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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 66 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My kidney cancer has been confirmed to have a clear cell component.
Select...
I have not had any treatment for advanced kidney cancer.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreTrial 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
Lenvatinib
2005
Completed Phase 4
~2690
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,580,344 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,906 Previous Clinical Trials
5,063,165 Total Patients Enrolled
Eisai Inc.Industry Sponsor
516 Previous Clinical Trials
157,380 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I started treatment for bone loss at least 2 weeks before joining the study.I have had or currently have lung inflammation treated with steroids.I have a history of Hepatitis B.I have not had major surgery within the last 4 weeks, except for kidney removal.I have a preexisting abnormal connection between two body parts.My cancer is affecting a major blood vessel.My cancer has spread to my brain or spinal cord.I am currently being treated for an infection.I have had a serious heart condition in the last year.I have a history of lung scarring or fibrosis.My blood pressure is under control, with or without medication.My organs are functioning well.I am a male who will not have sex or will use birth control during and for 7 days after my last dose of the study drugs.I had fluid in my chest but am stable after treatment.I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.I am not pregnant or breastfeeding, and if I can have children, I use effective birth control or practice abstinence.I have another cancer that is getting worse or was treated in the last 3 years.I had radiotherapy less than 2 weeks before starting the study treatment.I have received an organ or tissue transplant from another person.I have not received a live vaccine within the last 30 days.I have an autoimmune disease treated with medication in the last 2 years.You have been diagnosed with HIV.I have had significant bleeding issues in the last 3 months.I need extra oxygen sometimes or all the time.My kidney cancer has been confirmed to have a clear cell component.I have not had any treatment for advanced kidney cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab/Quavonlimab + Lenvatinib
- Group 2: Pembrolizumab + Lenvatinib
- Group 3: Pembrolizumab + Belzutifan + Lenvatinib
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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