and older.

     


    Exclusion Criteria:
       

    • Mass involving the breast, brain, kidney, lung, ovary/adnexa, liver, pancreas, sinus, throat, or thyroid gland will be addressed by the respective specialty areas.  
    • Patients with a known history of any condition or factor judged by the investigator to preclude participation in the registry or which might hinder adherence.
    • Lacking the capacity to consent.
    • Prisoners or institutionalized individuals.
    • Pregnant women.

    Eligibility last updated 9/17/21. Questions regarding updates should be directed to the study team contact.

     

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    Mayo Clinic — Rochester, MN

    The PATHFINDER 2 Study: Evaluating the Safety and Performance of the GRAIL Multi-Cancer Early Detection Test in an Eligible Screening Population (Pathfinder 2)

    PATHFINDER 2: A Multi-Cancer Early Detection Study

    Karthik Giridhar
    All
    50 years and over
    Not Applicable
    This study is NOT accepting healthy volunteers
    2021-305712-P01-RST
    21-009209
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    Inclusion Criteria:


    1. Participants must be at least 50 years of age, inclusive, at the time of signing the
    Informed Consent Form (ICF).

    2. Participants must be capable of giving signed and legally effective informed consent


    Exclusion Criteria:


    1. Undergoing or referred for diagnostic evaluation due to clinical suspicion for cancer
    (e.g., referred to a medical or surgical oncologist, or scheduled for biopsy on the
    basis of a suspicious imaging abnormality).

    2. Personal history of invasive solid tumor or hematologic malignancy, diagnosed within
    the 3 years prior to expected enrollment date, or diagnosed greater than 3 years prior
    to expected enrollment date and never treated.

    - Individuals with a diagnosis of non-metastatic basal cell carcinoma and squamous
    cell carcinoma of the skin are not excluded.

    3. Prior/Concurrent Concomitant Therapy (Medications/Treatments):

    - Definitive treatment for invasive solid tumor or hematologic malignancy within
    the 3 years prior to expected enrollment date. Adjuvant hormone therapy for
    cancer (e.g. for breast or prostate cancer) is not an exclusion criterion.

    4. Individuals who will not be able to comply with the protocol procedures.

    5. Individuals who are not currently registered patients at a participating center.

    6. Previous or current participation in another GRAIL-sponsored study. "Participation" is
    defined as having signed consent and provided a blood sample.

    7. Previous or current employees or contractors of GRAIL.

    8. Current pregnancy (by self-report of pregnancy status)

    Eligibility last updated6/7/22. Questions regarding updates should be directed to the study team contact.

    Diagnostic Test, Device
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    Clinical Utility of Eosinophil-Derived Neurotoxin (EDN) in Asthma Diagnosis and Evaluation (EDN)

    Eosinophil/Asthma Study

    Melissa Snyder
    All
    1 years and over
    This study is NOT accepting healthy volunteers
    2021-305715-H01-RST
    21-008894
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    Inclusion Criteria
    •Study Arm 1 Preschool Children < 6 years old 
    Asthma Group (N=200) :

    • Diagnosis of asthma.
    • In the absence of an asthma diagnosis:
      • Persistent wheezing of at least one year;
      • Even distribution of socio-demographics including age, gender, race and ethnicity.


    Exclusion Criteria:

    • Actively sick with covid or flu.

    Inclusion Criteria
    •Non-Asthma/Disease Controls (N=200)
     :

    • Diagnosis of allergy.
    • Even distribution of sociodemographics including age, gender, race and ethnicity.


    Exclusion Criteria:

    • Diagnosis of asthma.
    • Recurrent wheezing.
    • Actively sick with covid or flu.

    Inclusion Criteria
    •Healthy Controls (N=200)
     

    • Not having or suspected of having any known upper/lower respiratory disease.
    • Even distribution of sociodemographics including age, gender, race and ethnicity.


    Exclusion Criteria:

    • Diagnosis of asthma or any known upper/lower respiratory disease.
    • Diagnosis of allergy.
    • Actively sick with covid or flu.

