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NCT06307431 · ClinicalTrials.gov registry record · Phase 2
A Study of Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Renal Cell Carcinoma (V940-004).
A Phase 2 study of Renal Cell Carcinoma, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 2
- Development phase
- 272
- Enrollment target
- 20
- Study locations
NCT06307431: Active Phase 2 study of Renal Cell Carcinoma, sponsored by Merck Sharp & Dohme.
NCT06307431 is a Phase 2 study of Renal Cell Carcinoma that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 272 participants, above the 241-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (13% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06307431, a Phase 2 study of Renal Cell Carcinoma, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 272 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
DFS, as assessed by the investigator, is defined as the time from randomization to the first documented local recurrence, or occurrence of distant kidney cancer metastasis(es), or death due to any cause, whichever occurs first.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL Placebo
- BIOLOGICAL Intismeran autogene
Study Locations (20)
California
- City of Hope Comprehensive Cancer Center-Medical Oncology ( Site 0104) - Duarte
- UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro - Los Angeles
- UCSF Medical Center at Mission Bay ( Site 0108) - San Francisco
Massachusetts
- Beth Israel Deaconess Medical Center-Cancer Clinical Trials Office ( Site 0109) - Boston
- Dana-Farber Cancer Institute-GU ( Site 0101) - Boston
Pennsylvania
- Abramson Cancer Center ( Site 0107) - Philadelphia
- Fox Chase Cancer Center ( Site 0111) - Philadelphia
Buenos Aires F.D.
- Instituto Alexander Fleming-Alexander Fleming ( Site 1101) - Buenos Aires
- Asociación de Beneficencia Hospital Sirio Libanés ( Site 1110) - Buenos Aires
New South Wales
- Macquarie University-MQ Health Clinical Trials Unit ( Site 1502) - Macquarie University
- Westmead Hospital ( Site 1501) - Westmead
Connecticut
- Yale-New Haven Hospital-Yale Cancer Center ( Site 0102) - New Haven
New York
- Memorial Sloan Kettering Cancer Center ( Site 0100) - New York
North Carolina
- Duke Cancer Institute ( Site 0106) - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 272 participants |
| Start Date | 2024-04-10 |
| Est. Completion | 2032-06-08 |
| Phase | Phase 2 |
What the registry record for NCT06307431 still lists
NCT06307431 is an interventional study that assigns participants to a tested intervention. The registered 272 participants enrollment target is mid-sized for trials with a published cap, above the 241-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (13% higher).
The record links to 1 condition, with Renal Cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT06307431 names 20 study sites across 14 states, led by California, Massachusetts, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06307431 about?
NCT06307431 is a clinical study titled "A Study of Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Renal Cell Carcinoma (V940-004).". 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 p...
What is the current status of trial NCT06307431?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 272 participants. The study started on 2024-04-10. Estimated completion is 2032-06-08.
What conditions does trial NCT06307431 study?
This clinical trial studies the following conditions: Renal Cell Carcinoma.
What interventions are being tested in trial NCT06307431?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Placebo (BIOLOGICAL), Intismeran autogene (BIOLOGICAL).
Who is sponsoring clinical trial NCT06307431?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06307431 being conducted?
This trial has 20 study locations across California, Connecticut, Massachusetts, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06307431's enrollment target sits among peer trials
272 27th of 121 higher than 95 of 121 other Renal Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Renal Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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