ONO-4538 Phase II (Rollover) Study (ONO-4538-98)

A Multicenter, Open-label, Phase II Pan-Tumor Study in Patients Who Have Participated in Trials to Investigate Efficacy and Safety of ONO-4538 as Monotherapy or in Combination with Other Therapies and Are Continuing ONO-4538 Treatment (ONO-4538-98)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225345

Enrollment

Registered

2020-08-25

Start date

2020-08-31

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

Pan-Tumor

Interventions

Monotherapy cohort:ONO-4538 will be intravenously infused either as 240 mg Q2W or 480 mg Q4W, as selected by the principal investigator or subinvestigator. Combination therapy cohort:ONO-4538 at 360

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Participant who is being treated with ONO-4538 as monotherapy or in Combination with Other Therapies in clinical trials 2. Participant who is eligible for ONO-4538 monotherapy or in combination with other therapies as per the clinical trials, and/or investigator-assessed clinical benefit

Exclusion criteria

Exclusion criteria: 1. Participant judged to be incapable of providing consent for reasons such as concurrent dementia 2. Participant judged by the investigator to be inappropriate as participants of this study

Design outcomes

Primary

Measure	Time frame
safety Incidence of AEs	—

Countries

Asia except Japan, Japan

Outcome results

None listed

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