A Phase 3 Study of ONO-4538/BMS-936558(ONO-4538-33/CA209274)

A phase III randomized, double-blind, multi-center study of adjuvant nivolumab versus placebo in subjects with high risk invasive urothelial carcinoma(ONO-4538-33/CA209274)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223108

Enrollment

700

Registered

2016-02-19

Start date

2016-02-11

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 : ONO-4538/BMS-936558 INN of investigational material : Nivolumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Inve

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Must have had invasive urothelial carcinoma at high risk of recurrence originating in the bladder, ureter, or renal pelvis 2. Must have had radical surgical resection (e.g. radical cystectomy), performed within the last 120 days 3. Must have disease-free status as determined by imaging within 4 weeks of dosing

Exclusion criteria

Exclusion criteria: 1. Subjects with active, known or suspected autoimmune disease 2. Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured 3. Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection

Design outcomes

Primary

Measure	Time frame
efficacy Disease free survival	—

Secondary

Measure	Time frame
efficacy Non-urothelial tract recurrence free survival, Disease specific survival, Overall survival, etc.	—

Countries

Asia except Japan, Europe, Japan, North America, Oceania, South America

Outcome results

None listed

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