- |||||||||| PVS-RIPO / Istari Oncology
Clinical, Journal, IO biomarker: Persistent STAG2 mutation despite multimodal therapy in recurrent pediatric glioblastoma. (Pubmed Central) - Feb 15, 2021
This report describes the genetic findings, obtained from whole-exome sequencing of a pediatric patient with glioblastoma who underwent multiple surgical resections and treatment with standard chemoradiation, as well as a novel recombinant poliovirus vaccine therapy...As such, this case represents a novel report following the clinical and genetic progression of a STAG2 mutated glioblastoma, including treatment with a novel and emerging immunotherapy. Although STAG2 deficiency comprises only a small subset of gliomas, this case adds clinical evidence to existing preclinical data supporting a role for STAG2 mutations in gliomagenesis and resistance to standard therapies.
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Enrollment closed, Trial completion date, Trial primary completion date: PVSRIPO for Patients With Unresectable Melanoma (clinicaltrials.gov) - Jan 14, 2021
P1, N=18, Active, not recruiting,
Although STAG2 deficiency comprises only a small subset of gliomas, this case adds clinical evidence to existing preclinical data supporting a role for STAG2 mutations in gliomagenesis and resistance to standard therapies. Recruiting --> Active, not recruiting | Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Dec 2020 --> Dec 2021
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Trial completion date, Trial primary completion date: Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children (clinicaltrials.gov) - Dec 28, 2020
P1b, N=12, Recruiting,
Recruiting --> Active, not recruiting | Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Dec 2020 --> Dec 2021 Trial completion date: Jul 2021 --> Mar 2022 | Trial primary completion date: Jul 2020 --> Mar 2021
- |||||||||| nanocrystalline form of fluticasone (AC-155) / Nicox, PVS-RIPO / Istari Oncology
[VIRTUAL] Oncolytic poliovirus as a probe for mechanisms of immune resistance in glioblastoma () - Oct 24, 2020 - Abstract #SNO2020SNO_829;
This model is valuable in studying the mechanisms of intrinsic resistance and the timeline of resistance to develop in order to obtain more durable immunotherapy responses in glioblastoma. Future steps are to track inflammation induced by viral infection by RNAseq, and to find potential therapeutic interventions (including blocking PD1:PD-L1 axis) to mitigate therapy resistance in this preclinical model.
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Enrollment open, Checkpoint inhibition, IO biomarker: LUMINOS-101: Lerapolturev (PVSRIPO) and Pembrolizumab in Patients with Recurrent Glioblastoma (clinicaltrials.gov) - Oct 22, 2020
P1, N=10, Recruiting,
Future steps are to track inflammation induced by viral infection by RNAseq, and to find potential therapeutic interventions (including blocking PD1:PD-L1 axis) to mitigate therapy resistance in this preclinical model. Not yet recruiting --> Recruiting
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Enrollment open: PVSRIPO for Patients With Unresectable Melanoma (clinicaltrials.gov) - Sep 11, 2020
P1, N=12, Recruiting,
Ethics Approval This study (NCT03712358) was approved by WIRB; ID 20181772. Active, not recruiting --> Recruiting
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Enrollment closed: PVSRIPO in Recurrent Malignant Glioma (clinicaltrials.gov) - Jun 18, 2020
P2, N=122, Active, not recruiting,
Active, not recruiting --> Recruiting Recruiting --> Active, not recruiting
- |||||||||| PVS-RIPO / Istari Oncology
Oncolytic poliovirus immunotherapy for breast cancer (Board Number: P1366) - Apr 25, 2020 - Abstract #IMMUNOLOGY2020IMMUNOLOGY_1844;
We observed that intratumor PVSRIPO followed by surgery effectively controls tumor growth and prevents tumor regrowth following tumor rechallenge, suggesting induction of a systemic immune response. We are now testing neoadjuvant PVSRIPO with anti-PD1/-PDL1 in murine models of cancer.
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Enrollment closed: PVSRIPO for Patients With Unresectable Melanoma (clinicaltrials.gov) - Apr 7, 2020
P1, N=12, Active, not recruiting,
We are now testing neoadjuvant PVSRIPO with anti-PD1/-PDL1 in murine models of cancer. Recruiting --> Active, not recruiting
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Trial completion date, Trial primary completion date: PVSRIPO in Recurrent Malignant Glioma (clinicaltrials.gov) - Mar 12, 2020
P2, N=122, Recruiting,
Recruiting --> Active, not recruiting Trial completion date: May 2023 --> Dec 2023 | Trial primary completion date: May 2021 --> Aug 2023
- |||||||||| PVS-RIPO / Istari Oncology
Journal: Genetically stable poliovirus vectors activate dendritic cells and prime antitumor CD8 T cell immunity. (Pubmed Central) - Feb 14, 2020
PVSRIPO vectors infect, activate, and induce epitope presentation in DCs in vitro; they recruit and activate DCs with Th1-dominant cytokine profiles at the injection site in vivo. They efficiently prime tumor antigen-specific CD8 T cells in vivo, induce CD8 T cell migration to the tumor site, delay tumor growth and enhance survival in murine tumor models.
