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Immune and Targeted Combination Therapies for Kidney Cancer

Phase 1 & 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~43 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Efficacy Phase: Clinical benefit rate (CBR)
Efficacy Phase: Duration of response (DOR)
Efficacy Phase: Overall survival (OS)
+1 more

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 2
~2010
Favezelimab/Pembrolizumab
2016
Completed Phase 1
~490
Belzutifan
2018
Completed Phase 1
~40
Lenvatinib
2005
Completed Phase 4
~2690
Pembrolizumab/Quavonlimab
2017
Completed Phase 2
~420

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,887 Previous Clinical Trials
5,054,294 Total Patients Enrolled
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,503 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,124 Total Patients Enrolled

Media Library

Belzutifan (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04626479 — Phase 1 & 2
Renal Cell Carcinoma Research Study Groups: Coformulation Favezelimab/Pembrolizumab+ Lenvatinib, Pembrolizumab + Lenvatinib, Pembrolizumab + Belzutifan + Lenvatinib, Coformulation Vibostolimab/Pembrolizumab+Belzutifan, Coformulation Pembrolizumab/Quavonlimab + Lenvatinib
Renal Cell Carcinoma Clinical Trial 2023: Belzutifan Highlights & Side Effects. Trial Name: NCT04626479 — Phase 1 & 2
Belzutifan (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04626479 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what capacity is Pembrolizumab typically prescribed?

"Pembrolizumab is a commonly used treatment for unresectable melanoma, but it can also be taken to help patients with microsatellite instability high and those at risk of recurrent disease."

Answered by AI

What precedent has been set by prior research with Pembrolizumab?

"Pembrolizumab was first investigated at City of Hope in 2010, and since then 303 trials have been concluded. Currently 1042 clinical studies are active, with a considerable number originating from Iowa City, Iowa."

Answered by AI

What objectives is this experiment attempting to accomplish?

"Merck Sharp & Dohme LLC, the trial's sponsor, has determined that its primary outcome will be assessed over a period of around 21 days. It involves tracking adverse events among participants in the study population. Additionally, secondary outcomes such as duration of response (defined by RECIST 1.1), overall survival rate and Clinical Benefit Rate (CBR) are being evaluated during this clinical trial too."

Answered by AI

For whom is this research opportunity available?

"This trial is seeking a total of 400 individuals with carcinoma, renal cell that are aged between 18 and 120 years. Necessary entry criteria includes: no prior systemic therapy for advanced RCC; able to consume oral medication; sufficient organ functions; non-pregnant females abstaining from heterosexual intercourse or using contraception during the study intervention period and at least 120 days after the last dose of pembrolizumab, etc.; histologically confirmed diagnosis of locally advanced/metastatic ccRCC; resolution of toxic effects ≤Grade 1; male participants must abide by certain contraceptive regulations depending on which drugs they receive (lenv"

Answered by AI

Is there still space available for participants in this research endeavor?

"Indeed, the clinical trial is actively recruiting. According to information hosted on clinicaltrials.gov, it was first posted on December 16th 2020 and updated November 18th 2022. 400 individuals are needed for participation between 11 different medical sites."

Answered by AI

Are individuals younger than 45 years of age admissible to this medical study?

"Patients aged 18-120 are eligible for this trial, as specified by its inclusion criteria. Furthermore, there are 116 trials available to those underage and 3590 studies specifically targeting the elderly population."

Answered by AI

What is the aggregate amount of individuals enrolled in this trial?

"This clinical trial necessitates the enrolment of 400 qualified individuals. Patients may sign up through University of Iowa (Site 1012) in Iowa City, IA and Duke Cancer Institute (Site 1015) in Durham, NC."

Answered by AI

How many healthcare facilities are currently conducting this research?

"11 medical centres have been identified as possible recruitment sites, including University of Iowa (Site 1012) in Iowa City, Duke Cancer Institute ( Site 1015) in Durham and Jewish General Hospital ( Site 1100) in Montreal."

Answered by AI
~154 spots leftby May 2026