Phase 3 Study of Adjuvant V940 and Pembrolizumab in Resected Melanoma

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Clinical study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With High-Risk Stage II-IV Melanoma

• IRAS ID

  1007665

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Research summary

  This trial is testing the V940 (mRNA-4157) vaccine given in combination with pembrolizumab in people who have surgery to remove their malignant melanoma (stage 2 – 4).

  V940 is a type of vaccine known as messenger ribonucleic acid (mRNA). This type of vaccine uses the genes in cancer to teach the immune system to fight the cancer. Each V940 vaccine used in this trial will be custom made for the participant receiving it by using a tumour tissue sample from their melanoma and a blood sample. V940 is not gene therapy.
  Pembrolizumab has not been approved for use with V940 to treat any type of cancer.

  Eligible participants will be randomly assigned in a 2:1 ratio to receive treatment with either V940 plus pembrolizumab (Arm A) or placebo plus pembrolizumab (Arm B). Approximately 1089 participants will take part in the trial and participants are expected to be in the trial for 7 years.

  All participants must provide a blood and tumour sample as soon as possible after consent. A Limited Screening consent will be available for participants considering the trial before or around the time of their surgery. Both the blood and tumour samples are required for next generation sequencing and for design of the participant’s vaccine, 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 treatments. 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 drug/vaccine, they will enter the follow-up phase for about 6 years.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  23/SC/0215

• Date of REC Opinion

  5 Sep 2023

• REC opinion

  Further Information Favourable Opinion