FindTrial
Sign In

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
ClinicalTrials.gov
Registry ID
NCT04566380
Enrollment
59
Registered
2020-09-28
Start date
2020-09-10
Completion date
2026-12-31
Last updated
2025-06-03

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

Conditions

Pan-tumor

Brief summary

This study is intended to confirm the long-term safety of ONO-4538 in pan-tumor participants being treated with ONO-4538 monotherapy or in Combination with Other Therapies in clinical trials.

Interventions

DRUGONO-4538

IV infusion over 30 minutes

DRUGoxaliplatin

IV infusion over 2 hours

DRUGS-1

Administered orally twice daily

DRUGcapecitabine

Administered orally twice daily

DRUGbevacizumab

IV infusion over 30 minutes

DRUGtemozolomide

Administered orally once daily for 5 days every 28 days

Sponsors

Ono Pharmaceutical Co. Ltd
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

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

MeasureTime frameDescription
Incidence of Adverse Events (Aes)From Day 1 up to 28 days after the end of the treatment phase(non)

Countries

Japan, South Korea, Taiwan

Contacts

Primary ContactNorth America Clinical Trial Support Desk
clinical_trial@ono-pharma.com+18665877745(Toll-Free)
Backup ContactInternational Clinical Trial Support Desk
clinical_trial@ono-pharma.com+17162141777(Standard)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026