Belzutifan vs Everolimus for Renal Cell Carcinoma
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, specifically strong or moderate inhibitors and inducers of CYP3A4, for the duration of the study. If you are on these medications, you will need to discuss with your doctor about discontinuing them before participating.
What data supports the effectiveness of the drug Everolimus for treating renal cell carcinoma?
Everolimus has been shown to increase progression-free survival in patients with advanced renal cell carcinoma, particularly after other treatments like sunitinib and sorafenib have failed. In clinical trials, patients taking Everolimus had a median progression-free survival of 4.9 months compared to 1.9 months for those on a placebo.12345
What is the safety profile of Everolimus for renal cell carcinoma?
What makes the drugs Belzutifan and Everolimus unique for treating renal cell carcinoma?
Belzutifan and Everolimus are unique because they target specific pathways involved in cancer growth. Everolimus is an mTOR inhibitor, which helps slow down cancer cell growth, while Belzutifan is a newer drug that targets a different pathway, potentially offering a novel approach for patients who have not responded to other treatments.13457
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.
Research Team
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Safety Run-In
Non-randomized participants received up to 120 mg of belzutifan QD
Treatment
Randomized participants received either 120 mg of belzutifan or 10 mg of everolimus orally once daily until disease progression or discontinuation
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Belzutifan
- Everolimus
Belzutifan is already approved in United States for the following indications:
- 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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme Corp.
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme Corp.
Chief Medical Officer
Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme Corp.
Chief Executive Officer since 2021
J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Merck Sharp & Dohme LLC
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University