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drugset / Trial / NCT06307431

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

NCT06307431 ↗

Phase 2 Active not recruiting 272 enrolled Merck Sharp & Dohme LLC ModernaTX, Inc. · collab
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2024-04-10
Primary completion
2028-01-08
Completion
2032-06-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Intismeran autogene Messenger RNA (mRNA) 1 mg Intramuscular
Background Pembrolizumab Monoclonal antibody 400 mg Intravenous

Indications

renal cell carcinoma