← Back to Search

Other

Immune + Targeted Therapies for Renal Cell Carcinoma

Phase 1 & 2

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 experienced disease progression on or after having received systemic treatment for locally advanced or metastatic RCC with a PD-(L)1 checkpoint inhibitor or VEGF-TKI

Has a histologically confirmed diagnosis of locally advanced/metastatic ccRCC

Must not have

Has received prior treatment with belzutifan

Has preexisting gastrointestinal (GI) or non-GI fistula

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~56 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is a substudy of a larger study that is testing experimental treatments for renal cell carcinoma. The goal of this substudy is to see if the combination of investigational agents is safe and effective in people with advanced ccRCC.

Who is the study for?

This trial is for adults with advanced renal cell carcinoma who've seen their cancer progress after treatment with specific systemic therapies. They must be able to take oral meds, have good organ function, controlled blood pressure, and no recent major surgery or active infections. Women of childbearing potential must use contraception and not be pregnant or breastfeeding.

What is being tested?

The study tests combinations of experimental drugs (MK-4830, Pembrolizumab/Quavonlimab, Favezelimab/Pembrolizumab) in two phases: first ensuring safety (no severe reactions), then checking if they work against kidney cancer that's worsened despite previous treatments.

What are the potential side effects?

Potential side effects include immune system reactions possibly affecting organs, high blood pressure from Lenvatinib/Belzutifan combo which also requires birth control due to risks in pregnancy. Other effects may vary based on the drug combination received.

Eligibility Criteria

Inclusion Criteria

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

Select...

My kidney cancer worsened after treatment with specific immune or targeted therapies.

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 been treated with belzutifan before.

Select...

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

Select...

I have an immune system disorder or have been on immune-weakening medication recently.

Select...

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

Select...

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

Select...

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

Select...

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

Select...

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

Select...

I have a history of Hepatitis B.

Select...

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

Select...

I have been treated with pembrolizumab and lenvatinib together.

Select...

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

Select...

I have undergone more than 4 cancer treatment plans.

Select...

I have a history of inflammatory bowel disease.

Select...

I am currently being treated for an infection with medication.

Select...

My cancer has spread to my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~56 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to ~56 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~56 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 experienced 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

6Treatment groups

Experimental Treatment

Group I: Pembrolizumab + MK-4830Experimental Treatment2 Interventions

Participants will receive pembrolizumab 200 mg PLUS MK-4830 800 mg. Both pembrolizumab and MK-4830 will be administered IV Q3W for up to 35 administrations (up to \~2 years).

Group II: 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 III: Pembrolizumab + BelzutifanExperimental Treatment2 Interventions

Participants will receive pembrolizumab 400 mg PLUS belzutifan 120 mg. Pembrolizumab will be administered IV Q6W for up to 17 administrations (up to \~ 2 years). Belzutifan will be administered orally once-daily (QD) until progressive disease or discontinuation.

Group IV: Coformulation Pembrolizumab/QuavonlimabExperimental Treatment1 Intervention

Participants will receive pembrolizumab/quavonlimab (coformulation of pembrolizumab 400 mg and quavonlimab 25 mg). Pembrolizumab/quavonlimab will be administered intravenously (IV) once every 6 weeks (Q6W) for up to 17 administrations (up to \~2 years).

Group V: Coformulation Favezelimab/PembrolizumabExperimental Treatment1 Intervention

Participants will receive favezelimab/pembrolizumab (coformulation of favezelimab 800 mg and pembrolizumab 200 mg). Favezelimab/Pembrolizumab will be administered IV once every 3 weeks (Q3W) for up to 35 administrations (up to \~2 years).

Group VI: Belzutifan + LenvatinibExperimental Treatment2 Interventions

Participants will receive Belzutifan 120 mg PLUS lenvatinib 20 mg. Both belzutifan and lenvatinib will be administered orally QD until progressive disease or discontinuation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MK-4830

2022

Completed Phase 2

~160

Pembrolizumab

2017

Completed Phase 3

~3150