Belzutifan for Kidney Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial is testing belzutifan, a medication for patients with advanced kidney cancer that hasn't responded to previous treatments. The drug works by blocking a protein that cancer cells need to grow. Researchers aim to find out if it is safe and effective for these patients. Belzutifan has received FDA approval for treating von Hippel-Lindau-associated renal cell carcinoma and has shown significant efficacy in related tumors.

Eligibility Criteria

This trial is for adults with advanced clear cell renal cell carcinoma who've had disease progression after at least one systemic treatment. They must have good organ function, agree to use contraception, and not be pregnant or breastfeeding. Exclusions include those with hypoxia, other active cancers within 3 years (except certain skin/in situ cancers), HIV/hepatitis infections, prior belzutifan treatment, recent anticancer antibodies or radiotherapy, major surgery within 3 weeks, brain metastasis, severe heart/liver conditions or infections.

Inclusion Criteria

My kidney cancer cannot be surgically removed and has spread.

My organs are functioning well.

My kidney cancer has worsened after at least one treatment.

See 2 more

Exclusion Criteria

I have not taken any CSFs within the last 28 days.

I have been treated with belzutifan before.

I have a history of GI issues or liver problems.

See 12 more

Treatment Details

Interventions

Belzutifan (HIF-2alpha Inhibitor)

Trial OverviewThe study tests the safety and effects of different doses of Belzutifan in patients with advanced kidney cancer as a second-line treatment. It aims to understand how the body handles the drug (pharmacokinetics) and its tolerability when given after another therapy has failed.

Participant Groups

4Treatment groups

Experimental Treatment

Group I: Belzutifan 200 mg TIDExperimental Treatment1 Intervention

Participants will receive belzutifan 200 mg orally TID. Treatment will continue until progressive disease or discontinuation.

Group II: Belzutifan 160 mg TIDExperimental Treatment1 Intervention

Participants will receive belzutifan 160 mg orally three times daily (TID). Treatment will continue until progressive disease or discontinuation.

Group III: Belzutifan 160 mg BIDExperimental Treatment1 Intervention

Participants will receive belzutifan 160 mg orally twice daily (BID). Treatment will continue until progressive disease or discontinuation.

Group IV: Belzutifan 120 mg QDExperimental Treatment1 Intervention

Participants will receive belzutifan 120 mg orally once daily (QD). Treatment will continue until progressive disease or discontinuation.

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