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A Study of (Neo)Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Cutaneous Squamous Cell Carcinoma (V940-007)
NCT06295809 · View on ClinicalTrials.gov ↗
Study Summary
This is a two-part (Phase 2/Phase 3) study of intismeran autogene, an individualized neoantigen therapy (INT), plus pembrolizumab in participants with locally resectable advanced cutaneous squamous cell carcinoma (LA cSCC). Phase 2 has three arms intismeran autogene plus pembrolizumab given as neoadjuvant and adjuvant treatment with standard of care (SOC), standard of care (surgical resection with/without adjuvant radiation therapy (RT) only at investigator's discretion) and pembrolizumab monotherapy given as neoadjuvant and adjuvant treatment with SOC. This phase will assess the safety and efficacy of intismeran autogene in combination with pembrolizumab as neoadjuvant and adjuvant therapy in participants with resectable LA cSCC as compared to standard of care SOC only. The primary hypothesis is that intismeran autogene plus pembrolizumab with SOC is superior to SOC only with respect to event free survival (EFS) as assessed by the investigator. Phase 3 expansion will be determined by prespecified Go-No-Go decision in which 412 additional participants will be randomized to intismeran autogene plus pembrolizumab with SOC and SOC only, without changing the inclusion/exclusion criteria for the additional enrollment or study endpoints. As of Amendment 04, enrollment was stopped and there will be no Phase 3 expansion.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- PROCEDURE Surgery
- BIOLOGICAL Intismeran autogene
Study Locations (20)
California
- USC/Norris Comprehensive Cancer Center ( Site 1112) — Los Angeles
- Hoag Memorial Hospital Presbyterian ( Site 1122) — Newport Beach
- Stanford Cancer Center ( Site 1109) — Palo Alto
- University of California Davis (UC Davis) Comprehensive Cancer Center ( Site 1103) — Sacramento
Massachusetts
- Massachusetts General Hospital ( Site 1162) — Boston
- Dana-Farber Cancer Institute ( Site 1130) — Boston
New Jersey
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 1125) — Hackensack
- Atlantic Health System Morristown Medical Center ( Site 1136) — Morristown
New York
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 1160) — Mineola
- Laura and Isaac Perlmutter Cancer Center ( Site 1121) — New York
Virginia
- University of Virginia Health System ( Site 1115) — Charlottesville
- Inova Schar Cancer Institute ( Site 1108) — Fairfax
Georgia
- Winship Cancer Institute, Emory University ( Site 1151) — Atlanta
Iowa
- University of Iowa-Holden Comprehensive Cancer Center ( Site 1118) — Iowa City
Kentucky
- University of Kentucky Chandler Medical Center ( Site 1101) — Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2024-04-18 |
| Est. Completion | 2026-03-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06295809
The ClinicalTrials.gov registry entry for NCT06295809 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 46 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 2 conditions, with Carcinoma, Squamous Cell 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: NCT06295809 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Massachusetts, New Jersey. 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 NCT06295809 about?
NCT06295809 is a clinical study titled "A Study of (Neo)Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Cutaneous Squamous Cell Carcinoma (V940-007)". This is a two-part (Phase 2/Phase 3) study of intismeran autogene, an individualized neoantigen therapy (INT), plus pembrolizumab in participants with locally resectable advanced cutaneous squamous cell carcinoma (LA cSCC). Phase 2 has three arms intismeran autogene plus pembrolizumab given as neoad...
What is the current status of trial NCT06295809?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2024-04-18. Estimated completion is 2026-03-05.
What conditions does trial NCT06295809 study?
This clinical trial studies the following conditions: Carcinoma, Squamous Cell, Skin Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06295809?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Surgery (PROCEDURE), Intismeran autogene (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06295809?
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 NCT06295809 being conducted?
This trial has 20 study locations across California, Georgia, Iowa, Kentucky, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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