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A Phase 2, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Clinical Study of V940 (mRNA-4157) Plus Pembrolizumab Versus Placebo Plus Pembrolizumab in Participants in First-Line Metastatic Melanoma (INTerpath-012)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519605-36-00
Acronym
V940-012
Enrollment
97
Registered
2025-07-30
Start date
2025-08-08
Completion date
Unknown
Last updated
2025-09-10

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

Conditions

Melanoma

Brief summary

Progression-free survival (PFS)

Detailed description

Objective Response (OR), Duration of Response (DOR), Overall Survival (OS), Number of participants with ≥1 adverse event (AE), Number of participants discontinuing from study therapy due to AE

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
Progression-free survival (PFS)

Secondary

MeasureTime frame
Objective Response (OR), Duration of Response (DOR), Overall Survival (OS), Number of participants with ≥1 adverse event (AE), Number of participants discontinuing from study therapy due to AE

Countries

France, Germany, Greece, Italy, Poland, Portugal, Spain

Outcome results

None listed

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