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HIF-2 Alpha Inhibitor

Belzutifan for Kidney Cancer

Phase 2

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

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

Must have

Has received no more than 3 prior systemic regimens for locally advanced or metastatic RCC

Has a Karnofsky performance status (KPS) score of at least 70% assessed within 10 days prior to the first dose of study intervention

Must not have

Has received prior treatment with belzutifan or another hypoxia-inducible factor (HIF)-2α inhibitor

Has moderate to severe hepatic impairment (Child-Pugh B or C)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 27 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effectiveness of two doses of belzutifan in people with advanced kidney cancer that has spread after previous treatment. The higher dose is expected to be better in terms of tumor shrinkage.

Who is the study for?

This trial is for adults with advanced renal cell carcinoma who have previously been treated with anti-PD-1/L1 therapy. They must be in good physical condition (KPS score ≥70%), able to use contraception, and not pregnant or breastfeeding. Participants should have no more than three prior treatments for RCC, only one of which can be anti-PD-1/L1 therapy.

What is being tested?

The study tests two different doses of belzutifan to see which one works better for treating advanced renal cell carcinoma after previous therapies. The main goal is to compare the objective response rates between the standard dose and a higher dose.

What are the potential side effects?

Potential side effects of belzutifan may include fatigue, nausea, anemia (low red blood cells), hypoxia (low oxygen levels), and issues affecting liver function. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

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

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I have had 3 or fewer treatments for advanced kidney cancer.

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I am mostly able to care for myself and am up more than 50% of my waking hours.

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My kidney cancer has spread and shows clear cell features.

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I have had one prior treatment with anti-PD-1/L1 for advanced kidney cancer.

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My kidney cancer worsened after treatment with specific immune therapies.

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I can provide a sample of my tumor that hasn't been treated with radiation.

Exclusion Criteria

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

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

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My liver is not working well (moderate to severe issues).

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I need extra oxygen sometimes or all the time.

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I am taking medication that strongly or moderately affects liver enzymes and cannot stop during the study.

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

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My cancer has spread to my brain or its coverings.

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I have active tuberculosis.

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I have serious heart problems, such as recent heart attacks or severe heart failure.

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I had radiotherapy less than 2 weeks ago and have recovered from side effects without needing steroids.

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I have been diagnosed with an immune system disorder.

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I have not taken any kinase inhibitor medication in the last 2 weeks.

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I have a history of hepatitis B or active hepatitis C.

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I have another cancer besides skin cancer that hasn't needed treatment in the last 3 years.

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I am currently being treated for an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 27 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 27 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 27 months 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) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

Secondary study objectives

Clinical Benefit Rate (CBR) Per RECIST 1.1 as Assessed by BICR

Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR

Maximum Plasma Concentration (Cmax) of Belzutifan

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