    Inclusion Criteria
    •Study Arm 2 Children 6-17 years of age 
    Asthma Group (N=200) :

    • Diagnosis of asthma.
    • In the absence of an asthma diagnosis:
      • Persistent wheezing of at least one year.
    • Even distribution of sociodemographics including age, gender, race and ethnicity.


    Exclusion Criteria:

    • Actively sick with covid or flu.  

    Inclusion Criteria
    •Non-Asthma/Disease Controls  (N=200)
     :

    • Diagnosis of allergy. 
    • Even distribution of sociodemographics including age, gender, race and ethnicity.


    Exclusion Criteria:
     

    • Diagnosis of asthma.
    • Recurrent wheezing.
    • Actively sick with covid or flu.

    Inclusion Criteria
    •Healthy Controls  (N=200)
     :

    •  Not having or suspected of having any known upper/lower respiratory disease.
    • Even distribution of sociodemographics including age, gender, race and ethnicity. 


    Exclusion Criteria:
     

    • Diagnosis of asthma or recurrent wheezing.
    • Diagnosis of allergy.
    • Actively sick with covid or flu.

    Inclusion Criteria
    •Study Arm 3  Adults > 18 years old
    Asthma Group (N=200)
     :

    • Diagnosis of asthma.
    • Even distribution of sociodemographics including age, gender, race and ethnicity. 


    Exclusion Criteria:
     

    • Actively sick with covid or flu.  

    Inclusion Criteria
    •Non-Asthma/Disease Controls (N=200)
     :

    • Diagnosis of allergy.
    • Even distribution of sociodemographics including age, gender, race and ethnicity. 


    Exclusion Criteria:

    • Diagnosis of asthma.
    • Recurrent wheezing.
    • Actively sick with covid or flu.

    Inclusion Criteria
    •Healthy Controls  (N=200)
     :

    •  Not having or suspected of having any known upper/lower respiratory disease.
    • Even distribution of socio-demographics including age, gender, race and ethnicity.

    Exclusion Criteriao: 

    • Diagnosis of asthma.
    • Diagnosis of allergy.
    • Actively sick with covid or flu.

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

     

     

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    Mayo Clinic — Rochester, MN

    GS-US-586-6144, A Phase 2 Study of Magrolimab Combination Therapy in Patients With Unresectable, Locally Advanced or Metastatic Triple-Negative Breast Cancer (GS-US-586-6144)

    Study of Magrolimab Combination Therapy to Treat Unresectable, Locally Advanced or Metastatic Triple-Negative Breast Cancer

    Roberto Leon Ferre
    All
    18 years and over
    Phase 2
    This study is NOT accepting healthy volunteers
    2021-305726-P01-RST
    21-008934
    Show full eligibility criteria
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    Inclusion Criteria:

    • Patient has provided informed consent
    • Patient is willing and able to comply with clinic visits and procedures outlined in the study protocol
    • Male or female, at least 18 years of age
    • Patients must have an ECOG performance status of 0 or 1.
    • Laboratory measurements, blood counts:
      • Hemoglobin must be ≥ 9 g/dL prior to initial dose of study treatment. Red blood cell
        (RBC) transfusions are allowed to meet hemoglobin eligibility within limits set per
        Exclusion Criterion #4 
      • Absolute neutrophil count (ANC) at least 1.5 x 10^9/L without growth factor support
        within 2 weeks of study treatment initiation
      • Platelets at least 100 x 10^9/L
    • Laboratory measurements, renal function:
      • Patients must have adequate renal function as demonstrated by a creatinine clearance of at least 30 mL/min; calculated by the Cockcroft Gault formula
    • Adequate liver function, as demonstrated by:
      • AST less than or equal to 2.5 x ULN or less than or equal to 5 x ULN in patients with liver metastases
      • ALT less than or equal to 2.5 x ULN or less than or equal to 5 x ULN in patients with liver metastases
      • Bilirubin less than or equal to 1.5 x ULN, or less than or equal to 3.0 x ULN and primarily unconjugated if patient has a documented history of Gilbert’s syndrome or genetic equivalent
    • Pretreatment blood cross-match completed (Section 7.8.1.1)
    • Male and female patients of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in Appendix 5.
    • Measurable disease according to response evaluation criteria in solid tumors (RECIST),Version 1.1. Previously irradiated lesions can be considered as measurable disease only if disease progression has been unequivocally documented at that site since radiation.
    • Patients must have a life expectancy of 3 months or greater, in the opinion of the investigator.

