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Tyrosine Kinase Inhibitor
PT2385 for Kidney Cancer
Phase 1
Waitlist Available
Research Sponsored by Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has locally advanced or metastatic ccRCC and has progressed during treatment with at least one prior therapeutic regimen
Received no more than three prior systemic treatment regimens in the advanced or metastatic setting
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, at week 6 and every 9 weeks thereafter up to approximately 1 year
Awards & highlights
Study Summary
This trial is testing a new drug, MK-3795, for patients with advanced kidney cancer. The goal is to find the maximum tolerated dose (MTD) of the drug for future trials.
Who is the study for?
This trial is for adults over 18 with advanced clear cell renal cell carcinoma who've had at least one prior treatment but no more than three, including a specific type of drug targeting blood vessel growth. They must expect to live at least 3 months, be able to take pills, and use approved birth control if necessary. Exclusions include recent major surgery, other clinical trials participation, untreated brain metastases, uncontrolled hypertension, certain heart conditions within the past 6 months.Check my eligibility
What is being tested?
The study tests different doses of MK-3795 alone and in combination with Nivolumab or Cabozantinib to find the highest dose patients can tolerate without severe side effects (MTD) and recommend for future studies (RP2D). It's divided into three parts: testing MK-3795 alone; then with Nivolumab; and finally with Cabozantinib.See study design
What are the potential side effects?
Possible side effects may include typical reactions from cancer treatments such as fatigue, nausea, liver function changes. Since it involves immune therapy drugs like Nivolumab and targeted therapies like Cabozantinib there could also be risks of immune-related inflammation or high blood pressure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney cancer has spread and worsened despite treatment.
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I've had 3 or fewer treatments for my advanced cancer.
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I have had 1 or 2 treatments targeting blood vessel growth in my cancer.
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I have been treated with a medication targeting blood vessel growth in cancer.
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I can take pills by mouth.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, at week 6 and every 9 weeks thereafter up to approximately 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, at week 6 and every 9 weeks thereafter up to approximately 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD)
Recommended Phase 2 Dose (RP2D)
Secondary outcome measures
Accumulation Ratio (RAC)
Antitumor Activity
Apparent Clearance (CL/F) of Study Treatment
+22 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Part 3: MK-3795 + CabozantinibExperimental Treatment2 Interventions
Participants with advanced ccRCC in the expansion phase receive the RP2D of MK-3795 in combination with cabozantinib 20mg up to 60mg orally QD for up to approximately 1 year (12 cycles; each cycle length = 28 days) or until unequivocal progression or treatment discontinuation, whichever occurs later.
Group II: Part 2: MK-3795 + Nivolumab + BelzutifanExperimental Treatment3 Interventions
Participants with advanced ccRCC in the expansion phase receive the RP2D of MK-3795 orally in combination with nivolumab 240mg by IV infusion over ~60 minutes every 2 weeks for up to ~1 year (12 cycles; each cycle length = 28 days) or until unequivocal progression or treatment discontinuation, whichever occurs later. As per Amendment 09 (29 March 2024), participants will not receive MK-3795. Participants receive nivolumab 240mg by IV infusion over ~60 minutes every 2 weeks in combination with belzutifan 120 mg once daily (QD) for up to ~1 year (12 cycles; each cycle length = 28 days) or until unequivocal progression or treatment discontinuation, whichever occurs later. If participants experience an adverse event, then nivolumab will be discontinued and participants will continue to receive belzutifan 120 mg QD alone for up to ~1 year (12 cycles; each cycle length = 28 days) or until unequivocal progression or treatment discontinuation, whichever occurs later.
Group III: Part 1: MK-3795Experimental Treatment1 Intervention
Participants with advanced ccRCC receive MK-3795 at an initial dose level of 100mg orally, twice daily (BID) up to approximately 3 weeks. Dose levels will be escalated to identify the maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D) for MK-3795. Each escalated dose will be continued for up to approximately 3 weeks before escalating a dose again until a dose limiting toxicity (DLT) is experienced. Thereafter, participants receive RP2D dose of MK-3795 for up to 2 cycles (each cycle length = 28 days) for up to approximately 1 year. Participants may continue to receive MK-3795 beyond 1 year at the discretion of the Sponsor.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Cabozantinib
FDA approved
Find a Location
Who is running the clinical trial?
Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Lead Sponsor
7 Previous Clinical Trials
348 Total Patients Enrolled
Peloton Therapeutics, Inc.Lead Sponsor
7 Previous Clinical Trials
348 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,789 Previous Clinical Trials
8,067,220 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have untreated brain metastasis or a history of leptomeningeal disease or spinal cord compression.I still have side effects from previous cancer treatments.I am currently being treated for an infection.I have had a major heart event in the last 6 months.I don't have any major health or mental conditions that could affect my trial participation.You have a current or recent history of a known or suspected autoimmune disease.I have not had major surgery in the last 4 weeks.I am HIV positive.I have a gastrointestinal disorder.My kidney cancer has spread and worsened despite treatment.My blood pressure is high and not well-managed.I have a history of congenital long QT syndrome.I have previously undergone immunotherapy.I've had 3 or fewer treatments for my advanced cancer.I have had 1 or 2 treatments targeting blood vessel growth in my cancer.I have been treated with a medication targeting blood vessel growth in cancer.I am using or agree to use birth control as per my doctor's advice during and after the study.I can take pills by mouth.You are expected to live for at least 3 more months.I am 18 years old or older.I am taking or will need to take warfarin for blood thinning.My organs are functioning well.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1: MK-3795
- Group 2: Part 2: MK-3795 + Nivolumab + Belzutifan
- Group 3: Part 3: MK-3795 + Cabozantinib
Awards:
This trial has 2 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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