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A Phase 2/3, 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
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505712-37-00
Acronym
V940-007
Enrollment
242
Registered
2024-05-23
Start date
2024-06-06
Completion date
Unknown
Last updated
2025-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The participants must have a histologically confirmed diagnosis of resectable cSCC as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted).

Brief summary

Event-Free Survival

Detailed description

Objective Response, Freedom from surgery, Pathological Complete Response, Major Pathological Response, Disease-Free Survival, Disease-Specific Survival, Overall Survival, Percentage of Participants Experiencing Adverse Events (AEs), Percentage of Participants Discontinuing Study Treatment Due to AEs, Change in score from baseline evaluated by: - Global Health Status/Quality of Life (QoL) score (QLQ-C30 Items 29 and 30), Change in score from baseline evaluated by: - Physical functioning score (QLQ-C30 Items 1 to 5), Change in score from baseline evaluated by: - Role functioning score (QLQ-C30 Items 6 and 7)

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Event-Free Survival

Secondary

MeasureTime frame
Objective Response, Freedom from surgery, Pathological Complete Response, Major Pathological Response, Disease-Free Survival, Disease-Specific Survival, Overall Survival, Percentage of Participants Experiencing Adverse Events (AEs), Percentage of Participants Discontinuing Study Treatment Due to AEs, Change in score from baseline evaluated by: - Global Health Status/Quality of Life (QoL) score (QLQ-C30 Items 29 and 30), Change in score from baseline evaluated by: - Physical functioning score (QLQ-C30 Items 1 to 5), Change in score from baseline evaluated by: - Role functioning score (QLQ-C30 Items 6 and 7)

Countries

Belgium, Czechia, France, Germany, Hungary, Italy, Norway, Poland, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026