    Safety Run-in Cohort 1 and Phase 2 Cohort 1
    In addition to meeting the inclusion criteria for all patients, patients who are enrolled into Safety
    Run-in Cohort 1 and Phase 2 Cohort 1 must fulfill the following cohort-specific inclusion
    criteria:

    • Patients previously untreated for unresectable locally advanced or mTNBC that is histologically or cytologically confirmed based on the most recent analyzed biopsy or other pathology specimen, defined as negative for estrogen receptor (ER), progesterone receptor (PR), and Human Epidermal Growth Factor Receptor 2 (HER2) according to the most recent American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guideline (Appendix 9).
    • Patients whose tumors are considered PD-L1 negative, as determined by an approved test according to local standards.
    • Prior systemic treatment for neoadjuvant and/or adjuvant therapy and/or curative intent radiation therapy is permitted if completed at least 6 months prior to enrollment.

    Note: Maintenance therapies are not counted as separate lines of therapy.

    Safety Run-in Cohort 2 and Phase 2 Cohort 2
    In addition to meeting the inclusion criteria for all patients, patients who are enrolled into Safety
    Run-in Cohort 2 and Phase 2 Cohort 2 must fulfill the following cohort-specific inclusion
    criterion:

    • Patients with unresectable, locally advanced or mTNBC that is histologically or cytologically confirmed based on the most recent analyzed biopsy or other pathology specimen, defined as negative for ER, PR, and HER2 according to the most recent ASCO/CAP guideline (Appendix 9), who have received 1 prior line of therapy in the unresectable, locally advanced/metastatic setting. Patients must have been previously treated with a taxane in the neoadjuvant, adjuvant, or locally advanced/metastatic setting
    • Patients with tumors considered positive for PD-L1 expression (as determined by an approved test according to local standards) must have received an immune checkpoint inhibitor for 1L treatment of locally advanced/metastatic disease


    Exclusion Criteria:

    • Positive serum pregnancy test.
    • Breastfeeding female.
    • Active central nervous system (CNS) disease. Patients with asymptomatic and stable, treated CNS lesions (radiation and/or surgery and/or other CNS-directed therapy who have not received corticosteroids for at least 4 weeks) are allowed.
    • Red blood cell (RBC) transfusion dependence, defined as requiring more than 2 units of packed RBC transfusions during the 4-week period prior to screening. RBC transfusions are permitted during the screening period and prior to enrollment to meet the hemoglobin inclusion criteria.
    • History of hemolytic anemia, autoimmune thrombocytopenia, or Evans syndrome in the last 3 months.
    • Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient.
    • Prior treatment with cluster of differentiation 47 (CD47) or signal regulatory protein alpha-targeting agents.
    • Current participation in another interventional clinical trial.
    • Known inherited or acquired bleeding disorders.
    • Significant disease or medical conditions, as assessed by the investigator and sponsor, that would substantially increase the risk-benefit ratio of participating in the study. This includes, but is not limited to, acute myocardial infarction within the last 6 months, unstable angina, uncontrolled diabetes mellitus, significant active infections, and congestive heart failure New York Heart Association Class III-IV
    • Second malignancy, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which patients are not on active anticancer therapies and who are in complete remission for over 2 years.
    • Known active or chronic hepatitis B or C infection or human immunodeficiency virus infection in medical history).
    • Prior anticancer therapy including but not limited to chemotherapy, immunotherapy, or investigational agents within 4 weeks prior to magrolimab is not permitted.
    • Uncontrolled pleural effusion.
    • Uncontrolled hypercalcemia (ionized calcium >1.5 mmol/L) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy.
    • Uncontrolled tumor-related pain.
    • Severe/serious systemic infection within 4 weeks of randomization.
    • Rapid deterioration during screening prior to enrollment (eg, significant change in performance status, 20% or greater decrease in serum albumin levels or uncontrolled tumorrelated pain)
    • Other concurrent medical or psychiatric conditions that, in the investigator’s opinion, may be likely to confound study interpretation or prevent completion of study procedures and followup
      examinations
    • Prior anticancer therapy including but not limited to chemotherapy, immunotherapy, or investigational agents within 4 weeks prior to magrolimab is not permitted
    • Patients who have received a live vaccine within 30 days of randomization
       

