^
    3d
    Phase I study of a recombinant attenuated oncolytic virus, MEDI5395 (NDV-GM-CSF), administered systemically in combination with durvalumab in patients with advanced solid tumors. (PubMed, J Immunother Cancer)
    This study demonstrates the feasibility, safety and preliminary efficacy of MEDI5395 with durvalumab in patients with advanced solid tumors.
    P1 data • Journal • Combination therapy • Oncolytic virus • Metastases
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CSF2 (Colony stimulating factor 2)
    |
    Imfinzi (durvalumab) • MEDI5395
    over1year
    A Study of MEDI5395 in Combination With Durvalumab in Participants With Select Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=39, Completed, MedImmune LLC | Active, not recruiting --> Completed
    Trial completion • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8)
    |
    PD-L1 expression
    |
    Imfinzi (durvalumab) • MEDI5395
    over2years
    A Study of MEDI5395 in Combination With Durvalumab in Subjects With Select Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=39, Active, not recruiting, MedImmune LLC | Trial completion date: May 2023 --> Dec 2022
    Trial completion date • Combination therapy
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • CSF2 (Colony stimulating factor 2)
    |
    PD-L1 expression
    |
    Imfinzi (durvalumab) • MEDI5395
    almost3years
    A Study of MEDI5395 in Combination With Durvalumab in Subjects With Select Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=39, Active, not recruiting, MedImmune LLC | Trial primary completion date: May 2023 --> Nov 2021
    Clinical • Trial primary completion date • Combination therapy
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • CSF2 (Colony stimulating factor 2)
    |
    PD-L1 expression
    |
    Imfinzi (durvalumab) • MEDI5395
    3years
    A Study of MEDI5395 in Combination With Durvalumab in Subjects With Select Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=38, Active, not recruiting, MedImmune LLC | Recruiting --> Active, not recruiting | N=188 --> 38 | Trial completion date: May 2025 --> May 2023 | Trial primary completion date: May 2025 --> May 2023
    Clinical • Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • CSF2 (Colony stimulating factor 2)
    |
    PD-L1 expression
    |
    Imfinzi (durvalumab) • MEDI5395
    over4years
    A Study of MEDI5395 in Combination With Durvalumab in Subjects With Select Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=164, Recruiting, MedImmune LLC | Active, not recruiting --> Recruiting
    Clinical • Enrollment open • Combination therapy
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • CSF2 (Colony stimulating factor 2)
    |
    PD-L1 expression
    |
    Imfinzi (durvalumab) • MEDI5395
    over4years
    A Study of MEDI5395 in Combination With Durvalumab in Subjects With Select Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=164, Active, not recruiting, MedImmune LLC | Recruiting --> Active, not recruiting
    Clinical • Enrollment closed • Combination therapy
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • CSF2 (Colony stimulating factor 2)
    |
    PD-L1 expression
    |
    Imfinzi (durvalumab) • MEDI5395
    over4years
    [VIRTUAL] A phase 1 study of IV MEDI5395, an oncolytic virus, in combination with durvalumab in patients with advanced solid tumors (AACR-I 2020)
    Secondary objectives include assessing MEDI5395 pharmacokinetics (viremia and GM-CSF transgene expression), pharmacodynamics in the TME, immunogenicity, and initial efficacy in combination with durvalumab. The trial is actively accruing.
    Clinical • P1 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker
    |
    IFNG (Interferon, gamma) • CSF2 (Colony stimulating factor 2)
    |
    PD-L1 expression • IFNG expression
    |
    Imfinzi (durvalumab) • MEDI5395