A Study of Nivolumab in Participants With Metastatic or Unresectable Bladder Cancer

DOR is defined as the time from first confirmed response, complete response (CR) or partial response (PR) to the date of the first documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Participants who start subsequent therapy without a prior reported progression will be censored at the last evaluable tumor assessments prior to initiation of the subsequent anticancer therapy. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment.

Time frame: From the first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurs first (up to approximately 14 months)

Population: All responders-includes responders who had neither progressed nor initiated subsequent therapy at the time of analysis, and excludes responders censored prior to 12 weeks of the clinical data cutoff date (if this cutoff date is before week 48) or prior to 18 weeks of the clinical data cutoff date (if this cutoff date is after or on week 48)

Objective Response Rate (ORR) was defined as the number of participants with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) (per RECIST 1.1 criteria) divided by the number of all treated participants. RECIST 1.1 = Response Evaluation Criteria in Solid Tumors. CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. BIRC= blinded independent review committee

Time frame: From the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (assessed up to 14 months)

Population: All treated participants. Treated participants from Japan enrolled after main enrollment period were excluded from primary efficacy analysis.

Objective Response Rate (ORR) was defined as the number of participants with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) (per RECIST 1.1 criteria) divided by the number of all treated participants. RECIST 1.1 = Response Evaluation Criteria in Solid Tumors. CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. BIRC= blinded independent review committee PD-L1 expression level= membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells. n = Number of participants in each category

Time frame: From the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (assessed up to 14 months)

Population: All treated participants. Treated participants from Japan enrolled after main enrollment period were excluded from primary efficacy analysis.

TTR is defined as the time from first dosing date to the date of the first confirmed complete response (CR) or partial response (PR), as assessed by the Blinded Independent Review Committee (BIRC). Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Time frame: From first dosing date to the date of the first confirmed response (up to approximately 14 months)

Population: All responders-includes responders who had neither progressed nor initiated subsequent therapy at the time of analysis, and excludes responders censored prior to 12 weeks of the clinical data cutoff date (if this cutoff date is before week 48) or prior to 18 weeks of the clinical data cutoff date (if this cutoff date is after or on week 48)

Investigator-assessed ORR was defined as the percent of participants with a best overall response of confirmed complete response (CR) or partial response (PR). Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD-L1 expression level = Membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells.

Time frame: From the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (up to approximately 45 months)

Population: All treated participants

Overall Survival was defined as the time from first dosing date to the date of death. A participant who had not died was censored at last known date alive. PD-L1 expression level = membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells.

Time frame: From first dosing date to the date of death (up to approximately 23 months)

Population: All treated participants

PFS was defined as the time from first dosing date to the date of the first documented tumor progression, based on Blinded Independent Review Committee (BIRC) assessments or death due to any cause. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. PD-L1 expression level is defined as membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells.

Time frame: From first dosing date to the date of the first documented tumor progression (up to approximately 6 months)

Population: All treated participants

DOR is the time from first confirmed response, complete (CR) or partial response (PR) to the date of the first tumor progression PER RECIST 1.1 criteria or death due to any cause, whichever occurs first. Participants without prior reported progression will be censored at the last evaluable tumor assessments prior to subsequent anticancer therapy. Participants who die without a reported prior progression will be considered on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions. Note: This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date.

Time frame: From the first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurs first (up to approximately 32 months)

Population: All responders-includes responders who had neither progressed nor initiated subsequent therapy at the time of analysis, and excludes responders censored prior to 12 weeks of the clinical data cutoff date (if this cutoff date is before week 48) or prior to 18 weeks of the clinical data cutoff date (if this cutoff date is after or on week 48)

Objective Response Rate (ORR) was defined as the percent of participants with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) (per RECIST 1.1 criteria). RECIST 1.1 = Response Evaluation Criteria in Solid Tumors. CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. BIRC= blinded independent review committee PD-L1 expression level= membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells. Note: This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date.

Time frame: From the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (up approximately to 43 months)

Population: All treated participants

TTR is defined as the time from first dosing date to the date of the first confirmed complete response (CR) or partial response (PR), as assessed by the Blinded Independent Review Committee (BIRC). Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Note: This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date.

Time frame: From first dosing date to the date of the first confirmed response (up to approximately 14 months)

Population: All responders-includes responders who had neither progressed nor initiated subsequent therapy at the time of analysis, and excludes responders censored prior to 12 weeks of the clinical data cutoff date (if this cutoff date is before week 48) or prior to 18 weeks of the clinical data cutoff date (if this cutoff date is after or on week 48)