    Safety Run-in Cohort 1 and Phase 2 Cohort 1
    Patients who meet the following exclusion criterion are not eligible to be enrolled into Safety
    Run-in Cohort 1 or Phase 2 Cohort 1:

    • Disease progression within 6 months following neoadjuvant/adjuvant therapy or rapid visceral progression and/or symptomatic disease, where single-agent chemotherapy would not be appropriate.

    NOTE: Localized non-CNS radiotherapy, previous hormonal therapy with luteinizing hormonereleasing
    hormone agonists for breast cancer, and treatment with bisphosphonates and receptor
    activator of nuclear factor kappa B ligand inhibitors are not criteria for exclusion. There is no
    required minimum washout period for these therapies. Patients should be recovered from the
    effects of radiation.

    Safety Run-in Cohort 2 and Phase 2 Cohort 2
    Patients who meet any of the following exclusion criteria are not eligible to be enrolled into
    Safety Run-in Cohort 2 or Phase 2 Cohort 2:

    • Patients with active chronic inflammatory bowel disease (ulcerative colitis, Crohn disease) and patients with a history of bowel obstruction or gastrointestinal perforation within 6 months of enrollment
    • Patients who previously received topoisomerase I inhibitors or antibody-drug conjugates containing a topoisomerase inhibitor
    • High-dose systemic corticosteroids (≥ 20 mg of prednisone or its equivalent) are not allowed within 2 weeks of Cycle 1 Day 1
    • Have not recovered (ie, ≥ Grade 2 is considered not recovered) from AEs due to a previously administered agent
      • Note: patients with any grade neuropathy or alopecia are an exception to this criterion and will qualify for the study
      • Note: if patients received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy

    NOTE: Localized non-CNS radiotherapy, previous hormonal therapy with luteinizing hormonereleasing hormone agonists for breast cancer, and treatment with bisphosphonates and receptor activator of nuclear factor kappa B ligand inhibitors are not criteria for exclusion. There is no required minimum washout period for these therapies. Patients should be recovered from the effects of radiation.

    Eligibility last updated 2/18/22. Questions regarding updates should be directed to the study team contact.

     

    Biologic/Vaccine, Drug
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    A Phase 2a Study of TPN-101 in Patients with C9ORF72 ALS/FTD (Amyotrophic Lateral Sclerosis and/or Frontotemporal Dementia) (TPN-101)

    A Phase 2a Study of TPN-101 in Patients With C9ORF72 ALS/FTD

    Bradley Boeve
    All
    18 years and over
    Phase 2
    This study is NOT accepting healthy volunteers
    2021-305733-P01-RST
    21-009164
    Show full eligibility criteria
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    Inclusion Criteria:


    - Have documentation of a clinical genetic test demonstrating the presence of a
    confirmed repeat expansion in the C9orf72 gene from a CLIA certified laboratory

    - Score ≥ 18 on the Mini-Mental State Exam (MMSE) at Screening

    - Have a reliable caregiver to accompany the patient to all study visits.

    - For patients with ALS (with or without FTD):

    - Diagnosis of ALS (probable, possible, laboratory-supported probable or definite)
    according to the World Federation of Neurology revised E1 Escorial criteria

    - Onset of weakness within 3 years prior to Screening

    - Slow vital capacity (SVC) ≥ 60% of predicted normal adjusted for sex, age, and
    height (from the sitting position)

    - ALS Functional Rating Scale-Revised (ALSFRS-R) ≥ 30 at Screening

    - For patients with FTD:

    - A gradual, progressive decline in behavior, language, or motor function
    consistent with C9ORF72 hexanucleotide expansion-related syndrome such as
    behavioral variant FTD, primary progressive vaphasia, or amnestic syndrome

