Belzutifan + Cabozantinib for Kidney Cancer

Recruiting in Palo Alto (17 mi)

+9 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Peloton Therapeutics, Inc.

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is an open-label Phase 2 study which will evaluate the efficacy and safety of belzutifan in combination with cabozantinib in participants with advanced ccRCC. Belzutifan and cabozantinib will be administered orally once daily.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

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.

Inclusion Criteria

Your AST and ALT levels in your blood are not more than 3 times the normal limit.

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.

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Exclusion Criteria

Is participating in another therapeutic clinical trial

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.

See 9 more

Treatment Details

Interventions

Belzutifan (HIF-2alpha Inhibitor)
Cabozantinib (Tyrosine Kinase Inhibitor)

Trial OverviewThe 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.

Participant Groups

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.