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Vusolimogene oderparepvec

DRUG6 trials

Sponsors

Institut Curie, Replimune Inc., Replimune Group Inc.

Conditions

Advanced MelanomaAdvanced solid tumorsCutaneous Squamous Cell CarcinomaHepatocellular CarcinomaMelanomaMetastatic MelanomaPatients with early-stage Triple Negative Breast CancerSolid tumors

Phase 1

An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination with PD1 Blockade in Patients with Solid Tumors
Active, not recruitingCTIS2024-511728-15-00
Replimune Group Inc.Solid tumors
Start: 2021-08-26Target: 81Updated: 2025-06-04

Phase 2

"neoBREASTIM": A Phase 2 Study of Atezolizumab plus RP1 oncolytic immunotherapy in the NeoAdjuvant setting of Triple-Negative Breast Cancer (TNBC)
CompletedCTIS2022-502311-12-00
Institut CuriePatients with early-stage Triple Negative Breast Cancer
Start: 2024-04-05End: 2025-05-07Target: 51Updated: 2025-01-17
A Randomized, Controlled, Open-Label, Phase 2 Study of Cemiplimab as a Single Agent and in Combination With RP1 in Patients With Advanced Cutaneous Squamous Cell Carcinoma [CERPASS]
CompletedCTIS2024-512652-38-00
Replimune Group Inc.Cutaneous Squamous Cell Carcinoma
Start: 2021-01-25End: 2026-01-14Target: 143Updated: 2026-01-27

Phase 3

VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs [IGNYTE-3]
RecruitingNCT06264180
Replimune Inc.Advanced Melanoma
Start: 2024-07-11End: 2034-08-31Target: 400Updated: 2026-03-13
A Randomized, Controlled, Multicenter, Phase 3 Clinical Study Comparing Vusolimogene Oderparepvec in Combination with Nivolumab Versus Treatment of Physician’s Choice in Patients with Advanced Melanoma That Has Progressed on an Anti-PD-1 and an Anti-CTLA-4 Containing Treatment Regimen [IGNYTE-3]
RecruitingCTIS2023-508612-29-00
Replimune Inc.Advanced Melanoma
Start: 2025-11-07Target: 193Updated: 2025-11-04

Phase 4

Long-term Safety Outcomes in Patients Treated With Replimune Oncolytic Immunotherapy Products
Not yet recruitingCTIS2025-521621-33-00
Replimune Group Inc.Advanced solid tumors, Hepatocellular Carcinoma, Melanoma +1
Target: 13Updated: 2026-02-09

Related Papers

A randomized, controlled, multicenter, phase 3 study of vusolimogene oderparepvec combined with nivolumab vs treatment of physician’s choice in patients with advanced melanoma that has progressed on anti–PD-1 and anti–CTLA-4 therapy (IGNYTE-3).
Journal of Clinical Oncology2025-05-28
A randomized, controlled, multicenter, phase 3 study of vusolimogene oderparepvec (VO) combined with nivolumab vs treatment of physician’s choice in patients with advanced melanoma that has progressed on anti–PD-1 and anti–CTLA-4 therapy (IGNYTE-3).
Journal of Clinical Oncology2024-06-016 citations