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)

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.

Trial Details

NCT ID
NCT07232602
Phase
PHASE1 / PHASE2
Sponsor
Merck Sharp & Dohme LLC
Status
RECRUITING
Cancer Type
Urothelial Carcinoma Bladder Cancer
Interventions
  • MK-3120
  • EV
  • Pembrolizumab
  • Rescue Medication
Locations (sample)
  • San Francisco, California, United States|37.77493,-122.41942
  • Cleveland, Ohio, United States|41.4995,-81.69541
  • Salt Lake City, Utah, United States|40.76078,-111.89105
  • Bordeaux, Gironde, France|44.84124,-0.58046
  • Haifa, Israel|32.81303,34.99928

Key Eligibility 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

For full eligibility, visit ClinicalTrials.gov.

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