A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Clinical study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants with High-risk Stage II-IV Melanoma (INTerpath-001)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503652-27-00

Acronym

V940-001

Enrollment

596

Registered

2023-09-18

Start date

2023-10-06

Completion date

Unknown

Last updated

2025-11-25

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

Conditions

Melanoma

Brief summary

Recurrence-Free Survival (RFS)

Detailed description

Distant Metastasis Free Survival (DMFS), Overall Survival, Number of Participants Experiencing Adverse Events (AEs), Number 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

DRUGmRNA-4157

DRUGPlacebo to V940 (mRNA-4157)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Recurrence-Free Survival (RFS)	—

Secondary

Measure	Time frame
Distant Metastasis Free Survival (DMFS), Overall Survival, Number of Participants Experiencing Adverse Events (AEs), Number 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)	—

Measure

Time frame

—

Countries

Belgium, Denmark, France, Germany, Greece, Italy, Poland, Portugal, Spain, Sweden

Outcome results

None listed

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