A Phase 1/2 Randomized, Umbrella Study to Evaluate the Efficacy and Safety of MK-2870 Plus Enfortumab Vedotin (EV) With and Without Pembrolizumab, as Treatment for Participants With Advanced Urothelial Carcinoma (KEYMAKER-U04): Substudy 04C

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506387-14-00

Acronym

MK-3475-04C

Enrollment

Registered

2024-09-03

Start date

2024-09-24

Completion date

Unknown

Last updated

2025-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Urothelial Carcinoma

Brief summary

Part 1: AEs, DLT, Discontinuation of study intervention due to an AE, Part 2: AEs, DLT, Discontinuation of study intervention due to an AE, Part 2: OR: CR or PR

Detailed description

Part 1: OR: CR or PR, Part 2: DOR: For participants who demonstrate confirmed CR or PR, the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first., Part 1: PK exposures including Cmax and Ctrough of ADC and free payload for MK-2870 and EV, Part 1: ADA formation to MK-2870 and EV, Part 2: PK exposures including Cmax and Ctrough of ADC and free payload for MK-2870 and EV, and of pembrolizumab, Part 2: ADA formation to MK-2870, pembrolizumab, and EV

Interventions

DRUG-

DRUGPARACETAMOL

DRUGENFORTUMAB VEDOTIN

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGMK-2870

DRUGDEXAMETHASONE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Part 1: AEs, DLT, Discontinuation of study intervention due to an AE, Part 2: AEs, DLT, Discontinuation of study intervention due to an AE, Part 2: OR: CR or PR	—

Secondary

Measure	Time frame
Part 1: OR: CR or PR, Part 2: DOR: For participants who demonstrate confirmed CR or PR, the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first., Part 1: PK exposures including Cmax and Ctrough of ADC and free payload for MK-2870 and EV, Part 1: ADA formation to MK-2870 and EV, Part 2: PK exposures including Cmax and Ctrough of ADC and free payload for MK-2870 and EV, and of pembrolizumab, Part 2: ADA formation to MK-2870, pembrolizumab, and EV	—

Measure

Time frame

—

Countries

Denmark, France, Italy, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026