    - CDR Dementia Staging Instrument plus National Alzheimer's Coordinating Center
    Behavior and Language Domains (CDR plus NACC FTLD) global score of 0.5-2.0 at
    Screening


    Exclusion Criteria:


    - Presence of other significant neurological or psychiatric disorders

    - History of significant brain abnormality, including, but not limited to, prior
    hemorrhage or infarct, cerebral contusion, encephalomalacia, aneurysm, vascular
    malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g., abscess
    or brain tumor such as meningioma); symptoms or signs of elevated intracranial
    pressure, e.g., symptoms or history of head injury or abnormal funduscopic exam. If
    there is history or evidence on neurologic exam suggesting possible subdural hematoma
    (SDH), patients should be fully evaluated, including magnetic resonance imaging (MRI)
    if indicated, to exclude significant, new SDH

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    MC210706 Efficacy and Safety Study of Neoadjuvant Efineptakin alfa (NT-I7) Plus Pembrolizumab in Recurrent Glioblastoma

    Efineptakin alfa (NT-I7) Plus Pembrolizumab for the Treatment of Recurrent Glioblastoma

    Jian Campian
    All
    18 years and over
    Phase 2
    This study is NOT accepting healthy volunteers
    2021-305737-P01-RST
    21-011200
    Show full eligibility criteria
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    Inclusion Criteria:

    • Age ≥ 18 years.
    • Progressive or recurrent WHO Grade IV IDH wildtype glioblastoma (including molecular glioblastoma and gliosarcoma).
    • Have an enhancing mass on MRI amenable to resection or biopsy of the tumor (as determined by the neurosurgeon pre-operatively) and histological diagnosis of glioblastoma from a prior biopsy or surgery.
    • Willing to undergo resection or biopsy of their glioblastoma at Mayo Clinic in Rochester, MN.
    • ECOG Performance Status (PS) of 0 or 1 and KPS ≥ 70.
      • Note: PS must be assessed again within 7 days prior to first dose of study drug.
    • The following laboratory values obtained ≤ 15 days prior to registration:
      • Absolute neutrophil count (ANC) ≥ 1500/mm^3;
      • Platelet count ≥ 100,000/mm^3;
      • Hemoglobin ≥ 9.0 g/dL without transfusion or EPO dependency (≤ 7 days prior to assessment);
      • Creatinine ≤ 2.0 x ULN OR measured or calculated creatinine clearance (per institutional standard) must be ≥ 45 ml/min;
      • Total bilirubin ≤ 1.5 x ULN OR Direct bilirubin ≤ULN for patients with total bilirubin levels > 1.5 x ULN;
      • Aspartate transaminase (AST) AND alanine transaminase (ALT) ≤ 2.5 x ULN;
      • INR/PT/aPTT ≤ 1.5 × ULN OR if patient is receiving anticoagulant therapy then INR or aPTT is within target range of therapy.
    • Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only (POCBP).
      • Note: If testing done for eligibility is > 72 hours prior to first dose, then pregnancy testing must be repeated, and result must be negative for patient to receive treatment.
    • POCBP or able to father a child must be willing to use adequate contraception starting with first dose through 120 days after last dose. 
    • Provide written informed consent.
    • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
    • Willing to provide tissue and blood samples for correlative research purposes.


    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 or able to father a child who are unwilling to employ adequate contraception.
    • Signs or symptoms of life-threatening raised intracranial pressure: as defined by the treating neurosurgeon, including severe headache, nausea, decreasing level of consciousness, precluding 4-7 day delay in scheduling neurosurgery.
    • Prior treatment.
    • Received bevacizumab (AVASTIN) ≤ 28 days prior to registration.
      Note: Bevacizumab is allowed for symptom control during the adjuvant phase if the study.
    • Received a live vaccine ≤ 30 days prior to registration.
    • Major surgery ≤ 28 days prior to registration.
    • Requirement for dexamethasone dose of > 2mg/day ≤ 2 days prior to registration.
    • 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.
    • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
    • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
    • Other active malignancy requiring systemic treatment ≤ 1 year prior to registration.
    • History of myocardial infarction ≤6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
    • Active autoimmune disease that has required systemic treatment (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) ≤ 2 years prior to registration.
      • Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
    • Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
    • Known history of active TB (Bacillus Tuberculosis).
    • History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
    • Hypersensitivity to pembrolizumab or any of its excipients.
    • Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
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    Enhancing the Natriuretic Peptide System in HFpEF: A Randomized Double-Blind Placebo-Controlled Triple Crossover Study

