Phase 1/2 Study of V940 + Pembrolizumab +/- Enfortumab Vedotin in MIUC

• Research type

  Research Study

• Full title

  A Phase 1/2 Study of V940 Plus Pembrolizumab With or Without Enfortumab Vedotin in Muscle-Invasive Urothelial Carcinoma (MIUC) (INTerpath-005)

• IRAS ID

  1008372

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT06305767

• Research summary

  Researchers are looking for new ways to treat people with high-risk muscle-invasive urothelial carcinoma (MIUC).
  Researchers want to learn if giving the study treatment called V940 with pembrolizumab can prevent MIUC from returning after surgery. Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer. V940 is designed to help a person’s immune system attack their cancer. The combination of V940 and pembrolizumab is experimental. This combination has not been approved to treat any types of cancer.

  The goal of this study is to learn if people who receive V940 and pembrolizumab are alive and cancer free longer than those who receive placebo and pembrolizumab. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand if the study treatment works.
  About 200 people with MIUC will be in the study. They will be 18 years old and older and:
  • Had surgery to remove MIUC within 2 months before joining the study
  • Not have had radiation therapy or certain other cancer treatments for MIUC
  People will have an equal chance of receiving either:
  • V940 (study treatment) and pembrolizumab
  • Placebo and pembrolizumab
  People will receive V940 or placebo as an injection into the muscle every 3 weeks. They will receive a total of 9 doses.
  People will receive pembrolizumab through a needle into a vein as an infusion every 6 weeks. They will receive a total of 9 infusions.
  Neither the people in the study nor the researchers will know what treatment they are assigned (called a double-blind study). During the study, people will give blood, urine, and tumour samples. They will also have imaging tests and physical examinations.
  A person may be in this study for up to 6 years.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  24/SC/0090

• Date of REC Opinion

  23 May 2024

• REC opinion

  Further Information Favourable Opinion