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Trials
Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A)

trialsTrialActive

Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A)

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

Overview Connected6

Overview

Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A) is a phase 1/2 interventional study registered as NCT04626479 by Merck Sharp & Dohme LLC, with 400 participants enrolled, started 2020-12-16 and due to reach its primary completion in 2026-08-21. Interventions recorded: Pembrolizumab, Favezelimab/Pembrolizumab, Belzutifan, Lenvatinib, Pembrolizumab/Quavonlimab and Vibostolimab/Pembrolizumab.

Setting

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

Phase

Phase 1/2

Sponsor

Merck Sharp & Dohme LLC

Registry

Started

2020-12-16

Enrolled

400 enrolled

Connected

Similar pages

Trial
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)
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Safety and Efficacy Study of Investigational Agents as Monotherapy or in Combination With Pembrolizumab (MK-3475) for the Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Need of Second-Line Therapy (MK-3475-B98/KEYNOTE-B98)
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Shares Belzutifan, Lenvatinib, Merck & Co. (MSD), Renal cell carcinoma and the tag pipeline.
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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
400 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 2026-09-16 · Jude Gomila · Registry trials wave 6 and products wave 7 · diff · file

Sources & links

ClinicalTrials.gov NCT04626479

Data

JSON ·

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Cancers

Renal cell carcinoma

Products

Pembrolizumab
Favezelimab
Belzutifan
Lenvatinib

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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