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HIF-2alpha Inhibitor
Belzutifan + Cabozantinib for Kidney Cancer
Phase 2
Waitlist Available
Research Sponsored by Peloton Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has locally advanced or metastatic RCC with predominantly clear cell subtype
Has adequate organ function including absolute neutrophil count ≥ 1,000/µL, hemoglobin level ≥ 10 g/dL, and platelet count ≥ 100,000/µL without transfusion or growth factor support within 2 weeks prior to obtaining the hematology values at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years
Awards & highlights
Study Summary
This trial will study the effects of two drugs, belzutifan and cabozantinib, when taken together by people with advanced kidney cancer. The drugs will be taken orally once daily.
Who is the study for?
This trial is for adults with advanced clear cell renal cell carcinoma (ccRCC). Participants should have measurable tumors, good performance status, and proper organ function. Some can't join if they've had certain treatments for ccRCC or major surgery recently, uncontrolled hypertension, active infections needing treatment, or are in another clinical trial.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of combining two oral drugs: Belzutifan and Cabozantinib. It's an open-label Phase 2 study where all participants know which treatment they're getting and take the medications daily to treat advanced kidney cancer.See study design
What are the potential side effects?
Potential side effects from Belzutifan and Cabozantinib may include high blood pressure, fatigue, mouth sores, hand-foot syndrome (redness and pain on palms or soles), diarrhea, decreased appetite, weight loss, nausea/vomiting. Each person's experience with side effects might vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney cancer is advanced or has spread and is mainly clear cell type.
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My blood tests show normal white blood cells, hemoglobin, and platelets.
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My total bilirubin level is 1.5 mg/dL or lower.
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I am fully active or can carry out light work.
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I have not had any systemic therapy for advanced kidney cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
Belzutifan Metabolite Plasma Concentration
Belzutifan Plasma Concentration
Cabozantinib Plasma Concentration
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Belzutifan + Cabozantinib: Treatment Naïve (Cohort 1)Experimental Treatment2 Interventions
Naïve participants will receive 120 mg belzutifan and 60 mg cabozantinib orally once daily (QD) at the same time.
Group II: Belzutifan + Cabozantinib: Prior Immunotherapy (Cohort 2)Experimental Treatment2 Interventions
Participants who have received prior immunotherapy will receive 120 mg belzutifan and 60 mg cabozantinib orally QD at the same time.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
FDA approved
Belzutifan
FDA approved
Find a Location
Who is running the clinical trial?
Peloton Therapeutics, Inc.Lead Sponsor
7 Previous Clinical Trials
340 Total Patients Enrolled
Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Lead Sponsor
7 Previous Clinical Trials
340 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,789 Previous Clinical Trials
8,067,212 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any major health or mental conditions that could affect my trial participation.I still have side effects from previous cancer treatments that haven't gone away.My blood pressure is very high and not well-managed.I am currently on blood thinner medication.Your AST and ALT levels in your blood are not more than 3 times the normal limit.I have not had major surgery in the last 3 months.My kidney cancer is advanced or has spread and is mainly clear cell type.You have at least one tumor that can be measured according to specific guidelines.My blood tests show normal white blood cells, hemoglobin, and platelets.Your blood creatinine level is not more than double the upper limit of normal.I have untreated brain metastases or a history of leptomeningeal disease or spinal cord compression.I have not had a major heart event in the last 6 months.My total bilirubin level is 1.5 mg/dL or lower.I have had immunotherapy and up to two treatments for advanced kidney cancer.I have been treated with belzutifan or similar drugs before.I received radiation for bone metastases less than 2 weeks ago.I have been treated with cabozantinib before.I am currently being treated for an infection.I am fully active or can carry out light work.I have not had any systemic therapy for advanced kidney cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Belzutifan + Cabozantinib: Treatment Naïve (Cohort 1)
- Group 2: Belzutifan + Cabozantinib: Prior Immunotherapy (Cohort 2)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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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