Biomarker-Driven Phase-2 Study of Combined Immune Checkpoint Blockade for AR-V7–Expressing Metastatic Castration-Resistant Prostate Cancer (STARVE-PC)
Johns Hopkins Kimmel Cancer Center in Baltimore
This a single arm Biomarker-Driven Phase-2 Study of Combined Immune Checkpoint Blockade for AR-V7–Expressing Metastatic Castration-Resistant Prostate Cancer. The main purpose of the study is to evaluate PSA responses ( greater than 50% PSA decline) in mCRPC patients with detectable AR-V7 transcript in CTCs
The main eligibility criteria for the study is 18 years old and older male with histologically or cytologically confirmed adenocarcinoma of the prostate and a positive AR-V7 test. The main exclusion criteria is previous therapy with investigational therapeutic drug, anti-androgens, external radiotherapy within 4 weeks prior to start of study treatment.
This is a single-arm, open-label phase II trial.Administration of ipilimumab + nivolumab will generally follow the treatment protocol used in the phase 3 trials of concurrent ipilimumab/nivolumab: concurrent administration every 3 weeks for fourDoses, followed by nivolumab alone every 2 weeks. The dosing regimen of nivolumab 3 mg/kg combined with ipilimumab 1 mg/kg was chosen because it exhibits similar clinical activity compared with nivolumab 1mg/kg combined with ipilimumab 3 mg/kg along with a more favorable safety profile.Treatment will continue until week 48 or until radiographic progression or unmanageable toxicity.
03/05/2019 05:03 AM