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)

Part of paid clinical trials in San Francisco, California.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07232602
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MK-3120 — DRUG
    Administered via intravenous (IV) infusion on day 1 and day 8 of each 3-week cycle
  • EV — DRUG
    Administered via IV infusion on day 1 and day 8 of each 3-week cycle
  • Pembrolizumab — BIOLOGICAL
    Administered via IV infusion on day 1 of each 3-week cycle
  • Rescue Medication — DRUG
    Participants receive rescue medication at the investigator's discretion, per approved product label. Recommended rescue medication is Granulocyte Colony-Stimulating Factor (G-CSF).

Study Details

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.

Key Dates

Start date
Feb 9, 2026
Status verified
Apr 2026
Primary completion
Jul 8, 2031
Completion
Jul 8, 2031

Study Design

Enrollment
55 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: MK-3120 + Enfortumab Vedotin (EV) + Pembrolizumab
    Participants will receive MK-3120 administered intravenously on Day 1 and Day 8 of each 3-week cycle and EV administered intravenously on Day 1 and Day 8 of each 3-week cycle until documented disease progression or any other discontinuation criterion is met and Pembrolizumab 200 mg administered intravenously on Day 1 of each 3-week cycle for up to 35 cycles (\~2 years).

Primary Outcome Measure

Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 27 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
UCSF Medical Center at Mission Bay ( Site 5044)San FranciscoCalifornia94158
Study Coordinator
415-699-7286
Cleveland Clinic Taussig Cancer ( Site 5036)ClevelandOhio44195
Study Coordinator
216-444-8311
Huntsman Cancer Institute ( Site 5041)Salt Lake CityUtah84112-5550
Study Coordinator
801-585-0155

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