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- || Biomarker, Trial completion, Trial primary completion date, IO biomarker, Metastases: PORTER: Platform Study for Prostate Researching Translational Endpoints Correlated to Response to Inform Use of Novel Combinations (clinicaltrials.gov) - Nov 14, 2022
P1, N=43, Completed, Sponsor: Parker Institute for Cancer Immunotherapy
Active, not recruiting --> Completed | Trial primary completion date: May 2022 --> Oct 2022
- Opdivo (nivolumab) / Ono Pharma, BMS
Biomarker Correlates of Clinical Response with FLT3L/Nivo Backbone Treatment in the Multi-Cohort Phase 1 PORTER Platform Trial in Metastatic Castration-Resistant Prostate Cancer Patients (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_890;
Cohort C included INO-5151, DNA vaccine expressing PSA/PSMA/IL-12 DNA plasmids...Further work to integrate these findings with tumor imaging and genomic data is ongoing. Overall, the joint analysis of the two cohorts involving FLT3L + nivolumab highlights the power of a platform study to rapidly identify common biomarkers of clinical response and/or resistance and simultaneously interrogate treatment effects of cancer-specific immunotherapy combinations.
- Clinical and Pharmacodynamic Biomarker Results from PORTER, a multi-cohort Phase 1 Platform Trial of Combination Immunotherapy for Metastatic Castration-Resistant Prostate Cancer Patients (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_887;
Conclusions This platform study design demonstrated the feasibility and efficiency of iteratively testing distinct immunotherapy combinations with comprehensive biomarker assessment in patients with mCRPC. While neither cohort A nor C were expanded due to insufficient clinical activity, the clinical responses seen with SBRT/FLT3L/polyICLC/nivolumab suggest sufficient clinical benefit that may warrant additional investigation, particularly the contribution of radiation to the responses observed.
- || Biomarker, Enrollment closed, Trial completion date, IO biomarker, Metastases: PORTER: Platform Study for Prostate Researching Translational Endpoints Correlated to Response to Inform Use of Novel Combinations (clinicaltrials.gov) - Sep 28, 2022
P1, N=45, Active, not recruiting, Sponsor: Parker Institute for Cancer Immunotherapy
While neither cohort A nor C were expanded due to insufficient clinical activity, the clinical responses seen with SBRT/FLT3L/polyICLC/nivolumab suggest sufficient clinical benefit that may warrant additional investigation, particularly the contribution of radiation to the responses observed. Recruiting --> Active, not recruiting | Trial completion date: Mar 2023 --> Oct 2022
- | Biomarker, Trial primary completion date, IO biomarker, Metastases: PORTER: Platform Study for Prostate Researching Translational Endpoints Correlated to Response to Inform Use of Novel Combinations (clinicaltrials.gov) - Jun 9, 2022
P1, N=45, Recruiting, Sponsor: Parker Institute for Cancer Immunotherapy
Recruiting --> Active, not recruiting | Trial completion date: Mar 2023 --> Oct 2022 Trial primary completion date: Mar 2022 --> May 2022
- | Biomarker, Enrollment change, IO biomarker, Metastases: PORTER: Platform Study for Prostate Researching Translational Endpoints Correlated to Response to Inform Use of Novel Combinations (clinicaltrials.gov) - Jul 17, 2019
P1, N=45, Recruiting, Sponsor: Parker Institute for Cancer Immunotherapy
Trial primary completion date: Mar 2022 --> May 2022 N=30 --> 45
- | Biomarker, Enrollment open, IO biomarker, Metastases: PORTER: Platform Study for Prostate Researching Translational Endpoints Correlated to Response to Inform Use of Novel Combinations (clinicaltrials.gov) - Jul 11, 2019
P1, N=30, Recruiting, Sponsor: Parker Institute for Cancer Immunotherapy
N=30 --> 45 Not yet recruiting --> Recruiting
- || Biomarker, Trial initiation date, IO biomarker, Metastases: PORTER: Platform Study for Prostate Researching Translational Endpoints Correlated to Response to Inform Use of Novel Combinations (clinicaltrials.gov) - Jun 13, 2019
P1, N=30, Not yet recruiting, Sponsor: Parker Institute for Cancer Immunotherapy
Not yet recruiting --> Recruiting Initiation date: Mar 2019 --> Jun 2019
- || Biomarker, New P1 trial, IO biomarker, Metastases: PORTER: Platform Study for Prostate Researching Translational Endpoints Correlated to Response to Inform Use of Novel Combinations (clinicaltrials.gov) - Feb 8, 2019
P1, N=30, Not yet recruiting, Sponsor: Parker Institute for Cancer Immunotherapy