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KEYMAKER-U04 Substudy 04D: A Clinical Study of New Treatments Given With Enfortumab Vedotin and Pembrolizumab in People With Urothelial Cancer (MK-3475-04D/KEYMAKER-U04)

NCT07232602 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2026-04-24

No results posted yet for this study

Summary

Researchers are looking for new ways to treat people with urothelial cancer (UC) that is locally advanced or metastatic. The standard treatment for locally advanced or metastatic UC is enfortumab vedotin (EV) given with pembrolizumab.

The goals of this study are to learn about:

* The safety of the study treatment when given with standard treatment and if people tolerate it
* The number of people who have the cancer respond (cancer gets smaller or goes away) with the new study treatment when given with standard treatment.

Conditions

Interventions

DRUG

MK-3120

Administered via intravenous (IV) infusion on day 1 and day 8 of each 3-week cycle

DRUG

EV

Administered via IV infusion on day 1 and day 8 of each 3-week cycle

BIOLOGICAL

Pembrolizumab

Administered via IV infusion on day 1 of each 3-week cycle

DRUG

Rescue Medication

Participants receive rescue medication at the investigator's discretion, per approved product label. Recommended rescue medication is Granulocyte Colony-Stimulating Factor (G-CSF).

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-09
Primary Completion
2031-07-08
Completion
2031-07-08
FDA Drug
Yes

Countries

  • United States
  • Chile
  • France
  • Israel
  • Netherlands
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07232602 on ClinicalTrials.gov