^
    4d
    Effects of oncolytic immunotherapy with RP1 (vusolimogene oderparepvec) on immune cells mediate responsiveness to anti-PD-1 via STING-mediated interferon signaling. (PubMed, J Immunother Cancer)
    Overall, the data demonstrate that RP1 remodels the tumor microenvironment through a combination of direct and indirect effects on both tumor and immune cells, resulting in an overall more inflamed phenotype.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    STING (stimulator of interferon response cGAMP interactor 1) • CSF2 (Colony stimulating factor 2) • ITGAM (Integrin, alpha M) • IFNAR1 (Interferon (alpha, beta and omega) receptor 1)
    |
    PD-L1 expression
    |
    Tudriqev (vusolimogene oderparepvec-wtpg)
    7d
    ARTACUS: Study to Investigate the Efficacy and Safety of RP1 in Adult Patients With Organ Transplants and Advanced Skin Malignancies (clinicaltrials.gov)
    P1/2, N=90, Recruiting, Replimune Inc. | N=65 --> 90 | Trial completion date: Jan 2028 --> Nov 2029 | Trial primary completion date: Sep 2027 --> Jul 2029
    Enrollment change • Trial completion date • Trial primary completion date
    |
    Tudriqev (vusolimogene oderparepvec-wtpg)
    18d
    RPL-123-01: A Study to Assess the Long-term Safety Outcomes in Patients Previously Treated With RP1, RP2, or RP3 (2025-521621-33-00)
    P4, N=41, Not yet recruiting, Replimune Group Inc.
    New P4 trial
    |
    RP3 • Tudriqev (vusolimogene oderparepvec-wtpg) • sturlimogene erparepvec (RP2)
    21d
    Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE) (clinicaltrials.gov)
    P2, N=340, Active, not recruiting, Replimune Inc. | Trial primary completion date: Dec 2025 --> Jun 2028
    Trial primary completion date
    |
    BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR • BRAF mutation
    |
    Opdivo (nivolumab) • Tudriqev (vusolimogene oderparepvec-wtpg)
    2ms
    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, Recruiting, Replimune Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    RP3 • Tudriqev (vusolimogene oderparepvec-wtpg) • sturlimogene erparepvec (RP2)
    3ms
    Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE) (clinicaltrials.gov)
    P2, N=340, Active, not recruiting, Replimune Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR • BRAF mutation
    |
    Opdivo (nivolumab) • Tudriqev (vusolimogene oderparepvec-wtpg)
    7ms
    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)
    8ms
    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)
    9ms
    "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)
    11ms
    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)
    12ms
    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)
    1year
    Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE) (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)