Sipuleucel-T With Immediate vs. Delayed Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) Blockade for Prostate Cancer

Phase 2 Completed 50 enrolled University of California, San Francisco Bristol-Myers Squibb · collab Dendreon · collab M.D. Anderson Cancer Center · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to find out what effects taking ipilimumab, as an immediate or delayed treatment, following completion of sipuleucel-T (SipT) treatment, has on patients and their prostate cancer.

Timeline

Start: 2014-04-22
Primary completion: 2020-02-27
Completion: 2020-08-31

Outcome

Missed primary endpoint

paper The timing of ipilimumab did not significantly alter the rates of antigen-specific B and T cell responses, the primary endpoint of the clinical trial. PMID 33986125 ↗

Publications

Sinha M, Zhang L, Subudhi S, Chen B, Marquez J, Liu EV, Allaire K, Cheung A, Ng S, Nguyen C, Friedlander TW, Aggarwal R, Spitzer M, Allison JP, Small EJ, Sharma P, Fong L. Pre-existing immune status associated with response to combination of sipuleucel-T and ipilimumab in patients with metastatic castration-resistant prostate cancer. J Immunother Cancer. 2021 May;9(5):e002254. doi: 10.1136/jitc-2020-002254.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ipilimumab	Monoclonal antibody	—	Intravenous
Background	Sipuleucel-T	Cell therapy	—	—