^
    4ms
    RPx: A Study to Assess the Long-term Safety Outcomes in Patients Previously Treated With RP1, RP2, or RP3 (clinicaltrials.gov)
    P=N/A, N=50, Not yet recruiting, Replimune Inc. | Initiation date: Jun 2025 --> Nov 2025
    Trial initiation date
    |
    RP3 • Tudriqev (vusolimogene oderparepvec-wtpg) • sturlimogene erparepvec (RP2)
    5ms
    RP1 Combined With Nivolumab in Advanced Anti-PD-1-Failed Melanoma (IGNYTE). (PubMed, J Clin Oncol)
    RP1 combined with nivolumab provided deep and durable systemic responses in patients with anti-PD-1-failed melanoma, including those with poor prognostic factors. The safety profile was favorable, with mostly grade 1/2 adverse events. (Funded by Replimune, Inc.; IGNYTE ClinicalTrials.gov, NCT03767348; EudraCT number, 2016-004548-12).
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8)
    |
    PD-L1 expression • PD-L1 negative
    |
    Opdivo (nivolumab) • Tudriqev (vusolimogene oderparepvec-wtpg)
    6ms
    "neoBREASTIM": Atezolizumab Plus RP1 Oncolytic Immunotherapy in the NeoAdjuvant Setting of Triple-Negative Breast Cancer (clinicaltrials.gov)
    P1/2, N=2, Terminated, Institut Curie | N=51 --> 2 | Trial completion date: Apr 2031 --> May 2025 | Recruiting --> Terminated | Trial primary completion date: Apr 2026 --> May 2025; insufficient recruitment
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HER-2 overexpression
    |
    Tecentriq (atezolizumab) • Tudriqev (vusolimogene oderparepvec-wtpg)
    8ms
    RP1 in Primary Melanoma to Reduce the Risk of Sentinel Lymph Node Metastasis (clinicaltrials.gov)
    P1, N=25, Recruiting, Yana Najjar | Trial completion date: Jul 2028 --> Mar 2027
    Trial completion date
    |
    Tudriqev (vusolimogene oderparepvec-wtpg)
    9ms
    RPx: A Study to Assess the Long-term Safety Outcomes in Patients Previously Treated With RP1, RP2, or RP3 (clinicaltrials.gov)
    P=N/A, N=50, Not yet recruiting, Replimune Inc.
    New trial
    |
    RP3 • Tudriqev (vusolimogene oderparepvec-wtpg) • sturlimogene erparepvec (RP2)
    11ms
    IGNYTE: Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (clinicaltrials.gov)
    P2, N=340, Recruiting, Replimune Inc. | Trial completion date: Jun 2025 --> Dec 2028 | Trial primary completion date: Jun 2025 --> Dec 2025
    Trial completion date • Trial primary completion date
    |
    BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR • BRAF mutation
    |
    Opdivo (nivolumab) • Tudriqev (vusolimogene oderparepvec-wtpg)
    11ms
    IGNYTE: Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (clinicaltrials.gov)
    P2, N=340, Recruiting, Replimune Inc. | Trial completion date: Nov 2024 --> Jun 2025 | Trial primary completion date: Nov 2024 --> Jun 2025
    Trial completion date • Trial primary completion date
    |
    BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR • BRAF mutation
    |
    Opdivo (nivolumab) • Tudriqev (vusolimogene oderparepvec-wtpg)
    1year
    RPL-EAP-001: An Expanded Access Program for VO (RP1) in Combination With Nivolumab in Patients With Advanced Melanoma (clinicaltrials.gov)
    P=N/A, N=0, Available, Replimune Inc.
    New trial • Combination therapy • Real-world evidence • Real-world • Metastases
    |
    Opdivo (nivolumab) • Tudriqev (vusolimogene oderparepvec-wtpg)
    over1year
    VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs (IGNYTE-3) (clinicaltrials.gov)
    P3, N=400, Recruiting, Replimune Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • temozolomide • albumin-bound paclitaxel • Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016) • Tudriqev (vusolimogene oderparepvec-wtpg)
    over1year
    "neoBREASTIM": Atezolizumab Plus RP1 Oncolytic Immunotherapy in the NeoAdjuvant Setting of Triple-Negative Breast Cancer (clinicaltrials.gov)
    P1/2, N=51, Recruiting, Institut Curie | Not yet recruiting --> Recruiting | Initiation date: Dec 2023 --> Apr 2024
    Enrollment open • Trial initiation date • Oncolytic virus
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Tecentriq (atezolizumab) • Tudriqev (vusolimogene oderparepvec-wtpg)
    almost2years
    RP1 in Primary Melanoma to Reduce the Risk of Sentinel Lymph Node Metastasis (clinicaltrials.gov)
    P1, N=25, Recruiting, Yana Najjar | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Tudriqev (vusolimogene oderparepvec-wtpg)
    almost2years
    VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs (IGNYTE-3) (clinicaltrials.gov)
    P3, N=400, Not yet recruiting, Replimune Inc.
    New P3 trial • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • temozolomide • albumin-bound paclitaxel • Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016) • Tudriqev (vusolimogene oderparepvec-wtpg)