Trial intelligence / Profile preview

KEYMAKER-U04 Substudy 04D: Investigational Agents With Enfortumab Vedotin Plus Pembrolizumab in First-Line Urothelial Carcinoma

2025-522253-19-00Phase 2Authorised

Sponsor
Merck & Co.
Start
Feb 2026
Modality
Immune Checkpoint Inhibitors → Monoclonal Antibodies → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes, Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics
Countries
8
01

Overview

Phase 2, open-label trial of pembrolizumab, enfortumab vedotin and MK-3120 in transitional cell carcinoma (TCC) (2 arms), sponsored by Merck & Co. Primary endpoints: Number of Participants Who Experienced At Least One Adverse Event, Number of Participants with Dose-limiting Toxicities and 2 more. Planned start Feb 2026; status: authorised.

02

Drugs

pembrolizumabenfortumab vedotinMK-3120
03

Conditions

transitional cell carcinoma (TCC)

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