- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Combination therapy, Checkpoint inhibition, Pan tumor, Metastases: LUMINOS-103: A Basket Trial of Safety & Efficacy of Lerapolturev With or Without Checkpoint Inhibitors (clinicaltrials.gov) - Oct 23, 2024
P1/2, N=4, Terminated,
N=15 --> 4 | Trial completion date: May 2025 --> Jun 2024 | Recruiting --> Terminated | Trial primary completion date: May 2025 --> Apr 2024; business decision
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Trial primary completion date, Checkpoint inhibition, IO biomarker, Checkpoint block, Metastases: LUMINOS-102: Lerapolturev With or Without Immune Checkpoint Blockade in Advanced PD-1 Refractory Melanoma (clinicaltrials.gov) - Oct 4, 2024
P2, N=56, Active, not recruiting,
N=15 --> 4 | Trial completion date: May 2025 --> Jun 2024 | Recruiting --> Terminated | Trial primary completion date: May 2025 --> Apr 2024; business decision Trial primary completion date: Jun 2024 --> Oct 2024
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Trial completion, Trial completion date, Trial primary completion date, Checkpoint inhibition, IO biomarker: LUMINOS-101: Lerapolturev (PVSRIPO) and Pembrolizumab in Patients with Recurrent Glioblastoma (clinicaltrials.gov) - Oct 1, 2024
P2, N=25, Completed,
Trial primary completion date: Jun 2024 --> Oct 2024 Active, not recruiting --> Completed | Trial completion date: Mar 2024 --> Jun 2024 | Trial primary completion date: Mar 2024 --> Jun 2024
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Trial termination: PVSRIPO for Patients With Unresectable Melanoma (clinicaltrials.gov) - Sep 19, 2024
P1, N=12, Terminated,
Updates on the formal trial proposed to enroll up to 86 patients will be provided. Completed --> Terminated; Study closed to enrollment due to business decision prior to enrolling Cohort 4
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Enrollment open: Lerapolturev (PVSRIPO) in GBM (clinicaltrials.gov) - Jul 18, 2024
P2, N=92, Recruiting,
Completed --> Terminated; Study closed to enrollment due to business decision prior to enrolling Cohort 4 Not yet recruiting --> Recruiting
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Trial initiation date: Lerapolturev (PVSRIPO) in GBM (clinicaltrials.gov) - Jun 2, 2024
P2, N=92, Not yet recruiting,
Not yet recruiting --> Recruiting Initiation date: Apr 2024 --> Jul 2024
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Trial completion, Phase classification, Enrollment change: Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children (clinicaltrials.gov) - Apr 7, 2024
P1, N=8, Completed,
Initiation date: Apr 2024 --> Jul 2024 Active, not recruiting --> Completed | Phase classification: P1b --> P1 | N=12 --> 8
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Trial completion date, Trial primary completion date, Checkpoint inhibition, IO biomarker, Checkpoint block, Metastases: LUMINOS-102: Lerapolturev With or Without Immune Checkpoint Blockade in Advanced PD-1 Refractory Melanoma (clinicaltrials.gov) - Apr 5, 2024
P2, N=56, Active, not recruiting,
Active, not recruiting --> Completed | Phase classification: P1b --> P1 | N=12 --> 8 Trial completion date: Oct 2023 --> Oct 2024 | Trial primary completion date: Oct 2023 --> Jun 2024
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Trial initiation date: Lerapolturev (PVSRIPO) in GBM (clinicaltrials.gov) - Feb 15, 2024
P2, N=92, Not yet recruiting,
Trial completion date: Oct 2023 --> Oct 2024 | Trial primary completion date: Oct 2023 --> Jun 2024 Initiation date: Dec 2023 --> Apr 2024
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
New P2 trial: Lerapolturev (PVSRIPO) in GBM (clinicaltrials.gov) - Dec 20, 2023
P2, N=92, Not yet recruiting,
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Trial completion date, Trial primary completion date: PVSRIPO in Recurrent Malignant Glioma (clinicaltrials.gov) - Sep 28, 2023
P2, N=122, Active, not recruiting,
Congruent with previous studies in the literature, the stereotactic placement of catheters in these pediatric tumor patients was accurate with approximately 95% of catheters having been adequately placed. Trial completion date: Dec 2023 --> Mar 2024 | Trial primary completion date: Aug 2023 --> Mar 2024
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Trial completion date, Trial primary completion date, Checkpoint inhibition, IO biomarker: LUMINOS-101: Lerapolturev (PVSRIPO) and Pembrolizumab in Patients with Recurrent Glioblastoma (clinicaltrials.gov) - Sep 28, 2023
P2, N=30, Active, not recruiting,
Trial completion date: Dec 2023 --> Mar 2024 | Trial primary completion date: Aug 2023 --> Mar 2024 Trial completion date: Mar 2023 --> Mar 2024 | Trial primary completion date: Mar 2023 --> Mar 2024
- |||||||||| Avastin (bevacizumab) / Roche, lerapolturev (PVS-RIPO) / Istari Oncology
P1 data, Clinical Trial,Phase I, Journal: Recombinant polio-rhinovirus immunotherapy for recurrent paediatric high-grade glioma: a phase 1b trial. (Pubmed Central) - Jun 26, 2023
P1b
Trial completion date: Mar 2023 --> Mar 2024 | Trial primary completion date: Mar 2023 --> Mar 2024 Convection enhanced delivery of lerapolturev is safe enough in the treatment of recurrent paediatric high-grade glioma to proceed to the next phase of trial.
