Belzutifan + Cabozantinib for Kidney Cancer

Palo Alto (17 mi)

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.

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

My kidney cancer is advanced or has spread and is mainly clear cell type.

My blood tests show normal white blood cells, hemoglobin, and platelets.

My total bilirubin level is 1.5 mg/dL or lower.

I am fully active or can carry out light work.

I have not had any systemic therapy for advanced kidney cancer.

Exclusion Criteria

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.

I have not had major surgery in the last 3 months.

I have untreated brain metastases or a history of leptomeningeal disease or spinal cord compression.

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.

Treatment Details

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.

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.

Belzutifan is already approved in United States for the following indications:

🇺🇸 Approved in United States as Welireg for:

Advanced renal cell carcinoma (RCC) following a PD-1 or PD-L1 inhibitor and a VEGF TKI
Von Hippel-Lindau disease-associated RCC, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors