Current Prostate Cancer clinical trials being conducted at TACRI
Parker Institute Protocol PICI0033
A multicenter, open-label, exploratory platform study to evaluate biomarkers and immunotherapy combinations for the treatment of patients with metastatic castration resistant prostate cancer.
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).
Condition/Disease: Metastatic Castration-resistant Prostate Cancer.
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).
Intervention/Treatment:
Drug: NKTR-214 (Cohort A)
Drug: Nivolumab (Cohort A, B and C)
Radiation: Stereotactic body radiation therapy (SBRT) (Cohort B)
Drug: CDX-301 (Cohort B and C)
Drug: Poly-ICLC (Cohort B)
Drug: INO-5151 (Cohort C)
Device: Cellectra 2000
Phase 1. Detailed 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.