    Enhancing the Natriuretic Peptide System in HFpEF

    Paul McKie
    All
    18 years and over
    Not Applicable
    This study is NOT accepting healthy volunteers
    2021-305738-H01-RST
    21-008978
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    Inclusion Criteria:

    • Group 1: HFpEF-CKD-will consist of 30 subjects with:
      • Ejection fraction of greater than 55%; and
      • Evidence of increased LV filling pressures, including at least 2 of the following:
      • average septal–lateral E/e’ ratio > 15;
      • tricuspid regurgitation (TR) peak velocity > 2:8 m/s;
      • Left atrial volume index >34mL/m^2 assessed by echocardiography; and
      • Previous diagnosis of HF with New York Heart Association (NYHA) functional class II-III symptoms on chronic loop diuretic therapy; and
      • CKD defined as glomerular filtration rate (eGFR) of 15-60 mL/min/1.73 m^2 as estimated by the Modification of Diet in Renal Disease equation. Subject needs to be on stable dose of chronic loop diuretic for at least 4 weeks prior to study and maintained on the same dose for the duration of the study. In addition to the exclusion criteria listed below, to ensure a more homogenous group of subjects, we will exclude subjects with Diabetes or BMI > 35 (because endogenous natriuretic peptide levels are low in obese subjects).
    • Group 2: HFpEF-EI-will consist of 30 subjects with:
      • Ejection fraction of greater than 55%; and
      • Previous invasive determination of normal pulmonary capillary wedge pressure (< 15 mmHg) at rest and ≥ 25 mmHg during exercise12; and
      • New York Heart Association (NYHA) functional class II-III symptoms but not on chronic loop diuretic therapy; and
      • Glomerular filtration rate (eGFR) of > 60 mL/min/1.73 m^2 as estimated by the Modification of Diet in Renal Disease equation. In addition to the exclusion criteria listed below, to ensure a more homogenous group of subjects, we will exclude subjects with Diabetes or BMI>35 (because endogenous natriuretic peptide levels are low in obese subjects).


    Exclusion Criteria:

    • Age < 18 years.
    • Body mass index > 35.
    • Blood pressure < 100/60 or > 180/100 mmHg.
    • Diabetes.
    • Myocardial infarction within 6 months of screening.
    • Unstable angina within 6 months of screening, or any evidence of myocardial ischemia.
    • Significant valvular heart diseases.
    • Hypertrophic, restrictive or obstructive cardiomyopathy.
    • Constrictive pericarditis.
    • Primary pulmonary hypertension.
    • Biopsy proven active myocarditis.
    • Severe congenital heart diseases.
    • Cardiac amyloidosis.
    • Fabry disease.
    • Sarcoidosis.
    • Sustained ventricular tachycardia or ventricular fibrillation within 14 days of screening.
    • Second or third degree heart block without a permanent cardiac pacemaker.
    • Stroke within 3 months of screening, or other evidence of significantly compromised CNS perfusion.
    • Hemoglobin < 9 g/dl.
    • ALT > 2 times the upper limit of normal; serum sodium of  < 135 mEq/dL or > 150 mEq/dL.
    • Serum potassium of < 3.5 mEq/dL or > 5.7 mEq/dL.
    • Bother acute or chronic medical conditions or laboratory abnormality which may increase the risks associated with study participation or may interfere with interpretation of the data.
    • Received an investigational drug within 1 month prior to dosing.
    • Patients with an allergy to iodine; female subject who is pregnant or breastfeeding.
    • In the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for any reasons.

    Eligibility last updated 3/16/22. Questions regarding updates should be directed to the study team contact.

