Purpose of this Study
We are doing this study to find the most effective, safe dose of an experimental drug called V940 (the study drug) when it is given with pembrolizumab to people who have had surgery to remove renal cell carcinoma. We want to know how well this combination works compared to taking pembrolizumab on its own.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with renal cell carcinoma
- Have undergone complete resection of the primary tumor
- Have not received prior treatment with a cancer vaccine
- Have not received prior systemic anticancer therapy within 4 weeks before starting the study regimen
For more information about who can join this study, please contact the study team at kellie.shobe@duke.edu or 919-684-8299.
What is Involved?
Description
If you choose to join this study, you will go through a screening period to find out if you are eligible. During this screening period, you will:
- Have a physical exam
- Have an ECG
- Have blood draws
- Have a tumor biopsy
If you are eligible to join, you will get a random assignment (like a coin flip) to 1 of 2 groups:
- Group 1 will get the study drug and pembrolizumab
- Group 2 will get a placebo (inactive substance) and pembrolizumab
Pembrolizumab is given by a needle in the vein. This is called intravenous (IV) infusion. It is given once every 6 weeks for up to 9 doses over approximately 1 year.
The study drug and placebo are given as shots in a muscle (shoulder, thigh, or buttock). You will get the shots every 3 weeks up to a total of 9 doses (about 6 months).
Your length of participation will depend on how you respond to your assigned study regimen.
Study Details
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
Principal Investigator
Daniel
George
Protocol Number
PRO00114302
NCT ID
NCT06307431
Phase
II
Enrollment Status
Open to Enrollment