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Trial completion date, Trial primary completion date, Checkpoint inhibition, IO biomarker, Checkpoint block, Metastases: LUMINOS-102: Lerapolturev With or Without Immune Checkpoint Blockade in Advanced PD-1 Refractory Melanoma (clinicaltrials.gov) - Dec 13, 2022
P2, N=56, Recruiting,
Convection enhanced delivery of lerapolturev is safe enough in the treatment of recurrent paediatric high-grade glioma to proceed to the next phase of trial. Trial completion date: May 2023 --> Oct 2023 | Trial primary completion date: Apr 2023 --> Oct 2023
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Identification, validation and biological characterization of novel Glioblastoma Tumour Microenvironment subtypes: Implications for precision immunotherapy (West/Central Hall) - Sep 28, 2022 - Abstract #SNO2022SNO_1176;
Moreover, TMEHigh patients treated with anti-PD1 and an oncolytic virus (PVSRIPO) in the adjuvant setting, showed a trend towards improved survival (P=0.15 and P=0.056 respectively)...This system may be used to better inform a precision targeting approach in the brain tumour setting. For example, we hypothesise that patients bearing TMELow tumours may be amenable to neoadjuvant anti-TIM3 + EGFR inhibitor, TMEMed to anti-angiogenic immunotherapy, and TMEHigh patients to neoadjuvant anti-PD1 + anti-CTLA4.
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Trial completion, Trial completion date: PVSRIPO for Recurrent Glioblastoma (GBM) (clinicaltrials.gov) - Jul 19, 2022
P1, N=61, Completed,
Histologic correlative results will also be presented. Active, not recruiting --> Completed | Trial completion date: Mar 2022 --> Oct 2021
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Enrollment open, Enrollment change, Combination therapy, Checkpoint inhibition, Pan tumor, Metastases: LUMINOS-103: A Basket Trial of Safety & Efficacy of Lerapolturev With or Without Checkpoint Inhibitors (clinicaltrials.gov) - Jul 11, 2022
P1/2, N=15, Recruiting,
Active, not recruiting --> Completed | Trial completion date: Mar 2022 --> Oct 2021 Active, not recruiting --> Recruiting | N=155 --> 15
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Trial completion, Enrollment change: PVSRIPO for Patients With Unresectable Melanoma (clinicaltrials.gov) - Jun 30, 2022
P1, N=12, Completed,
Active, not recruiting --> Recruiting | N=155 --> 15 Active, not recruiting --> Completed | N=18 --> 12
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Enrollment open, Checkpoint inhibition, IO biomarker, Checkpoint block, Metastases: LUMINOS-102: Lerapolturev With or Without Immune Checkpoint Blockade in Advanced PD-1 Refractory Melanoma (clinicaltrials.gov) - Jun 1, 2022
P2, N=56, Recruiting,
Active, not recruiting --> Completed | N=18 --> 12 Active, not recruiting --> Recruiting
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Enrollment closed, Combination therapy, Checkpoint inhibition, Pan tumor, Metastases: LUMINOS-103: A Basket Trial of Safety & Efficacy of Lerapolturev With or Without Checkpoint Inhibitors (clinicaltrials.gov) - Apr 27, 2022
P1/2, N=155, Active, not recruiting,
Active, not recruiting --> Recruiting Recruiting --> Active, not recruiting
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Enrollment closed, Checkpoint inhibition, IO biomarker, Checkpoint block, Metastases: LUMINOS-102: Lerapolturev With or Without Immune Checkpoint Blockade in Advanced PD-1 Refractory Melanoma (clinicaltrials.gov) - Apr 4, 2022
P2, N=56, Active, not recruiting,
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Trial completion date: PVSRIPO for Recurrent Glioblastoma (GBM) (clinicaltrials.gov) - Jan 31, 2022
P1, N=61, Active, not recruiting,
Recruiting --> Active, not recruiting Trial completion date: Dec 2021 --> Mar 2022
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Trial completion date, Trial primary completion date: PVSRIPO for Patients With Unresectable Melanoma (clinicaltrials.gov) - Jan 26, 2022
P1, N=18, Active, not recruiting,
Trial completion date: Dec 2021 --> Mar 2022 Trial completion date: Dec 2021 --> Apr 2022 | Trial primary completion date: Dec 2021 --> Mar 2022
- |||||||||| PVS-RIPO / Istari Oncology
Clinical, P1 data, Journal, PD(L)-1 Biomarker, IO biomarker: Phase I trial of intratumoral PVSRIPO in patients with unresectable, treatment-refractory melanoma. (Pubmed Central) - Dec 21, 2021
P1
Intratumoral PVSRIPO was well tolerated. Despite the limited number of PVSRIPO treatments relative to the overall lesion burden (67% patients>5 lesions), intratumoral PVSRIPO showed promising antitumor activity, with pCR in injected as well as non-injected lesions in select patients.
