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HIF-2alpha Inhibitor

Belzutifan for Kidney Cancer

Phase 2

Waitlist Available

Research Sponsored by Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has at least 1 measurable solid RCC tumor and no RCC tumor that requires immediate surgical intervention. The diagnosis of RCC can be radiologic (histologic diagnosis not required). Participants may have VHL disease-associated tumors in other organ systems

Has a diagnosis of von Hippel Lindau disease, based on a germline VHL alteration

Must not have

Has evidence of metastatic disease on screening imaging

Has received prior treatment with belzutifan or another HIF-2α inhibitor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if belzutifan can shrink tumors in people with von Hippel-Lindau disease-related kidney cancer.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

While specific side effects of belzutifan in this trial are not listed here, common side effects may include fatigue, nausea, anemia (low red blood cell count), and hypoxia (low oxygen levels).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have been diagnosed with von Hippel Lindau disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have received treatments targeting cancer growth.

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I need surgery soon for my cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR) in VHL Disease-Associated RCC Tumors

Secondary study objectives

Belzutifan Metabolite Plasma Concentration

Belzutifan Plasma Concentration

DOR in VHL Disease-Associated Non-RCC Tumors

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Belzutifan

2018

Completed Phase 1

~50

0 / 6Eligibility criteria met