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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
Must not have
Has failed to recover from the reversible effects of prior anticancer therapy
Has uncontrolled or poorly controlled hypertension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I still have side effects from previous cancer treatments that haven't gone away.
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My blood pressure is very high and not well-managed.
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I am currently on blood thinner medication.
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I have not had major surgery in the last 3 months.
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I have untreated brain metastases or a history of leptomeningeal disease or spinal cord compression.
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I have been treated with belzutifan or similar drugs before.
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I received radiation for bone metastases less than 2 weeks ago.
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I have been treated with cabozantinib before.
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I am currently being treated for an infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Response Rate (ORR)
Secondary study objectives
Belzutifan Metabolite Plasma Concentration
Belzutifan Plasma Concentration
Cabozantinib Plasma Concentration
+6 more

Awards & Highlights

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.

Trial 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
2,885 Previous Clinical Trials
8,088,654 Total Patients Enrolled

Media Library

Belzutifan (HIF-2alpha Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03634540 — Phase 2
Renal Cell Carcinoma Research Study Groups: Belzutifan + Cabozantinib: Treatment Naïve (Cohort 1), Belzutifan + Cabozantinib: Prior Immunotherapy (Cohort 2)
Renal Cell Carcinoma Clinical Trial 2023: Belzutifan Highlights & Side Effects. Trial Name: NCT03634540 — Phase 2
Belzutifan (HIF-2alpha Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03634540 — Phase 2
~13 spots leftby Aug 2025
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