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Trials
Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B/KEYMAKER-U03)

trialsTrialActive

Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B/KEYMAKER-U03)

A phase 1/2 trial of Pembrolizumab, Belzutifan, Lenvatinib and Favezelimab in renal cell carcinoma, run by Merck Sharp & Dohme LLC, active and no longer recruiting.

Also called: KEYMAKER-U03

Overview Connected6

Overview

Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B/KEYMAKER-U03) is a phase 1/2 interventional study registered as NCT04626518 by Merck Sharp & Dohme LLC, with 370 participants enrolled, started 2020-12-17 and due to reach its primary completion in 2026-08-21. Interventions recorded: Pembrolizumab, MK-4830, Belzutifan, Lenvatinib, Pembrolizumab/Quavonlimab and Favezelimab/Pembrolizumab.

Setting

A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (KEYMAKER-U03): Substudy 03B in Second-Line Metastatic Participants

Phase

Phase 1/2

Sponsor

Merck Sharp & Dohme LLC

Registry

Started

2020-12-17

Enrolled

370 enrolled

Connected

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cancers

Renal cell carcinoma

drugs

ApprovedSmall-molecule HIF-2α inhibitor

Belzutifan · Welireg

Phase 3Anti-LAG-3 monoclonal antibody, intravenous, also coformulated with pembrolizumab (MK-4280A)

ApprovedSmall-molecule multi-kinase inhibitor (VEGFR, FGFR, PDGFR, RET, KIT)

Lenvatinib · Lenvima

ApprovedMonoclonal antibody (anti-PD-1)

Pembrolizumab · Keytruda / Keytruda Qlex (SC)

companies

Merck & Co. (MSD)

Evidence strength26/100 · Preliminary

How much and what kind of evidence, not how big the benefit. Click for the breakdown.

Phase 1/2+8
370 enrolled+13
No structured primary endpoint0
Result: active0
No independent replication recorded0
A linked product is approved+5

Formula disclosed on the evidence page.

ProvenanceLast edited 2026-09-18 · Jude Gomila · Trial acronyms for registry records · diff · file

Sources & links

ClinicalTrials.gov NCT04626518

Data

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Cancers

Renal cell carcinoma

Products

Pembrolizumab
Belzutifan
Lenvatinib
Favezelimab

Companies

Merck & Co. (MSD)

Not yet reviewedNeeds expert (clinical) review. Review this page or see the review queue and roster.

Model panel commentary is coming to this page: machine commentary, not clinical review.

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