Recruiting
Phase 1
Phase 2

Enfortumab Vedotin & Pembrolizumab

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07232602

Conditions

Bladder Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MK-3120

EV

Pembrolizumab

Rescue Medication

Study Details

Brief 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

Bladder Cancer

Study ID

NCT07232602

Start date

Feb 9, 2026

Status verified date

Aug, 2026

Completion date

Jul 8, 2031

Anticipated

Primary completion date

Jul 8, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • Has histologically documented urothelial carcinoma (UC) that is locally advanced and unresectable or metastatic
  • Must provide a newly obtained or archival tumor tissue sample (core or excisional biopsy)
  • Must not have received prior systemic therapy for locally advanced or metastatic UC
  • If infected with Human Immunodeficiency Virus (HIV), has well controlled HIV on antiretroviral therapy
  • If positive for hepatitis B surface antigen, has received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and has undetectable HBV viral load before randomization
  • If participant has a history of hepatitis C virus (HCV), has undetectable HCV viral load before randomization

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing
  • Has active keratitis or corneal ulcerations
  • Has active inflammatory bowel disease requiring immunosuppressive medication, or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention
  • Has a history of uncontrolled diabetes
  • Has pleural effusion, ascites, and/or pericardial effusion that are symptomatic or require repeated drainage
  • Has active autoimmune disease that has required systemic treatment in the past 2 years
  • Has known additional malignancy that is progressing or has required active treatment within the past 2 years
  • Has known active central nervous system metastases and/or carcinomatous meningitis
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids, or has current pneumonitis/interstitial lung disease
  • Has an active infection requiring systemic therapy
  • If infected with HIV, has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has concurrent active HBV and HCV infection
  • Has a history of stem cell/solid organ transplant

Study Design

Enrollment

55 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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).

Interventions

MK-3120

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

EV

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

Pembrolizumab

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

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).

Primary outcome measure

  • Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 27 months ]
  • Number of Participants Who Experience a Dose Limiting Toxicity (DLT) [ Time Frame: Up to approximately 21 days ]
  • Number of Participants Who Discontinue Study Treatment Due to an AE [ Time Frame: Up to approximately 24 months ]
  • Objective Response Rate (ORR) as Assessed by Investigator [ Time Frame: Up to approximately 58 months ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@msd.com

Locations

UCSF Medical Center at Mission Bay ( Site 5044)

Recruiting

San Francisco, California, United States, 94158

Contacts

Study Coordinator

415-699-7286

University of Chicago Medical Center ( Site 5037)

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Study Coordinator

773-702-1000

Cleveland Clinic Taussig Cancer ( Site 5036)

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Study Coordinator

216-444-8311

Huntsman Cancer Institute ( Site 5041)

Recruiting

Salt Lake City, Utah, United States, 84112-5550

Contacts

Study Coordinator

801-585-0155

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-09-01.