Belzutifan for Kidney Cancer

Recruiting in Palo Alto (17 mi)

+48 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This study will compare the efficacy and safety of two doses of belzutifan in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy. The primary hypothesis is that the higher dose of belzutifan is superior to the standard dose in terms of objective response rate (ORR).

Eligibility Criteria

This trial is for adults with advanced renal cell carcinoma who have previously been treated with anti-PD-1/L1 therapy. They must be in good physical condition (KPS score ≥70%), able to use contraception, and not pregnant or breastfeeding. Participants should have no more than three prior treatments for RCC, only one of which can be anti-PD-1/L1 therapy.

Inclusion Criteria

You have a condition that can be measured using specific medical guidelines.

I have had 3 or fewer treatments for advanced kidney cancer.

I am not pregnant or breastfeeding and either cannot become pregnant or agree to use birth control during and after the study.

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Exclusion Criteria

I haven't had cancer treatment with antibodies in the last 4 weeks.

I have been treated with belzutifan or a similar drug before.

Is currently participating in a study of an investigational agent or is currently using an investigational device

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Treatment Details

Interventions

Belzutifan (HIF-2 Alpha Inhibitor)

Trial OverviewThe study tests two different doses of belzutifan to see which one works better for treating advanced renal cell carcinoma after previous therapies. The main goal is to compare the objective response rates between the standard dose and a higher dose.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Belzutifan 200 mgExperimental Treatment1 Intervention

Participants receive 200 mg of belzutifan by oral administration, once a day (QD), until disease progression or discontinuation.

Group II: Belzutifan 120 mgExperimental Treatment1 Intervention

Participants receive 120 mg of belzutifan by oral administration, QD, until disease progression 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