ONO-4538/CA2099X8 Phase 2/3 Study(ONO-4538-72/CA2099X8)

An Open-Label Exploratory Phase 2/3 Study of Nivolumab with Standard of Care Therapy vs Standard of Care Therapy for First-Line Treatment of Metastatic Colorectal Cancer(ONO-4538-72/CA2099X8)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223856

Enrollment

180

Registered

2018-04-03

Start date

2018-03-15

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

Colorectal cancer

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.Histologically confirmed metastatic colorectal cancer, not amenable to curative resection. 2.ECOG Performance Status of 0-1.

Exclusion criteria

Exclusion criteria: 1.Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways 2.Any positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus

Design outcomes

Primary

Measure	Time frame
efficacy PFS	—

Secondary

Measure	Time frame
safety efficacy ORR, OS, DCR	—

Countries

Europe, Japan, North America, Puerto Rico

Outcome results

None listed

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