← Back to Search

Other

Immune and Targeted Combination Therapies for Kidney Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

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

Must have

Has resolution of toxic effects of the most recent prior therapy to ≤Grade 1

Has a histologically confirmed diagnosis of locally advanced/metastatic ccRCC

Must not have

Has had an allogenic tissue/solid organ transplant

Has malabsorption due to prior GI surgery or disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~43 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying new combinations of drugs to treat renal cell carcinoma. The goal is to find new ways to treat this disease that are more effective and have fewer side effects than current treatments.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include immune reactions due to the investigational nature of the drugs being tested. Specifics will vary based on each drug combination but can range from mild symptoms like fatigue to more serious conditions affecting organ function.

Eligibility Criteria

Inclusion Criteria

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

Select...

Side effects from my last treatment are mild or gone.

Select...

My kidney cancer has spread and is confirmed by tissue analysis.

Exclusion Criteria

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

Select...

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

Select...

I have nutrient absorption issues due to past stomach or intestine surgery or disease.

Select...

I have high protein in my urine and either low oxygen levels, need oxygen support, or had recent severe coughing with blood.

Select...

I have a history of lung disease.

Select...

I have a preexisting abnormal connection between two parts inside my body.

Select...

I have undergone more than 4 cancer treatment plans.

Select...

I have a history of Hepatitis B.

Select...

I am currently being treated for an infection.

Select...

I have an autoimmune disease but haven't needed systemic treatment in the last 2 years.

Select...

I have a history of inflammatory bowel disease.

Select...

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

Select...

I have not had major surgery in the last 3 weeks.

Select...

I have cancer that has spread to my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~43 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to ~43 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~43 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

Efficacy Phase: Number of participants who discontinue study treatment due to an AE

Efficacy Phase: Number of participants who experience one or more AEs

Efficacy Phase: Number of participants who experience one or more DLTs

+4 more

Secondary study objectives

Efficacy Phase: Clinical benefit rate (CBR)

Efficacy Phase: Duration of response (DOR)

Efficacy Phase: Overall survival (OS)

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~2810

Favezelimab/Pembrolizumab

2016

Completed Phase 1

~490