Phase 1 Study of ONO-4538 and ONO-7703(ONO-7703-01/ONO-4538-68)

Open-label, non-comparative study of combination use of ONO-4538 and ONO-7703 in patients with advanced or metastatic solid tumors(ONO-7703-01/ONO-4538-68)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223818

Enrollment

Registered

2018-02-21

Start date

2018-04-26

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

Solid tumors

Interventions

investigational material(s) Generic name etc : ONO-7703/ONO-4538 INN of investigational material : Binimetinib, Nivolumab Therapeutic category code : 429 Other antitumor agents Dosage and Administrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with histologically or cytologically confirmed advanced or metastatic solid tumors 2. Patients with refractory or intolerant to any standard treatment regimen, or no applicable to standard treatment regimen 3. Patients with life expectancy of at least 3 months

Exclusion criteria

Exclusion criteria: 1. Patients with current or past history of severe hypersensitivity to any other antibody products 2. Patients with multiple cancers

Design outcomes

Primary

Measure	Time frame
safety Safety, tolerability	—

Secondary

Measure	Time frame
efficacy pharmacokinetics Pharmacokinetics, OS, PFS, ORR	—

Countries

Japan

Outcome results

None listed

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