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    DRUG:

    lerapolturev (PVS-RIPO)

    i
    Other names: PVS-RIPO, PVSRIPO, recombinant polio virus vaccine, polio virus sabin-rhinovirus poliovirus, re-engineered poliovirus, sabin type 1 polio vaccine
    Company:
    Istari Oncology
    Drug class:
    Immunostimulant, Dendritic cell activator
    Related drugs:
    3ms
    LUMINOS-102: Lerapolturev With or Without Immune Checkpoint Blockade in Advanced PD-1 Refractory Melanoma (clinicaltrials.gov)
    P2, N=27, Completed, Istari Oncology, Inc. | Active, not recruiting --> Completed | N=56 --> 27
    Trial completion • Enrollment change • Checkpoint inhibition • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    lerapolturev (PVS-RIPO)
    5ms
    Lerapolturev in Recurrent Malignant Glioma (clinicaltrials.gov)
    P2, N=121, Completed, Istari Oncology, Inc. | Active, not recruiting --> Completed
    Trial completion
    |
    lomustine • lerapolturev (PVS-RIPO)
    1year
    LUMINOS-103: A Basket Trial of Safety & Efficacy of Lerapolturev With or Without Checkpoint Inhibitors (clinicaltrials.gov)
    P1/2, N=4, Terminated, Istari Oncology, Inc. | N=15 --> 4 | Trial completion date: May 2025 --> Jun 2024 | Recruiting --> Terminated | Trial primary completion date: May 2025 --> Apr 2024; business decision
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Combination therapy • Checkpoint inhibition • Pan tumor • Metastases
    |
    lerapolturev (PVS-RIPO)
    1year
    LUMINOS-102: Lerapolturev With or Without Immune Checkpoint Blockade in Advanced PD-1 Refractory Melanoma (clinicaltrials.gov)
    P2, N=56, Active, not recruiting, Istari Oncology, Inc. | Trial primary completion date: Jun 2024 --> Oct 2024
    Trial primary completion date • Checkpoint inhibition • IO biomarker • Checkpoint block • Metastases
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • CD8 (cluster of differentiation 8)
    |
    PD-L1 expression • BRAF mutation • BRAF wild-type
    |
    lerapolturev (PVS-RIPO)
    1year
    LUMINOS-101: Lerapolturev (PVSRIPO) and Pembrolizumab in Patients with Recurrent Glioblastoma (clinicaltrials.gov)
    P2, N=25, Completed, Istari Oncology, Inc. | Active, not recruiting --> Completed | Trial completion date: Mar 2024 --> Jun 2024 | Trial primary completion date: Mar 2024 --> Jun 2024
    Trial completion • Trial completion date • Trial primary completion date • Checkpoint inhibition • IO biomarker
    |
    Keytruda (pembrolizumab) • lerapolturev (PVS-RIPO)
    1year
    PVSRIPO for Patients With Unresectable Melanoma (clinicaltrials.gov)
    P1, N=12, Terminated, Istari Oncology, Inc. | Completed --> Terminated; Study closed to enrollment due to business decision prior to enrolling Cohort 4
    Trial termination
    |
    BRAF (B-raf proto-oncogene) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CD4 (CD4 Molecule) • PVR (PVR Cell Adhesion Molecule)
    |
    BRAF mutation • BRAF wild-type • CD8 positive
    |
    lerapolturev (PVS-RIPO)
    over1year
    Lerapolturev (PVSRIPO) in GBM (clinicaltrials.gov)
    P2, N=92, Not yet recruiting, Darell Bigner | Initiation date: Apr 2024 --> Jul 2024
    Trial initiation date
    |
    lomustine • lerapolturev (PVS-RIPO)
    over1year
    Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children (clinicaltrials.gov)
    P1, N=8, Completed, Istari Oncology, Inc. | Active, not recruiting --> Completed | Phase classification: P1b --> P1 | N=12 --> 8
    Trial completion • Phase classification • Enrollment change
    |
    NF1 (Neurofibromin 1)
    |
    NF1 mutation
    |
    lerapolturev (PVS-RIPO)
    over1year
    LUMINOS-102: Lerapolturev With or Without Immune Checkpoint Blockade in Advanced PD-1 Refractory Melanoma (clinicaltrials.gov)
    P2, N=56, Active, not recruiting, Istari Oncology, Inc. | Trial completion date: Oct 2023 --> Oct 2024 | Trial primary completion date: Oct 2023 --> Jun 2024
    Trial completion date • Trial primary completion date • Checkpoint inhibition • IO biomarker • Checkpoint block • Metastases
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • CD8 (cluster of differentiation 8)
    |
    PD-L1 expression • BRAF mutation • BRAF wild-type
    |
    lerapolturev (PVS-RIPO)
    almost2years
    Lerapolturev (PVSRIPO) in GBM (clinicaltrials.gov)
    P2, N=92, Not yet recruiting, Darell Bigner | Initiation date: Dec 2023 --> Apr 2024
    Trial initiation date
    |
    lomustine • lerapolturev (PVS-RIPO)
    almost2years
    Examining Bioactivity of PVSRIPO in Invasive Breast Cancer (clinicaltrials.gov)
    P1, N=5, Completed, Istari Oncology, Inc. | Recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 amplification • HER-2 negative • HER-2 expression • ER expression • PGR expression
    |
    lerapolturev (PVS-RIPO)
    almost2years
    Lerapolturev (PVSRIPO) in GBM (clinicaltrials.gov)
    P2, N=92, Not yet recruiting, Darell Bigner
    New P2 trial
    |
    lomustine • lerapolturev (PVS-RIPO)