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Small Molecule

Drug Combinations 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

Has histologically confirmed diagnosis of RCC with clear cell component

Has received no prior systemic therapy for advanced ccRCC

Must not have

Has a history of noninfectious pneumonitis that required steroids or has current pneumonitis

Has a known history of Hepatitis B

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 66 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing whether two different combinations of drugs are better than another combination of drugs at treating kidney cancer.

Who is the study for?

This trial is for adults with advanced clear cell renal cell carcinoma who haven't had systemic therapy for it. They must have good organ function, controlled blood pressure, and agree to contraception if applicable. Exclusions include other active cancers within 3 years, recent major surgery or radiotherapy, certain heart diseases, lung conditions like interstitial disease or pneumonitis, uncontrolled infections including HIV or Hepatitis B.

What is being tested?

The study tests the effectiveness of pembrolizumab combined with belzutifan and lenvatinib or a combo of pembrolizumab/quavonlimab with lenvatinib against just pembrolizumab plus lenvatinib in treating kidney cancer. It aims to see which combination leads to longer survival without disease progression.

What are the potential side effects?

Potential side effects may include immune-related reactions affecting organs, high blood pressure from lenvatinib use, fatigue, liver issues from pembrolizumab and quavonlimab; as well as risks associated with taking multiple medications at once.

Eligibility Criteria

Inclusion Criteria

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

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My kidney cancer has been confirmed to have a clear cell component.

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I have not had any treatment for advanced kidney cancer.

Exclusion Criteria

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

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I have had or currently have lung inflammation treated with steroids.

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I have a history of Hepatitis B.

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I have a preexisting abnormal connection between two body parts.

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My cancer is affecting a major blood vessel.

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My cancer has spread to my brain or spinal cord.

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I am currently being treated for an infection.

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I have had a serious heart condition in the last year.

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I have a history of lung scarring or fibrosis.

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I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.

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I have another cancer that is getting worse or was treated in the last 3 years.

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I had radiotherapy less than 2 weeks before starting the study treatment.

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I have received an organ or tissue transplant from another person.

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I have not received a live vaccine within the last 30 days.

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I have an autoimmune disease treated with medication in the last 2 years.

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I have had significant bleeding issues in the last 3 months.

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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 66 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 66 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 66 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) According to 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 RECIST 1.1 as Assessed by BICR

Number of Participants Who Discontinue Study Treatment Due to an AE

Number of Participants Who Experienced At least One Adverse Event (AE)

+1 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Pembrolizumab/Quavonlimab + LenvatinibExperimental Treatment2 Interventions

Participants will receive pembrolizumab/quavonlimab (co-formulation of pembrolizumab 400 mg and quavonlimab 25 mg) PLUS lenvatinib 20 mg. Pembrolizumab/quavonlimab will be administered IV Q6W for up to 18 administrations (up to \~2 years). Lenvatinib will be administered orally QD until progressive disease or discontinuation.

Group II: Pembrolizumab + Belzutifan + LenvatinibExperimental Treatment3 Interventions

Participants will receive pembrolizumab 400 mg PLUS belzutifan 120 mg PLUS lenvatinib 20 mg. Pembrolizumab will be administered intravenously (IV) once every 6 weeks (Q6W) for up to 18 administrations (up to \~2 years). Belzutifan and lenvatinib will be administered orally once daily (QD) until progressive disease or discontinuation.

Group III: Pembrolizumab + LenvatinibActive Control2 Interventions

Participants will receive pembrolizumab 400 mg PLUS lenvatinib 20 mg. Pembrolizumab will be administered IV Q6W for up to 18 administrations (up to \~2 years). Lenvatinib will be administered orally QD until progressive disease or discontinuation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Belzutifan

2018

Completed Phase 1

~50

Pembrolizumab/Quavonlimab

2017

Completed Phase 2

~420