NCT06307431

A Study of Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Renal Cell Carcinoma (V940-004).

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 (INTerpath-004).

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 272 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to compare intismeran autogene plus pembrolizumab to placebo plus pembrolizumab in participants with renal cell carcinoma (RCC) with respect to disease-free survival (DFS) as assessed by the investigator. The primary hypothesis is that intismeran autogene plus pembrolizumab is superior to placebo plus pembrolizumab with respect to DFS.

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Intismeran autogene	IM injection
BIOLOGICAL	Pembrolizumab	IV infusion
BIOLOGICAL	Placebo	IM injection

Timeline

• Start date: 2024-04-10
• Primary completion: 2028-01-08
• Completion: 2032-06-08
• First posted: 2024-03-12
• Last updated: 2025-09-02

Locations

63 sites across 14 countries: United States, Argentina, Australia, Canada, Chile, France, Germany, Italy, Poland, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study