Spots Global Cancer Trial Database for Ipilimumab With Nivolumab for Molecular-selected Patients With Castration-resistant Prostate Cancer

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Trial Identification

Brief Title: Ipilimumab With Nivolumab for Molecular-selected Patients With Castration-resistant Prostate Cancer

Official Title: Phase 2 INSPIRE Trial: Ipilimumab With Nivolumab for Molecular- Selected Patients With Castration-resistant Prostate Cancer

Study ID: NCT04717154

Conditions

Prostatic Neoplasms, Castration-Resistant

Interventions

Ipilimumab

Nivolumab

Study Description

Brief Summary: The purpose of this study is to evaluate the effects of 4 cycles of combinatory immunotherapy (ipilimumab and nivolumab), followed by monotherapy nivolumab in participants with immunogenic metastatic castration-resistant prostate cancer.

Detailed Description: Following molecular characterization (next-generation sequencing) a total of 75 mCRPC patients with a putative immunogenic subtype will be included within the phase 2 INSPIRE trial. As treatment we will be utilizing a combinatory regimen of nivolumab 3mg/kg and ipilimumab 1mg/kg for 4 doses, followed by nivolumab 480mg flat dose for up to one year. All participants will additionally undergo an on-trial metastatic tissue biopsy. Translational research will study immunological correlates and in-depth genomic/transcriptomic and multispectral immunohistochemical analyses of immune infiltrate.