Belzutifan + Lenvatinib vs. Cabozantinib for Kidney Cancer

Recruiting in Palo Alto (17 mi)

+195 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This study will compare the efficacy and safety of belzutifan + lenvatinib versus cabozantinib in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy. The primary hypothesis is that belzutifan + lenvatinib is superior to cabozantinib in terms of progression-free survival or overall survival.

Eligibility Criteria

This trial is for adults with advanced renal cell carcinoma who have seen their cancer progress after anti-PD-1/L1 therapy. They should have measurable disease, a Karnofsky performance status of at least 70%, and no more than two prior systemic treatments. Participants must not be pregnant or breastfeeding and agree to use contraception.

Inclusion Criteria

My organs are working well.

Your disease can be measured using a specific set of criteria called RECIST 1.1 by the study doctor in your area.

I am a man who will not have sex or will use birth control during and after the treatment.

+13 more

Exclusion Criteria

Known hypersensitivity or allergy to the active pharmaceutical ingredients or any component of the study intervention formulations

Your heart's electrical activity takes too long, more than 480 milliseconds.

I am currently being treated for an infection.

+18 more

Participant Groups

The study tests the effectiveness of combining Belzutifan with Lenvatinib against Cabozantinib alone in treating renal cell carcinoma. The main goal is to see if the combination leads to longer survival without cancer progression compared to Cabozantinib.

2Treatment groups

Experimental Treatment

Active Control

Group I: Belzutifan + LenvatinibExperimental Treatment2 Interventions

Belzutifan 120 mg and lenvatinib 20 mg orally once a day

Group II: CabozantinibActive Control1 Intervention

Cabozantinib 60 mg orally once a day

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