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology, Tecentriq (atezolizumab) / Roche
Enrollment change, Trial withdrawal, Combination therapy: Combination of PVSRIPO and Atezolizumab for Adults With Recurrent Malignant Glioma (clinicaltrials.gov) - Jan 30, 2020
P1b/2, N=0, Withdrawn,
They efficiently prime tumor antigen-specific CD8 T cells in vivo, induce CD8 T cell migration to the tumor site, delay tumor growth and enhance survival in murine tumor models. N=31 --> 0 | Not yet recruiting --> Withdrawn
- |||||||||| Opdivo (nivolumab) / BMS, lerapolturev (PVS-RIPO) / Istari Oncology
Enrollment change, Trial withdrawal: PVSRIPO in Combination With Nivolumab in Melanoma (clinicaltrials.gov) - Jan 27, 2020
P1, N=0, Withdrawn,
N=31 --> 0 | Not yet recruiting --> Withdrawn N=30 --> 0 | Not yet recruiting --> Withdrawn
- |||||||||| Opdivo (nivolumab) / BMS, lerapolturev (PVS-RIPO) / Istari Oncology
Trial initiation date: PVSRIPO in Combination With Nivolumab in Melanoma (clinicaltrials.gov) - Dec 19, 2019
P1, N=30, Not yet recruiting,
N=30 --> 0 | Not yet recruiting --> Withdrawn Initiation date: Dec 2019 --> Jun 2020
- |||||||||| PVS-RIPO / Istari Oncology
Genetically Stable Poliovirus Vector Platform for DIPG Immunotherapy (Ballroom Lawn) - Oct 29, 2019 - Abstract #SNO2019SNO_1071;
They efficiently prime tumor antigen-specific CD8 T cells in vivo,induce CD8 T cell migration to the tumor site, delay tumor growth and enhance survival in syngeneic rodent tumor models. We are preparing a prototype PVSRIPO-derived vector delivering the H3.3(K27M) signature for clinical investigation.
- |||||||||| PVS-RIPO / Istari Oncology
ATRX mutations predict response to innate based therapy in glioma. (Wildflower A) - Oct 29, 2019 - Abstract #SNO2019SNO_897;
CONCLUSION Our data suggests that ATRX mutations may confer sensitivity to RNA-based innate immune signaling agonists in gliomas. This potential vulnerability can be targeted in future therapies.
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology, Tecentriq (atezolizumab) / Roche
Trial completion date, Trial initiation date, Trial primary completion date, Combination therapy: Combination of PVSRIPO and Atezolizumab for Adults With Recurrent Malignant Glioma (clinicaltrials.gov) - Oct 21, 2019
P1b/2, N=31, Not yet recruiting,
This potential vulnerability can be targeted in future therapies. Trial completion date: Sep 2023 --> Jan 2024 | Initiation date: Oct 2019 --> Feb 2020 | Trial primary completion date: Sep 2023 --> Jan 2024
- |||||||||| PVS-RIPO / Istari Oncology
Journal: Recombinant Poliovirus for Cancer Immunotherapy. (Pubmed Central) - Sep 18, 2019
In this review, we explain the mechanisms of recombinant nonpathogenic poliovirus, PVSRIPO, which is currently in phase I clinical trials against recurrent glioblastoma. We focus on an unusual host:virus relationship defined by the simple and cytotoxic replication strategy of poliovirus, which generates inflammatory perturbations conducive to tumor antigen-specific immune priming.
- |||||||||| paclitaxel / Generic Mfg.
Clinical, Review, Journal: Convection-Enhanced Delivery in Malignant Gliomas: A Review of Toxicity and Efficacy. (Pubmed Central) - Aug 22, 2019
With this treatment, patients who received CED of the chemotherapeutic agent paclitaxel and immunomodulator, oligodeoxynucleotides containing CpG motifs (CpG-ODN), experienced intolerable toxicity. Toward the end of this article, an ideal CED treatment procedure is proposed and the methods for quality assurance of the CED procedure are discussed.
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Enrollment change, Combination therapy: PVSRIPO in Recurrent Malignant Glioma (clinicaltrials.gov) - Jan 11, 2019
P2, N=102, Recruiting,
Toward the end of this article, an ideal CED treatment procedure is proposed and the methods for quality assurance of the CED procedure are discussed. N=62 --> 102
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Enrollment open: PVSRIPO for Patients With Unresectable Melanoma (clinicaltrials.gov) - Nov 28, 2018
P1, N=9, Recruiting,
Initiation date: Nov 2018 --> Feb 2019 Not yet recruiting --> Recruiting
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Trial completion date: PVSRIPO for Recurrent Glioblastoma (GBM) (clinicaltrials.gov) - Mar 3, 2018
P1, N=61, Active, not recruiting,
Not yet recruiting --> Recruiting Trial completion date: Jan 2018 --> Dec 2018
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Trial primary completion date: PVSRIPO for Recurrent Glioblastoma (GBM) (clinicaltrials.gov) - Sep 12, 2017
P1, N=61, Active, not recruiting,
Not yet recruiting --> Recruiting Trial primary completion date: Oct 2017 --> Jun 2017
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Trial initiation date, Trial primary completion date: PVSRIPO for Recurrent Glioblastoma (GBM) (clinicaltrials.gov) - Aug 3, 2017
P1, N=61, Active, not recruiting,
Trial primary completion date: Oct 2017 --> Jun 2017 Initiation date: Jan 2012 --> Apr 2012 | Trial primary completion date: Jun 2017 --> Oct 2017
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Enrollment closed: PVSRIPO for Recurrent Glioblastoma (GBM) (clinicaltrials.gov) - Jun 14, 2017
P1, N=61, Active, not recruiting,
Initiation date: Jan 2012 --> Apr 2012 | Trial primary completion date: Jun 2017 --> Oct 2017 Recruiting --> Active, not recruiting
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Enrollment open, Combination therapy: PVSRIPO in Recurrent Malignant Glioma (clinicaltrials.gov) - Jun 5, 2017
P2, N=62, Recruiting,
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- |||||||||| lerapolturev (PVS-RIPO) / Istari Oncology
Trial primary completion date: PVSRIPO for Recurrent Glioblastoma (GBM) (clinicaltrials.gov) - Feb 27, 2017
P1, N=65, Recruiting,
Not yet recruiting --> Recruiting Trial primary completion date: Jan 2017 --> Jul 2017
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