ESK981 and Nivolumab for the Treatment of Metastatic Castration Resistant Prostate Cancer
Summary
This phase II trial studies the side effects of ESK981 and nivolumab and to see how well they work for the treatment of castration resistant prostate cancer that has spread to other places in the body (metastatic). ESK981 is an investigational drug that targets several important pathways that are believed to play a role in the spread of cancer. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This study is being done to see if giving ESK981 and nivolumab together works better in treating metastatic castration resistant prostate cancer compared to usual treatments.
Timeline
- Start
- 2019-11-13
- Primary completion
- 2022-03-01
- Completion
- 2022-03-01
Outcome
Missed primary endpoint
Stopped (Enrollment): “The study was closed to accrual on 3/1/21 due to safety concerns since 2 patients experienced CVA events.”
paper The maximum PSA decline from baseline of 14% was achieved in only one patient. PMID 39503807 ↗