EV + Pembro vs Chemo for Cisplatin-eligible MIBC

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants with Muscle-invasive Bladder Cancer (KEYNOTE-B15 / EV-304)

• IRAS ID

  1007182

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Eudract number

  2020-003106-31

• Research summary

  Bladder cancer is one of the most common malignancies in the world. Muscle-invasive bladder cancer (MIBC) is an aggressive disease for which surgery is the established standard therapy. However, approximately 40% of patients die within 3 years of diagnosis. Despite progress and promising results in advanced disease, there is an unmet need in the treatment of MIBC.

  This trial is testing enfortumab vedotin (EV) + pembrolizumab (pembro) given before and after surgery compared to chemotherapy (gemcitabine + cisplatin) before surgery in people with MIBC.
  Pembro has been approved alone or with other drugs for certain cancers. Pembro in combination with other drugs has not been approved for people with bladder cancer. EV has been approved in the USA only for people with bladder cancer.

  About 784 male and female participants aged at least 18 years of age will be enrolled in this trial.
  After a screening period of 6 weeks, eligible participants will be randomised in a 1:1 ratio into 1 of 2 treatment groups:
  Group 1: EV (twice every 3 weeks – 4 cycles before surgery and 5 cycles after surgery) + pembro (once every 3 weeks – 4 cycles before surgery and 13 cycles after surgery).
  Group 2: Chemotherapy - Gemcitabine (twice every 3 weeks) + Cisplatin (once every 3 weeks) before surgery for 4 treatment cycles.
  Participants will be in the Pre-Surgical Treatment Phase up to 16 weeks (about 4 months) and the Post-Surgical Treatment Phase up to 39 weeks (about 9 months).
  After the participants stop getting the trial drugs, they will enter the follow-up phase.

  The trial is sponsored by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (MSD).

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  23/SC/0026

• Date of REC Opinion

  16 Jun 2023

• REC opinion

  Further Information Favourable Opinion