Ipilimumab
ipilimumab 10 mg/kg every 3 weeks for up to four doses.
placebo
placebo every 3 weeks for up to four doses.
patients received bone-directed radiotherapy (8 Gy in one fraction) followed by treatment. Non-progressing patients could continue to receive ipilimumab at 10 mg/kg or placebo as maintenance therapy. crossover or dose reduction was not permitted.
metastatic (mCRPC) - 1st line (L1)
Patients were excluded if they had received more than two cytotoxic chemotherapy regimens for castration-resistant prostate cancer
double blind
191 centres across 26 countries
p3/ two sided and no interim analysis. Hierarchical testing procedure with PFS
there was no significant difference between the ipilimumab group and the placebo group in terms of overall survival in the primary analysis
CA184-095, 2017 NCT01057810
ipilimumab alone (n=400) vs. placebo (n=202)
randomized controlled trial
ipilimumab
induction treatment with intravenous ipilimumab 10 mg/kg every 3 weeks for up to four doses (weeks 1, 4, 7, and 10) followed by double-blind maintenance treatment
placebo
induction treatment placebo (normal saline or 5% dextrose infused at a matching volume [2 mL/kg] and frequency) every 3 weeks for up to four doses (weeks 1, 4, 7, and 10) followed by double-blind maintenance treatment
induction treatment and maintenance. No re-induction with blinded study drug is allowed in this study. No subject crossover between treatment arms is allowed in this study.
metastatic (mCRPC) - 1st line (L1)
double blind
NA
P3/ two sided and one interim analysis. The secondary efficacy end points were tested in hierarchical order: PFS, time to subsequent nonhormonal cytotoxic therapy, time to pain progression
Ipilimumab did not improve OS in patients with metastatic castration-resistant prostate cancer.