First-Line Nivolumab Plus Ipilimumab in Unresectable Hepatocellular Carcinoma (J-PROMISE)
← catalyst calendarNCT07679061 · readout in 559 d
Sponsored by Bristol-Myers Squibb (industry) · BMY — their whole pipeline →. With Ono Pharmaceutical Co., Ltd..
Phase
—
Status
Recruiting
Study type
Observational
Enrollment
200estimated
Sites
2
Country
Japan
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-03-05 | actual | When the study began enrolling |
| Primary completion | 2028-02-29 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-02-29 | estimated | The whole study's end, after follow-up |
| First posted | 2026-07-01 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-01 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Unresectable Hepatocellular Carcinoma
Intervention
- Combination product: Nivolumab plus ipilimumab
Primary outcomes
what the primary-completion date above is the date OFNumber of participants with grade ≥3 immune-mediated liver injury (IMLI)
measured Up to 2 years
Time to onset of immune-mediated liver injury (IMLI)
measured Up to 2 years
Time to resolution of immune-mediated liver injury (IMLI)
measured Up to 2 years
Number of participants with immune-mediated liver injury (IMLI) who achieve resolution (recovered, recovering, or recovered with sequelae)
measured Up to 2 years
Treatment prescribed to participants for immune-mediated liver injury (IMLI)
measured Up to 2 years
Objective response rate (ORR)
measured Up to 2 years
Best overall response (BOR)
measured Up to 2 years
Disease control rate (DCR
measured Up to 2 years
Duration of nivolumab plus ipilimumab combination therapy
measured Up to 2 years
Number of nivolumab plus ipilimumab treatment cycles per participant
measured Up to 2 years
Number of participants who discontinue treatment
measured Up to 2 years
Reasons for treatment discontinuation
measured Up to 2 years
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