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Recruiting

NCT Number: NCT04566380

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

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.

Recruiting

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Key information

Conditions

Pan-tumor

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chiba Clinical Site1, Kashiwa, Chiba, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant who is being treated with ONO-4538 as monotherapy or in Combination with Other Therapies in clinical trials
  • 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

  • Participant judged to be incapable of providing consent for reasons such as concurrent dementia
  • Participant judged by the investigator to be inappropriate as participants of this study

Treatment and study plan

ONO-4538

Drug

IV infusion over 30 minutes

Oxaliplatin

Drug

IV infusion over 2 hours

S-1

Drug

Administered orally twice daily

Capecitabine

Drug

Administered orally twice daily

Bevacizumab

Drug

IV infusion over 30 minutes

Temozolomide

Drug

Administered orally once daily for 5 days every 28 days

Primary outcomes

  1. Incidence of Adverse Events (Aes)

    Time frame: From Day 1 up to 28 days after the end of the treatment phase

    (non)

Study contacts

Contact information is provided by the study sponsor or research team.

International Clinical Trial Support Desk

CONTACT

[email protected]

+17162141777(Standard)

North America Clinical Trial Support Desk

CONTACT

[email protected]

+18665877745(Toll-Free)

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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)

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Sep 28, 2020
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.