Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06295809
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-02-29
Brief Title:
A Study of NeoAdjuvant V940 and Pembrolizumab in Cutaneous Squamous Cell Carcinoma V940-007
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase 23 Adaptive Randomized Open-label Clinical Study to Evaluate Neoadjuvant and Adjuvant V940 mRNA-4157 in Combination With Pembrolizumab MK-3475 Versus Standard of Care and Pembrolizumab Monotherapy in Participants With Resectable Locally Advanced Cutaneous Squamous Cell Carcinoma LA cSCC INTerpath-007
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a two-part Phase 2Phase 3 study of V940 an individualized neoantigen therapy INT plus pembrolizumab in participants with locally resectable advanced cutaneous squamous cell carcinoma LA cSCC Phase 2 has three arms V940 plus pembrolizumab given as neoadjuvant and adjuvant treatment with standard of care SOC standard of care surgical resection withwithout adjuvant radiation therapy RT only at investigators discretion and pembrolizumab monotherapy given as neoadjuvant and adjuvant treatment with SOC This phase will assess the safety and efficacy of V940 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 V940 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 V940 plus pembrolizumab with SOC and SOC only without changing the inclusionexclusion criteria for the additional enrollment or study endpoints
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-505712-37 | OTHER | None | None |
| U1111-1292-3589 | OTHER | None | None |
| V940 | OTHER | Merck | None |