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    A Phase 2, Two-part, Placebo-controlled, Parallel-group, Double-blind Study to Assess the Efficacy and Safety of 2 Dosage Regimens of Oral IPN60130 for the Treatment of Fibrodysplasia Ossificans Progressiva in Male and Female Participants 5 years of Age and Older (IPN60130)

    A Study Assessing the Efficacy and Safety of 2 Dosage Regimens of Oral IPN60130 for FOP

    Robert Pignolo
    All
    5 years and over
    Phase 2
    This study is NOT accepting healthy volunteers
    2021-305740-P01-RST
    21-008980
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    Key

    Inclusion Criteria:


    - Written, signed, and dated informed subject/parent consent; and for subjects who are
    minors, age-appropriate assent (performed according to local regulations).

    - Participants must be clinically diagnosed with FOP, with the R206H ACVR1 mutation or
    other FOP variants associated with progressive HO.

    - Participants must have disease progression in the preceding year of the screening
    visit.

    - Participants who have participated in a prior clinical study using another
    investigational product for the treatment of FOP may be enrolled after a washout of at
    least 5 half-lives of the other investigational product. Participants with prior
    treatment such as, but not limited to, imatinib, isotretinoin, garetosmab or
    palovarotene may be enrolled 30 days after discontinuation or after washout of at
    least 5 half-lives, whichever is longer.

    - Participants must be able to perform pulmonary function tests adequately and reliably.

    - Participants must be able to have an adequate echocardiography assessment at screening
    for evaluation of left ventricular structure and function as defined by the protocol.

    - Participants must be accessible for treatment and follow-up and be able to undergo all
    study procedures. Participants living at distant locations from the investigational
    site must be able and willing to travel to a site for the initial and all on-site
    follow-up visits. Participants must be able to undergo low-dose WBCT (excluding head)
    without sedation.

    - Body weight ≥10 kg.

    - Abstinent or using two highly effective forms of birth control. Females must also have
    a negative blood or urine pregnancy test prior to administration of study drug.

    Key
    Exclusion Criteria:


    - Participants with complete heart block and left bundle branch block on screening
    electrocardiogram.

    - Participants with screening echocardiography showing septal or left ventricular free
    wall thickness >12 mm for adult participants or a z-score >3 compared with population
    norms for children and adolescent participants or left ventricular ejection fraction
    (LVEF) <50%.

    - Participants with severe mitral or tricuspid regurgitation on echocardiography at
    screening.

    - Participants with significant underlying lung disease requiring supplementary oxygen
    or forced vital capacity <35% of predicted at screening.

    - Participants with uncontrolled cardiovascular, hepatic, pulmonary, gastrointestinal,
    endocrine, metabolic, ophthalmologic, immunologic, psychiatric, or another significant
    disease as judged by the investigator.

    - Participants with severe hepatic impairment.

    - Concomitant medications that are strong inhibitors (including grapefruit juice) or
    inducers (including St John's Wort) of cytochrome P450 (CYP) 3A4 activity; or kinase
    inhibitors such as imatinib.

    - Prior use in the past year and concomitant use of bisphosphonates for participants in
    the PET-CT sub study.

    - Concurrent participation in another interventional clinical study, or a
    noninterventional study with radiographic measures or invasive procedures (e.g.
    collection of blood or tissue samples).

    - Amylase or lipase >2× the upper limit of normal (ULN) or with a history of chronic
    pancreatitis.

    - Elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5×ULN.

    - Participants with hematologic abnormalities:

    - Hgb<10g/dL

    - Platelets<75,000/mm3

    - WBC<2000/mm3

    - Participants with coagulation test measurements outside of the normal range at
    screening.

    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.

    Drug, Other
    BLU-782, Progressive myositis ossificans
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    Mayo Clinic — Rochester, MN

    A2B101-1, BASECAMP-1: Observational Protocol Obtaining Solid Tumor Tissue from Subjects with Primary Surgical Resection and Leukapheresis for CAR T-Cell Therapy Manufacturing

    A2B101-101: Obtaining Primary Solid Tumor Tissue from Subjects Having Primary Surgical Resection for Certain Tumor Types and Leukapheresis for CAR T-cell Therapy Manufacturing

    Julian Molina
    All
    18 years and over
    This study is NOT accepting healthy volunteers
    2021-305746-P01-RST
    21-009252
    Show full eligibility criteria
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    Inclusion Criteria
    •Part 1:

    • Able to provide written informed consent.
    • Pathologically confirmed solid tumors; e.g., Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), Pancreatic Cancer, Gastric and Esophageal Cancer, Ovarian Cancer, Mesothelioma, Breast Cancer, or Head and Neck Cancer and in the Investigator’s opinion the subject is high risk for incurable relapse within two years.
    • Age ≥ 18 years.

