Clinical Trial of experimental treatments plus EV Plus Pembro for UC

• Research type

  Research Study

• Full title

  A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Study of Investigational Agents in Combination With Enfortumab Vedotin Plus Pembrolizumab as First-Line Treatment in Participants With Locally Advanced or Metastatic Urothelial Carcinoma: KEYMAKER-U04–Substudy 04D

• IRAS ID

  1012911

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT07232602

• Research summary

  Researchers are looking for new ways to treat participants with locally advanced or metastatic urothelial cancer (UC). UC is cancer that starts in the cells that line parts of the urinary tract.

  The standard treatment for locally advanced or metastatic UC is enfortumab vedotin (EV) given with pembrolizumab. EV is an antibody drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells.
  Researchers are looking at combining new trial treatments with standard treatment to treat UC. Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer. MK-3120 is an ADC and is a new trial treatment included in this trial.

  About 55 participants with locally advanced or metastatic UC, aged 18 years or older will take part in this trial if they can give a small sample of cancer tissue and do not have certain health conditions.

  All participants will receive these 3 medicines into a vein as an intravenous (IV) infusion:
  - MK-3120
  - EV
  - Pembrolizumab

  Researchers will first give the trial treatment with standard treatment to a small group of participants to help find the dose level participants can receive with standard treatment. Researchers will start with one dose level of trial treatment with the standard treatment and check for safety concerns before giving a higher dose level. They will check for safety concerns again until they find the dose level to give a larger group of participants.

  Both the participants in the trial and the researchers will know the treatment a participant is getting. Participants will provide urine and blood samples, have tumour and imaging tests and have physical and eye examinations. A participant may be in this trial for about 4 years.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  26/EE/0023

• Date of REC Opinion

  6 Feb 2026

• REC opinion

  Further Information Favourable Opinion