Belzutifan vs Everolimus for Renal Cell Carcinoma

Recruiting in Palo Alto (17 mi)

+172 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

Trial Summary

What is the purpose of this trial?The primary objective of this study is to compare belzutifan to everolimus with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and to compare everolimus with respect to overall survival (OS). The hypothesis is that belzutifan is superior to everolimus with respect to PFS and OS.

Eligibility Criteria

This trial is for adults with advanced renal cell carcinoma who've had no more than three prior treatments, are not pregnant or breastfeeding, and agree to use contraception. They must have progressed after treatment with specific cancer drugs (PD-1/L1 inhibitors and VEGF-TKIs) and have good organ function. Exclusions include other active cancers within 3 years, brain metastases, significant heart issues, allergies to the study drugs, recent major surgery or certain medications.

Inclusion Criteria

I am not pregnant or breastfeeding and, if able to have children, I agree to use contraception as advised.

My kidney cancer worsened after treatment with PD-1/L1 and VEGF-TKI.

My kidney cancer cannot be surgically removed and has spread.

+4 more

Exclusion Criteria

I cannot take pills by mouth or have a condition that affects how my body absorbs medication.

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

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

+19 more

Participant Groups

The study aims to see if Belzutifan improves survival without cancer progression compared to Everolimus in patients with advanced kidney cancer. It's a head-to-head comparison of these two drugs' effectiveness over time.

2Treatment groups

Experimental Treatment

Active Control

Group I: BelzutifanExperimental Treatment1 Intervention

Participants receive 120 mg of belzutifan orally once daily (QD)

Group II: EverolimusActive Control1 Intervention

Participants receive 10 mg of Everolimus orally once daily (QD)

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