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Intismeran autogene

BIOLOGICAL9 trials

Sponsors

Merck Sharp & Dohme LLC

Conditions

Bladder CancerCarcinoma in SituCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellMalignant MelanomaMelanomaNon-Muscle Invasive Bladder NeoplasmsNon-small Cell Lung Cancer

Phase 1

A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005)
Active, not recruitingNCT06305767
Merck Sharp & Dohme LLCBladder Cancer
Start: 2024-03-28End: 2031-10-20Target: 230Updated: 2026-01-13

Phase 2

A Study of (Neo)Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Cutaneous Squamous Cell Carcinoma (V940-007)
TerminatedNCT06295809
Merck Sharp & Dohme LLCCarcinoma, Squamous Cell, Skin Neoplasms
Start: 2024-04-18End: 2026-03-05Updated: 2026-05-08
A Study of Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Renal Cell Carcinoma (V940-004).
Active, not recruitingNCT06307431
Merck Sharp & Dohme LLCRenal Cell Carcinoma
Start: 2024-04-10End: 2032-06-08Target: 272Updated: 2026-07-13
A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011)
RecruitingNCT06833073
Merck Sharp & Dohme LLCCarcinoma in Situ, Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms
Start: 2025-03-11End: 2031-09-03Target: 308Updated: 2026-09-14
A Clinical Study of Intismeran Autogene (V940) and Pembrolizumab (MK-3475) in People With Melanoma (V940-012/INTerpath-012)
RecruitingNCT06961006
Merck Sharp & Dohme LLCMalignant Melanoma
Start: 2025-05-29End: 2031-09-05Target: 160Updated: 2026-07-02
A Study of Intismeran Autogene (V940)/Placebo + Pembrolizumab and Chemotherapy in Metastatic Squamous Non-Small Cell Lung Cancer (V940-013)
RecruitingNCT07221474
Merck Sharp & Dohme LLCSquamous Non-small Cell Lung Cancer
Start: 2025-12-12End: 2031-05-06Target: 180Updated: 2026-08-21

Phase 3

A Clinical Study of Intismeran Autogene (V940) Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)
Active, not recruitingNCT05933577
Merck Sharp & Dohme LLCMelanoma
Start: 2023-07-19End: 2030-09-26Target: 1089Updated: 2025-09-24
A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)
Active, not recruitingNCT06077760
Merck Sharp & Dohme LLCNon-small Cell Lung Cancer
Start: 2023-12-06End: 2035-12-21Target: 868Updated: 2026-09-18
A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)
RecruitingNCT06623422
Merck Sharp & Dohme LLCCarcinoma, Non-Small-Cell Lung
Start: 2024-10-21End: 2038-01-26Target: 680Updated: 2026-09-18

Related Papers

Individualized neoantigen therapy intismeran autogene (intismeran) plus pembrolizumab (pembro) in resected melanoma: 5-year update of the KEYNOTE-942 study.
Journal of Clinical Oncology2026-05-28
INTerpath-013: A phase 2, randomized, double-blind study of intismeran autogene plus pembrolizumab and chemotherapy as first-line treatment for metastatic squamous non–small cell lung cancer.
Journal of Clinical Oncology2026-05-28
Neoantigen-based cancer vaccines: a mechanistic and clinical review of personalised melanoma immunotherapy
Frontiers in Immunology2026-04-02
Radiological, Pathological, and Surgical Outcomes with Neoadjuvant Cemiplimab for Stage II–IV Cutaneous Squamous Cell Carcinoma in the Deep Sequencing in Cutaneous Squamous Cell Carcinomas (DISCERN) Trial
Cancers2025-05-213 citations
Abstract CT251: Phase 3 INTerpath-009 study: Individualized neoantigen therapy V940 (mRNA-4157) plus pembrolizumab for resected stage II-IIIB (N2) NSCLC with incomplete pathological response to neoadjuvant immunochemotherapy
Cancer Research2025-04-252 citations
Phase 1/2 INTerpath-005 study: V940 (mRNA-4157) plus pembrolizumab with or without enfortumab vedotin (EV) for resected high-risk muscle-invasive urothelial carcinoma (MIUC).
Journal of Clinical Oncology2025-02-104 citations
INTerpath-004: A phase 2, randomized, double-blind study of adjuvant pembrolizumab (pembro) with V940 (mRNA-4157) or placebo for renal cell carcinoma (RCC).
Journal of Clinical Oncology2025-02-102 citations
45 INTerpath-004: A phase 2, randomized, double-blind study of pembrolizumab with V940 (mRNA-4157) or placebo in the adjuvant treatment of renal cell carcinoma
The Oncologist2024-08-054 citations
INTerpath-001: Pembrolizumab with V940 (mRNA-4157) versus pembrolizumab with placebo for adjuvant treatment of high-risk stage II-IV melanoma.
Journal of Clinical Oncology2024-06-0111 citations
The phase 3 INTerpath-002 study design: Individualized neoantigen therapy (INT) V940 (mRNA-4157) plus pembrolizumab vs placebo plus pembrolizumab for resected early-stage non–small-cell lung cancer (NSCLC).
Journal of Clinical Oncology2024-06-0111 citations
Abstract CT281: The phase 3 INTerpath-002 study design: Individualized neoantigen therapy (INT) V940 (mRNA-4157) plus pembrolizumab vs placebo plus pembrolizumab for resected early-stage non-small-cell lung cancer (NSCLC)
Cancer Research2024-04-051 citations