A Phase 3 Study of ONO-4538(ONO-4538-56/CA209901)

A Phase 3, Open-label, Randomized Study of Nivolumab Combined with Ipilimumab, or with Standard of Care Chemotherapy, versus Standard of Care Chemotherapy in Participants with Previously Untreated Unresectable or Metastatic Urothelial Cancer(ONO-4538-56/CA209901)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223696

Enrollment

1290

Registered

2017-10-31

Start date

2017-03-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urothelial carcinoma

Interventions

investigational material(s) Generic name etc : Nivolumab (ONO-4538/BMS-936558), Ipimlimumab (BMS-734016), Gemcitabine and Cisplatin INN of investigational material : Nivolumab, Ipilimumab, Gemcitabine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Metastatic or inoperable urothelial cancer 2. Must have at least 1 lesion with measurable disease 3. No prior systemic chemotherapy treatment in the metastatic setting

Exclusion criteria

Exclusion criteria: 1. Patients with active brain metastases or leptomeningeal metastases 2. Patients with active, known or suspected autoimmune disease 3. Prior treatment with an anti-PD1, anti-PDL1, anti-PDL2, anti-CD137, or anti-CTLA4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Design outcomes

Primary

Measure	Time frame
efficacy Overall Survival in cisplatin-ineligible subjects, and Progression Free Survival and Overall Survival in cisplatin-eligible subjects	—

Secondary

Measure	Time frame
efficacy Progression Free Survival, Overall Survival, Health-Related QOL, etc. in all subjects	—

Countries

Japanetc

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026