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Platform Study for Prostate Researching Translational Endpoints Correlated to Response to Inform Use of Novel Combinations — PORTER  

Metastatic Castration-resistant Prostate Cancer Clinical Trial

Official title:
A Multicenter, Open-Label, Exploratory Platform Study to Evaluate Biomarkers and Immunotherapy Combinations for the Treatment of Patients With Metastatic Castration-resistant Prostate Cancer

Clinical Trial Summary

This study is designed to evaluate multiple clinical hypotheses and mechanistically-defined combinations to evaluate the safety and efficacy of immunotherapy combinations in participants with mCRPC who have received prior secondary androgen receptor signaling inhibitor therapy (eg, abiraterone, enzalutamide, apalutamide).

Clinical Trial Description

This is an open-label, non-randomized, exploratory platform protocol designed to assess the safety and antitumor activity of multiple immunotherapy combinations in participants with mCRPC who have received prior therapy. The platform study will consist of 2 stages: Stage 1, an initial stage to evaluate safety, biomarkers, and clinical activity of a combination and Stage 2, an expanded cohort, when warranted, based on the safety, clinical activity, and/or biomarker results from Stage 1. The Sponsor intends to modify and/or add new combinations to the protocol as data emerge from this and other trials. Participants must provide consent for archival tissue from a prior biopsy or surgery for prostate cancer and must consent to baseline and on-treatment biopsies, if medically feasible. Participants will be assigned to receive one of the enrolling combination study interventions and will be monitored for safety and response. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03835533
Study type Interventional
Source Parker Institute for Cancer Immunotherapy
Contact
Status Completed
Phase Phase 1
Start date June 21, 2019
Completion date October 3, 2022
View Details
See also
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