~98 spots leftby May 2026

Immune and Targeted Combination Therapies for Kidney Cancer

Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Waitlist Available
Sponsor: Merck Sharp & Dohme LLC
No Placebo Group
Breakthrough Therapy

Trial Summary

What is the purpose of this trial?Substudy 03A is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03). The goal of substudy 03A is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced first line (1L) clear cell renal cell carcinoma (ccRCC). This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to demonstrate a tolerable safety profile for the combination of investigational agents. There will be no hypothesis testing in this study.

Eligibility Criteria

This trial is for adults with advanced first line clear cell renal cell carcinoma who haven't had systemic therapy for it. They must be able to take oral meds, have good organ function, and manage contraception if needed. Excluded are those with recent vaccines, multiple cancer treatments, immunodeficiency or other cancers within 3 years.

Inclusion Criteria

Side effects from my last treatment are mild or gone.
My kidney cancer has spread and is confirmed by tissue analysis.

Exclusion Criteria

I have received an organ or tissue transplant from another person.
I have nutrient absorption issues due to past stomach or intestine surgery or disease.
I have high protein in my urine and either low oxygen levels, need oxygen support, or had recent severe coughing with blood.
I have a history of lung disease.
I have a preexisting abnormal connection between two parts inside my body.
I have undergone more than 4 cancer treatment plans.
I have a history of Hepatitis B.
I am currently being treated for an infection.
I have an autoimmune disease but haven't needed systemic treatment in the last 2 years.
I have a history of inflammatory bowel disease.
I have another cancer that is getting worse or was treated in the last 3 years.
I have not had major surgery in the last 3 weeks.
I have cancer that has spread to my brain or spinal cord.

Treatment Details

The study tests combinations of experimental drugs like Pembrolizumab and others (Favezelimab/Pembrolizumab, Belzutifan) in two phases: a safety phase to ensure tolerability and an efficacy phase without hypothesis testing.
5Treatment groups
Experimental Treatment
Group I: Pembrolizumab + LenvatinibExperimental Treatment2 Interventions
Participants will receive pembrolizumab 400 mg PLUS lenvatinib 20 mg. Pembrolizumab will be administered IV Q6W for up to 17 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 IV Q6W for up to 17 administrations (up to \~2 years). Both belzutifan and lenvatinib will be administered orally QD until progressive disease or discontinuation.
Group III: Coformulation Vibostolimab/Pembrolizumab+BelzutifanExperimental Treatment2 Interventions
Participants will receive vibostolimab/pembrolizumab (coformulation of 200 mg vibostolimab and pembrolizumab 200 mg). Vibostolimab/pembrolizumab will be administered IV once every 3 weeks (Q3W) for up to 35 administrations (up to \~2 years). Belzutifan will be administered orally QD until progressive disease or discontinuation.
Group IV: Coformulation Pembrolizumab/Quavonlimab + LenvatinibExperimental Treatment2 Interventions
Participants will receive pembrolizumab/quavonlimab (coformulation of pembrolizumab 400 mg and quavonlimab 25 mg) PLUS lenvatinib 20 mg. Pembrolizumab/quavonlimab will be administered intravenously (IV) once every 6 weeks (Q6W) for up to 17 administrations (up to \~2 years). Lenvatinib will be administered orally once-daily (QD) until progressive disease or discontinuation.
Group V: Coformulation Favezelimab/Pembrolizumab+ LenvatinibExperimental Treatment2 Interventions
Participants will receive favezelimab/pembrolizumab (coformulation of favezelimab 800 mg and pembrolizumab 200 mg) PLUS lenvatinib 20 mg. Favezelimab/Pembrolizumab will be administered IV once every 3 weeks (Q3W) for up to 35 administrations (up to \~2 years). Lenvatinib will be administered orally QD until progressive disease or discontinuation.
Belzutifan is already approved in United States for the following indications:
🇺🇸 Approved in United States as Welireg for:
  • Advanced renal cell carcinoma (RCC) following a PD-1 or PD-L1 inhibitor and a VEGF TKI
  • Von Hippel-Lindau disease-associated RCC, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors

Find a clinic near you

Research locations nearbySelect from list below to view details:
Yale-New Haven Hospital-Yale Cancer Center ( Site 1011)New Haven, CT
Henry Ford Health System ( Site 1014)Detroit, MI
University of California at San Francisco ( Site 1008)San Francisco, CA
University of Chicago ( Site 1013)Chicago, IL
More Trial Locations
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Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
Merck Sharp & Dohme Corp.Lead Sponsor

References