ipilimumab plus SoC (n=566) vs. placebo plus SoC (n=566)
randomized controlled trial
Ipilimumab plus etoposide plus platine
ipilimumab 10 mg/kg intravenously (IV) (3-week cycles and then 12 week cycles for maintenance) plus etoposide 100 mg/m2 IV on days 1, 2, and 3 of each cycle and investigator’s choice of platinum agent on day 1 of each cycle (cisplatin 75 mg/m2 IV or carboplatin area under the concentration-time curve 5 IV) during cycles one to four of induction
Placebo plus etoposide plus platine
placebo (3-week cycles), etoposide 100 mg/m2 IV on days 1, 2, and 3 of each cycle and investigator’s choice of platinum agent on day 1 of each cycle (cisplatin 75 mg/m2 IV or carboplatin area under the concentration-time curve 5 IV) during cycles one to four of induction
No dose reductions were permitted for ipilimumab or placebo
Extensive stage SCLC (Es-SCLC) - 1st Line (L1)
double-blind
224 study sites in 34 countries,
P3 / two-sided test procedure with no formal interim analysis. Secondary efficacy endpoints will be tested in the following hierarchical order: OS in the population of all randomized subjects followed by PFS per mWHO among randomized subjects who received at least one dose of blinded study therapy. study with randomization at the beginning of the induction period is inappropriate to evaluate only maintenance interest.
Addition of ipilimumab to chemotherapy did not prolong OS versus chemotherapy alone in patients with newly diagnosed extensive-stage disease SCLC.