First-Line Nivolumab Plus Ipilimumab in Unresectable Hepatocellular Carcinoma (J-PROMISE)

Number of participants who experience grade 3-5 immune-mediated liver injury (IMLI), defined as treatment-related hepatic adverse events assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Time from first dose of nivolumab plus ipilimumab to first occurrence of immune-mediated liver injury (any grade).

Time from onset of immune-mediated liver injury to resolution, defined as recovery, recovery with sequelae, or improvement per clinician assessment.

Number of participants with complete response (CR) or partial response (PR) as best overall response among participants with baseline target lesions, assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Distribution of best overall response categorized as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or not evaluable (NE) among participants with baseline target lesions per RECIST v1.1.

Number of participants with complete response (CR), partial response (PR), or stable disease (SD) as best overall response among participants with baseline target lesions per RECIST v1.1.

Time from first dose of nivolumab plus ipilimumab to treatment discontinuation.

Total number of administered cycles of nivolumab plus ipilimumab given every 3 weeks, summarized per participant.

Number of participants who discontinue nivolumab plus ipilimumab.

Distribution of reasons, including disease progression, adverse events death, participant request, transfer, or other reasons as assessed by treating clinician.

Number of participants experiencing IMAEs, defined as treatment-related adverse events with immune-mediated etiology, categorized by CTCAE v5.0 grade (1-5).

Time from treatment initiation to onset of immune-mediated adverse events.

Time from onset of immune-mediated adverse events to resolution.

Number of participants experiencing treatment-related adverse events categorized by preferred term and CTCAE v5.0 grade.

Time from treatment initiation to onset of immune-mediated adverse events.

Time from onset of immune-mediated adverse events to resolution.

Time from first documented complete response (CR) or partial response (PR) to disease progression per RECIST v1.1 or death from any cause, whichever occurs first

Time from first dose of nivolumab plus ipilimumab to death from any cause.

Time from first dose of nivolumab plus ipilimumab to first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first.

Time from first dose of nivolumab plus ipilimumab to progression after second-line therapy or death from any cause, whichever occurs first.

Maximum percentage reduction from baseline in the sum of diameters of target lesions among participants with measurable disease.

Change from baseline in Child-Pugh score (range 5-15), including classification into Class A, B, or C.

Number of participants who receive any subsequent anticancer therapy after discontinuation of nivolumab plus ipilimumab

Distribution of subsequent therapies received after discontinuation of nivolumab plus ipilimumab, including transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), radiofrequency ablation (RFA), surgery, radiation therapy, and systemic therapies.