- |||||||||| PVS-RIPO / Istari Oncology
Polio virotherapy of murine brain tumors induces microglia proliferation and inflammation that is potentiated by immune checkpoint blockade (Room 208) - Nov 16, 2021 - Abstract #SNO2021SNO_1171;
Immunotherapy with polio:rhinovirus recombinant (PVSRIPO) has shown evidence of efficacy in a phase I clinical trial for recurrent GBM, resulting in durable radiographic responses and 21% long-term survival at 36 months...Thus, buttressing type-I IFN directed antitumor CD8+T cell immunity, e.g. with blockade of the PD1:PD-L1 immune checkpoint, might contribute to tumor remission. Indeed, combination therapy with αPD-L1 antibody in the CT2A model showed longer median survival and higher long-term remission rate compared to monotherapy alone; CD8 T cell depletion can completely abrogate this efficacy with this therapy combination, confirming the role of anti-tumor immunity in this approach.
- |||||||||| PVS-RIPO / Istari Oncology
Tumor-intrinsic and peripheral features associate with survival after polio virotherapy in recurrent GBM (Exhibit Hall D) - Nov 16, 2021 - Abstract #SNO2021SNO_252;
BACKGROUND PVSRIPO is a live-attenuated recombinant rhino:poliovirus that mediates antitumor efficacy by engaging antitumor immunity...Low TMB in rGBM tumors was also associated with neoantigen depletion. Collectively, these observations imply that patients with low TMB and/or shorter duration of standard of care therapy may have intact immune surveillance, and that pre-treatment immunological status may dictate survival response to polio virotherapy.
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Enrollment closed, Checkpoint inhibition, IO biomarker: LUMINOS-101: Lerapolturev (PVSRIPO) and Pembrolizumab in Patients with Recurrent Glioblastoma (clinicaltrials.gov) - Nov 4, 2021
P2, N=30, Active, not recruiting,
Relative to published data with approved therapies, PVSRIPO was associated with greater long-term survival and mOS in patients with rGBM and was generally well-tolerated. Recruiting --> Active, not recruiting
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Trial completion date: PVSRIPO for Recurrent Glioblastoma (GBM) (clinicaltrials.gov) - Oct 25, 2021
P1, N=61, Active, not recruiting,
Recruiting --> Active, not recruiting Trial completion date: Jun 2021 --> Dec 2021
- |||||||||| PVS-RIPO / Istari Oncology
Intratumor childhood vaccine-specific CD4+ T cell recall helps antitumor CD8 T cells (Poster Hall) - Oct 1, 2021 - Abstract #SITC2021SITC_553;
P2
Conclusions Childhood vaccine-specific CD4+ T cells hold cancer immunotherapy potential. In the context of PVSRIPO therapy, antitumor and inflammatory effects of polio vaccine-specific CD4+ T cell recall supersedes inhibitory effects of attenuated intratumor viral replication, and represents a novel mechanism of action.
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Trial completion date, Trial primary completion date, Oncolytic virus: Examining Bioactivity of PVSRIPO in Invasive Breast Cancer (clinicaltrials.gov) - Aug 18, 2021
P1, N=6, Recruiting,
Trial Registration ClinicalTrials.gov: NCT04690699 Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Jul 2021 --> Jul 2022
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Trial primary completion date: Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children (clinicaltrials.gov) - Jul 13, 2021
P1b, N=12, Active, not recruiting,
Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Jul 2021 --> Jul 2022 Trial primary completion date: Jun 2021 --> Dec 2021
- |||||||||| PVS-RIPO / Istari Oncology
[VIRTUAL] Istari Oncology () - May 31, 2021 - Abstract #BIO2021BIO_394;
We believe PVSRIPO to be the “best in class” intratumoral therapy and ideal combination partner for PD-1/L1 inhibitors, thanks to its ability to activate innate and adaptive immunity to facilitate a systemic, polyfunctional antitumor CD8+ T cell response. Istari’s robust and expanding clinical trial program is investigating PVSRIPO in combination with PD-1/L1 inhibitors across a range of solid tumors at many of the leading cancer institutions in the US.
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Trial primary completion date: Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children (clinicaltrials.gov) - Mar 25, 2021
P1b, N=12, Recruiting,
Recruitment is ongoing in the US, and results will inform the design of a randomized phase 3 trial. Trial primary completion date: Mar 2021 --> Jun 2021
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