Phase 1/2 trial of MK-2870 plus EV and MK-3475 in Advanced UC

• Research type

  Research Study

• Full title

  A Phase 1/2 Randomized, Umbrella Study to Evaluate the Efficacy and Safety of MK-2870 Plus Enfortumab Vedotin (EV) With and Without Pembrolizumab, as Treatment for Participants With Advanced Urothelial Carcinoma (KEYMAKER-U04): Substudy 04C

• IRAS ID

  1009927

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Research summary

  Urothelial Carcinoma (UC) is a common cancer affecting 549,000 people a year worldwide. UC is a cancer in the cells that line parts of the urinary tract. Researchers are seeking new ways to treat locally advanced or metastatic UC.

  Researchers want to learn if combinations of MK-2870 (sacituzumab tirumotecan), enfortumab vedotin (EV), and pembrolizumab, can treat UC. Pembrolizumab is an immunotherapy, a treatment that helps the immune system fight cancer. MK-2870 and EV are antibody drug conjugates (ADC). An ADC attaches to specific targets on cancer cells and delivers treatment to destroy those cells.

  About 98 adults will participate. They must provide a tissue sample of the UC and must not have had another type of cancer in the past 3 years.

  All participants will receive one or two of these trial treatments by intravenous (IV) infusion:
  • MK-2870 and EV
  • Pembrolizumab

  This trial will be in two parts:
  Part 1: To test for safety and how the cancer responds and choose 2 dose levels of MK-2870 plus EV to use in Part 2.
  Part 2: Participants will be randomly assigned with equal chance to receive 1 of 2 dose levels of MK-2870 plus EV and pembrolizumab to measure safety and how the cancer responds.

  Participants will receive MK-2870 and EV twice every 3 weeks until the cancer gets worse, or they don’t tolerate it. .
  Participants will receive pembrolizumab once every 3 weeks for up to 2 years.

  Participants and the researchers will know which trial treatments participants are receiving. Participants will provide urine and blood samples and have tumour and imaging tests during the trial. They will also have physical and eye examinations and tests to check their heart.

  The trial will run for approximately 4 years.

• REC name

  Wales REC 1

• REC reference

  24/WA/0142

• Date of REC Opinion

  29 Jul 2024

• REC opinion

  Further Information Favourable Opinion