    Exclusion Criteria
    •Part 1:

    • History of any of other malignancy in the past 5 years other than non-melanoma skin carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ (CIS) of the breast, CIS of the Cervix, or Stage I uterine cancer.
    • Prior allogeneic stem cell transplant.
    • Prior solid organ transplant.
    • In the investigator’s judgement, the subject is unlikely to complete all protocol required study visits, including hospitalization, study visits and procedures, and follow up visits, or comply with the study requirements for participation. 

    Eligibility Criteria
    •Part 2:

    • Able to provide written informed consent.
    • Pathologically confirmed solid tumors; e.g., Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), Pancreatic Cancer, Gastric and Esophageal Cancer, Ovarian Cancer, Mesothelioma, Breast Cancer, or Head and Neck Cancer and in the Investigator’s opinion the subject is high risk for incurable relapse within two years.
    • Age ≥ 18 years.
    • Subjects are germline HLA-A*02 heterozygous confirmed by HLA typing.
    • Primary tumor tissue showing LOH of HLA-A*02 by NGS.
    • Adequate bone marrow reserve, hematological, renal and hepatic function defined as: 
      • Hemoglobin > 9.0 g/dL;
      • ANC 800/µl;
      • Platelet count > 80,000/µl;
      • Serum Creatinine <1.5 x ULN;
      • Calculated Creatinine Clearance > 60 ml/min;
      • Total Serum Bilirubin < 2 x ULN;
      • ALT< 5 x ULN;
      • AST< 5 x ULN.
    • Eastern Cooperative Oncology Group (ECOG) performance status < 1.
    • Baseline oxygen saturation > 92% on room air.
    • No clinically significant pleural effusion.

    Exclusion Criteria
    •Par 2:

    • History of any of other malignancy in the past 5 years other than non-melanoma skin carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ (CIS) of the breast, CIS of the Cervix, or Stage I uterine cancer.
    • Prior allogeneic stem cell transplant.
    • Prior solid organ transplant.
    • Presence of any indwelling catheter or drain (e.g., percutaneous nephrostomy tube, indwelling foley catheter, biliary drain, or pleural/peritoneal, pericardial catheter).  Ommaya reservoirs and dedicated central venous access catheters such as a Port-a-Cath or Hickman catheter are permitted.
    • Subjects who have received any cancer therapy (investigational agent or not), including but not limited to chemotherapy, small molecules, monoclonal antibodies, or radiotherapy (with bone marrow impact) within 3 weeks of planned leukapheresis or 5 half-lives, whichever is shorter.
    • Has a diagnosis of immunodeficiency or autoimmune disease requiring continued systemic therapy (e.g., monoclonal antibody therapy).
    • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment necessitating specific treatment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to completion of antibiotic course).
    • Has known active central nervous system metastases. Subjects with previously treated brain metastases may participate upon sponsor agreement.
    • Known or suspected chronic, active Epstein Barr Virus (EBV).
    • Has known active history of or screened positive for Human Immunodeficiency Virus (HIV).
    • Has known active history of or screened positive for Hepatitis B (HBsAg positive) or C (anti-HCV positive).
    • Unstable angina, myocardial infarction, cardiac angioplasty or stenting, or any other significant cardiac disease within the last 6 months.
    • History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment.
    • Requires supplemental home oxygen.
    • Significant pulmonary disease (e.g., idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or obstructive pulmonary disease).
    • Females of childbearing potential who are pregnant or breastfeeding.
    • In the investigator’s judgement, the subject is unlikely to complete all protocol required study visits, including hospitalization, study visits and procedures, and follow up visits, or comply with the study requirements for participation. 

    Eligibility last updated 11/10/21. Questions regarding updates should be directed to the study team contact.

     

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