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HIF-2alpha Inhibitor

Belzutifan + Lenvatinib vs. Cabozantinib for Kidney Cancer

Phase 3

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

Unresectable, locally advanced or metastatic clear cell renal cell carcinoma (RCC)

Adequately controlled blood pressure

Must not have

Active infection requiring systemic therapy

History of significant bleeding within 3 months before randomization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 44 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare the effectiveness of two different drugs for people with a specific type of kidney cancer.

Who is the study for?

This trial is for adults with advanced renal cell carcinoma who have seen their cancer progress after anti-PD-1/L1 therapy. They should have measurable disease, a Karnofsky performance status of at least 70%, and no more than two prior systemic treatments. Participants must not be pregnant or breastfeeding and agree to use contraception.

What is being tested?

The study tests the effectiveness of combining Belzutifan with Lenvatinib against Cabozantinib alone in treating renal cell carcinoma. The main goal is to see if the combination leads to longer survival without cancer progression compared to Cabozantinib.

What are the potential side effects?

Potential side effects include high blood pressure, fatigue, nausea, diarrhea, decreased appetite, weight loss, vomiting, constipation, and joint/muscle pain. There may also be risks related to liver function changes and protein levels in urine.

Eligibility Criteria

Inclusion Criteria

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

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My kidney cancer cannot be surgically removed and has spread.

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My blood pressure is under control.

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I have had 2 or fewer previous treatments for my condition.

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My kidney cancer worsened after PD-1/L1 therapy.

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My kidney cancer cannot be removed by surgery and has spread.

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I am mostly independent and can care for myself.

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I am mostly able to care for myself but may not be able to do active work.

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I have had one prior treatment with antiPD-1/L1 for kidney cancer.

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My kidney cancer worsened after PD-1/L1 therapy.

Exclusion Criteria

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

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I am currently being treated for an infection.

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I have not had significant bleeding in the last 3 months.

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I have had a solid organ transplant.

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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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I have been treated with cabozantinib before.

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I have a severe fistula.

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I have been treated with lenvatinib before.

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I have a history of HIV infection.

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My liver is not working well.

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I have had hepatitis B or currently have hepatitis C.

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My cancer has spread to my brain or spinal cord.

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I have fluid in my chest causing symptoms like coughing or trouble breathing.

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

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I need extra oxygen sometimes or all the time.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 44 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 44 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 44 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

Overall Survival (OS)

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)

Secondary study objectives

Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)

Number of Participants Who Experienced One or More Adverse Events (AEs)

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