Phase 2 Study of Adjuvant V940 & Pembrolizumab in Renal Cell Carcinoma

• Research type

  Research Study

• Full title

  A Phase 2, Randomized, Double-blind, Clinical Study of V940 (mRNA-4157) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in the Adjuvant Treatment of Participants With Renal Cell Carcinoma.

• IRAS ID

  1008516

• Contact name

  - -

• Contact email

  NA

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT06307431

• Research summary

  Researchers continue to look for improved ways to treat renal cell carcinoma (RCC), the most common type of kidney cancer. People with RCC often have surgery to remove the cancer. After surgery, people who have a high chance of cancer returning receive more treatment.

  This trial is testing V940 (mRNA-4157) treatment given in combination with pembrolizumab in people who had surgery to remove their RCC.

  V940 is designed to help a person’s immune system attack their specific cancer. Each V940 treatment used in this trial will be custom made for the participant by using a blood sample and tumour tissue sample from their RCC.
  V940 is an experimental Advanced Therapy Medicinal Product (ATIMP). Pembrolizumab has not been approved for use with V940 to treat any type of cancer.

  Eligible participants will have an equal chance of receiving either V940 plus pembrolizumab (Arm A) or placebo plus pembrolizumab (Arm B). Approximately 296 participants will take part in the trial and participants are expected to be in the trial for 8 years.

  All participants must provide a tumour sample from the surgery that removed the RCC and a blood sample. Both the blood and tumour samples are required for next generation sequencing and for design of the participant’s treatment, which will only be made for those participants randomly assigned to Arm A.

  Participants will be in the treatment phase for about 1 year. Pembrolizumab is given as intravenous infusion once every 6 weeks for a total of 9 cycles. V940 and the placebo are injections given once every 3 weeks for a total of 9 doses. During the trial, participants will undergo procedures such as physical examinations, ECGs, blood/urine samples and scans.

  After the participant stops getting the trial treatment, they will enter the follow-up phase for about 6 years.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  24/SC/0092

• Date of REC Opinion

  21 May 2024

• REC opinion

  Further Information Favourable Opinion