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A Study of Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Renal Cell Carcinoma (V940-004).
NCT06307431 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06307431
The ClinicalTrials.gov registry entry for NCT06307431 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 272 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06307431 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Massachusetts, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06307431?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Placebo (BIOLOGICAL), Intismeran autogene (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06307431?
This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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