Belzutifan for Kidney Cancer

Recruiting in Palo Alto (17 mi)

+10 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This study is designed to investigate belzutifan as a treatment for VHL disease associated RCC.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for individuals with von Hippel Lindau disease who have at least one measurable kidney cancer tumor but don't need immediate surgery. They shouldn't have used belzutifan or similar drugs before, had any cancer treatments like anti-VEGF therapy, require urgent tumor surgery, or have metastatic disease.

Inclusion Criteria

I have a measurable kidney cancer tumor that doesn't need immediate surgery.

I have been diagnosed with von Hippel Lindau disease.

Exclusion Criteria

My scans show cancer has spread to other parts of my body.

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

I have received treatments targeting cancer growth.

See 1 more

Treatment Details

Interventions

Belzutifan (HIF-2alpha Inhibitor)

Trial OverviewThe study tests belzutifan as a potential treatment for kidney cancer associated with von Hippel Lindau disease. It aims to understand the effectiveness and safety of this medication in patients diagnosed with VHL-related renal cell carcinoma.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Open Label BelzutifanExperimental Treatment1 Intervention

Participants receive 120 mg belzutifan orally once daily. Participants may continue to receive belzutifan in the absence of unacceptable treatment related toxicity or unequivocal disease progression.

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