NCT02601014

Biomarker-Driven Therapy With Nivolumab and Ipilimumab in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Expressing AR-V7

Biomarker-Driven Phase-2 Study of Combined Immune Checkpoint Blockade for AR-V7-Expressing Metastatic Castration-Resistant Prostate Cancer (STARVE-PC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well nivolumab and ipilimumab work in treating patients with hormone-resistant prostate cancer that has spread to other places in the body and express androgen receptor-variant-7 (AR-V7). Tumor cells expressing AR-V7 has been shown to be resistant to hormone therapy and some chemotherapy in patients with prostate cancer. Biomarker-driven therapy, such as nivolumab and ipilimumab, may work by blocking key biomarkers or proteins that help tumor cells to escape the immune system surveillance and this may help the immune system to kill tumor cells that express AR-V7.

Conditions

• Prostate Cancer
• Recurrent Prostate Carcinoma
• Stage IV Prostate Adenocarcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Ipilimumab	Given 1 mg/kg IV
BIOLOGICAL	Nivolumab	Given 3 mg/kg IV
DRUG	Enzalutamide	given orally per standard of care

Timeline

• Start date: 2016-03-15
• Primary completion: 2020-12-03
• Completion: 2021-10-06
• First posted: 2015-11-10
• Last updated: 2022-02-03
• Results posted: 2022-02-03

Locations

1 site across 1 country: United States