Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.

BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. All BSC = Active and non-active BSC.

Significance level used: 0.2

The hazard ratio and its associated two-sided 80% confidence interval (CI) was estimated via a stratified Cox model with treatment arm as the only covariate in the model

Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.

BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. All BSC = Active and non-active BSC.

Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.

BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. All BSC = Active and non-active BSC.

Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.

BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. All BSC = Active and non-active BSC.

Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.