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mRNA-4157

DRUG12 trials

Sponsors

Merck Sharp & Dohme LLC, ModernaTX, Inc.

Conditions

Bladder cancerIIIAIIIB (N2) Non-small Cell Lung CancerIntermediate-high -risk RCCMelanomaMuscle-invasive Urothelial CarcinomaNon-Small Cell Lung CancerNon-small cell lung cancer stage IV

Phase 1

Phase 2

An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942)
Active, not recruitingNCT03897881
ModernaTX, Inc.Melanoma
Start: 2019-07-18End: 2032-11-30Updated: 2025-12-03
A Phase 2, Randomized, Double-blind, Clinical Study of V940 (mRNA-4157) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in the Adjuvant Treatment of Participants With Renal Cell Carcinoma (INTerpath-004)
Active, not recruitingCTIS2023-505177-32-00
Merck Sharp & Dohme LLChigh-risk RCC who have undergone nephrectomy, Intermediate-high -risk RCC, or M1 NED RCC who have undergone nephrectomy and metastasectomy.
Start: 2024-07-31Target: 101Updated: 2026-01-26
A Phase 1/2 Study of V940 Plus Pembrolizumab With or Without Enfortumab Vedotin in Muscle-Invasive Urothelial Carcinoma (MIUC) (INTerpath-005)
Active, not recruitingCTIS2023-505658-17-00
Merck Sharp & Dohme LLCMuscle-invasive Urothelial Carcinoma
Start: 2024-04-16Target: 90Updated: 2025-10-06
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).
Active, not recruitingCTIS2023-505712-37-00
Merck Sharp & Dohme LLCThe 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).
Start: 2024-06-06Target: 242Updated: 2025-08-15
A Phase 2 Open-label Randomized Study of V940 in Combination With BCG Versus BCG Monotherapy in Participants With High-risk Non-muscle Invasive Bladder Cancer (INTerpath-011)
RecruitingCTIS2024-517335-46-00
Merck Sharp & Dohme LLCBladder cancer
Start: 2025-06-05Target: 138Updated: 2025-09-15
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)
RecruitingCTIS2024-519605-36-00
Merck Sharp & Dohme LLCMelanoma
Start: 2025-08-08Target: 97Updated: 2025-09-10
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of V940 in Combination With Pembrolizumab and Chemotherapy as First-Line Treatment for Participants With Metastatic Squamous NSCLC (INTerpath-013)
Not yet recruitingCTIS2025-520902-37-00
Merck Sharp & Dohme LLCNon-small cell lung cancer stage IV
Target: 15Updated: 2026-03-23

Phase 3

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)
Active, not recruitingCTIS2023-503652-27-00
Merck Sharp & Dohme LLCMelanoma
Start: 2023-10-06Target: 596Updated: 2025-11-25
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 Resected Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer (INTerpath-002)
RecruitingCTIS2023-504923-20-00
Merck Sharp & Dohme LLCIIIA, IIIB (N2) Non-small Cell Lung Cancer, Stage II
Start: 2024-04-04Target: 420Updated: 2025-07-02
A Phase 3 Randomized Double-blind Study of Adjuvant Pembrolizumab With or Without V940 in Participants With Resectable Stage II to IIIB (N2) NSCLC not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy (INTerpath-009)
RecruitingCTIS2023-506327-29-00
Merck Sharp & Dohme LLCNon-Small Cell Lung Cancer
Start: 2025-05-14Target: 473Updated: 2025-09-21
A Phase 3, Randomized, Placebo-Controlled Study of Adjuvant Intismeran Autogene Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) or Intismeran Autogene Monotherapy Versus Placebo in Participants With Completely Resected High-Risk Stage I Non-Small Cell Lung Cancer (INTerpath-014)
RecruitingCTIS2025-522643-18-00
Merck Sharp & Dohme LLCStage I NSCLC
Target: 137Updated: 2026-06-17

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