Belzutifan + Pembrolizumab for Kidney Cancer

Recruiting in Palo Alto (17 mi)

+298 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Merck Sharp & Dohme LLC

Stay on Your Current Meds

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing a new treatment in patients who have had kidney cancer surgery. The goal is to see if this treatment can prevent the cancer from coming back. One part of the treatment stops cancer cells from surviving in low oxygen, and the other part helps the immune system attack the cancer. This approach has shown improved survival rates in treating advanced kidney cancer.

Eligibility Criteria

This trial is for adults who've had kidney cancer surgery within the last 12 weeks. They should have a certain level of risk for their cancer returning but no current evidence of disease spread, and must be in good physical condition (ECOG 0-1). Participants need proper organ function and can't join if they've had major recent surgeries, severe heart issues, active infections or autoimmune diseases, other cancers within 3 years, or specific lung conditions.

Inclusion Criteria

I will continue using birth control for at least 7 days after my last dose.

I am fully active or restricted in physically strenuous activity but can do light work.

My organs are functioning well.

+8 more

Exclusion Criteria

I have received treatment for kidney cancer before.

I need extra oxygen sometimes or all the time.

My cancer has spread to my brain or bones.

+12 more

Participant Groups

The study tests if taking belzutifan pills with pembrolizumab injections works better than placebo pills with pembrolizumab for preventing kidney cancer from coming back after surgery. The main goal is to see which combination leads to longer periods without the disease returning.

2Treatment groups

Experimental Treatment

Group I: Placebo + PembrolizumabExperimental Treatment2 Interventions

Participants receive placebo orally QD for up to approximately 54 weeks PLUS pembrolizumab 400 mg via IV infusion once Q6W for up to 9 administrations (up to approximately 54 weeks).

Group II: Belzutifan + PembrolizumabExperimental Treatment2 Interventions

Participants receive belzutifan 120 mg orally once daily (QD) for up to approximately 54 weeks PLUS pembrolizumab 400 mg via intravenous (IV) infusion once every 6 weeks (Q6W) for up to 9 administrations (up to approximately 54 weeks).

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