A Phase 2 Study of V940 Plus Pembrolizumab Immunotherapy to Treat Kidney Cancer

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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

Purpose

Researchers want to see how well a personalized vaccine works for people with kidney cancer when given with pembrolizumab immunotherapy. The people in this study have renal cell carcinoma that was or will be removed with surgery. In addition, the cancer has a high chance of coming back.

The vaccine is called V940 and is an “mRNA vaccine.” It is made in a way similar to the vaccines used to prevent COVID. V940 is made from mRNA taken from a tumor sample collected during surgery to remove kidney cancer. V940 uses the genes in your tumor to teach your immune system to fight your cancer. It is given as an injection into a muscle.

Pembrolizumab takes the brakes off the immune response, enabling immune cells to find and kill cancer cells. It is given intravenously (by vein).

If you join this study, you will be randomly assigned to get one of these treatments:

  • V940 plus pembrolizumab
  • Placebo (inactive drug) plus pembrolizumab

Who Can Join

To join this study, there are a few conditions. You must:

  • Have clear cell or papillary renal cell carcinoma that has not yet been treated with anti-cancer medication or radiation therapy.
  • Have or will have kidney cancer surgery within 12 weeks of getting the study therapy.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Robert Motzer’s office at 646-888-4722.

Protocol

24-109

Phase

Phase II (phase 2)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06307431