Adding MK-3120 to enfortumab vedotin and pembrolizumab for advanced urothelial (bladder) cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This substudy of the KEYMAKER-U04 master protocol gives MK-3120 together with the established combination of enfortumab vedotin and pembrolizumab to adults with locally advanced unresectable or metastatic urothelial carcinoma. Phase 1 focuses on safety, tolerability, and identifying a recommended dose, and phase 2 examines anti-tumor activity such as response rate. Eligible participants must provide a newly obtained or archival tumor tissue sample and must not have received prior systemic therapy for advanced disease. The trial is sponsored by Merck and is being run at multiple U.S. cancer centers.

Why it matters

Who can join: the full rules

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

Where it's running

• UCSF Medical Center at Mission Bay ( Site 5044)
  San Francisco, California, United States Recruiting
• University of Chicago Medical Center ( Site 5037)
  Chicago, Illinois, United States Recruiting
• Memorial Sloan Kettering Cancer Center ( Site 5031)
  New York, New York, United States Recruiting
• Cleveland Clinic Taussig Cancer ( Site 5036)
  Cleveland, Ohio, United States Recruiting
• Huntsman Cancer Institute ( Site 5041)
  Salt Lake City, Utah, United States Recruiting
• Fundación Arturo López Pérez ( Site 5151)
  Santiago, Region M. de Santiago, Chile Recruiting

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Bladder cancer: test a biomarker-guided plan after neoadjuvant therapy

  This phase 2 study tests a biomarker- and response-guided plan to preserve the bladder in patients with muscle-invasive bladder cancer after neoadjuvant therapy.

  Recruiting Phase 2 Fox Chase Cancer Center · Philadelphia, Pennsylvania · NCT07908979

• Combining enfortumab vedotin and pembrolizumab with radiation for muscle invasive bladder cancer

  This study is testing a new combination of a drug and radiation therapy to see if it helps people with muscle invasive bladder cancer who want to avoid surgery.

  Recruiting Phase 1/2 University of California, San Francisco · San Francisco, California · NCT06470282

• Combination therapy for high grade upper tract urothelial cancer patients refusing surgery

  This study is testing if a combination of two cancer drugs can help people with high grade upper tract urothelial cancer who don't want surgery live longer without their cancer getting worse.

  Recruiting at 2 sites Phase 2 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Washington D.C., District of Columbia and 1 other locations · NCT05656235

• Sacituzumab govitecan plus enfortumab vedotin for metastatic urothelial cancer

  This trial tests whether combining sacituzumab govitecan and enfortumab vedotin, with pembrolizumab in some patients, helps people with metastatic urothelial carcinoma who have progressed after platinum chemotherapy and PD‑1/PD‑L1 inhibitors.

  Recruiting Phase 1/2 Dana-Farber Cancer Institute · Boston, Massachusetts · NCT04724018

• Peripheral neuropathy during perioperative therapy with enfortumab vedotin and pembrolizumab in muscle-invasive urothelial cancer

  This study follows adults with muscle-invasive urothelial cancer to see how nerve-related side effects develop when people receive enfortumab vedotin and pembrolizumab around surgery as part of standard care.

  Recruiting at 3 sites Comprehensive Cancer Center Munich (CCCM) · Munich, Bavaria and 2 other locations · NCT07870577

• Sac-TMT and pembrolizumab with chemoradiation for bladder muscle invasion

  This trial tests whether adding Sac-TMT and pembrolizumab to chemoradiation helps people with muscle-invasive bladder cancer live longer without the cancer growing or returning.

  Recruiting at 10 sites Phase 3 Merck Sharp & Dohme LLC · Kaohsiung City and 9 other locations · NCT07829783

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.