Long-term safety evaluation of ONO-4538 in cancer patients
Official 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)
Run by Ono Pharmaceutical Co., Ltd. · NCT04566380 · Data updated 2026-11-12
This study is testing the long-term safety of the cancer treatment ONO-4538 in patients with different tumors who are already receiving this medication.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 16 Years and up |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Ono Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 44 sites (Chiba, Chiba and 43 other locations) |
| Status | Recruiting |
| Started | September 10, 2020 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | October 14, 2026 |
| Trial ID | NCT04566380 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients currently receiving ONO-4538 as part of a clinical trial for their cancer treatment.
✕Probably not a fit
Patients who are unable to provide consent due to cognitive impairments or those deemed inappropriate by the investigator will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to confirm the long-term safety of ONO-4538 in participants with various tumors who are receiving ONO-4538 either alone or in combination with other therapies. Participants must be currently treated with ONO-4538 as part of ongoing clinical trials. The study will monitor the safety profile and any adverse effects associated with the treatment over an extended period.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety of ONO-4538, potentially leading to improved treatment options for cancer patients.
How similar studies have gone: Other studies evaluating the safety of similar therapies have shown promising results, indicating that this approach is supported by prior research.
Who can join: the full rules
Show full inclusion / exclusion 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: 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
Where it's running
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Hiroshima Clinical Site1
Hiroshima, Hiroshima, Japan Recruiting -
Hokkaido Clinical Site1
Sapporo, Hokkaido, Japan Recruiting -
Kyoto Clinical Site1
Kyoto, Kyoto, Japan Recruiting -
Oita Clinical Site1
Yufu, Oita Prefecture, Japan Recruiting -
Okayama Clinical Site1
Okayama, Okayama-ken, Japan Recruiting -
Osaka Clinical Site2
Osaka, Osaka, Japan Recruiting
Show 38 more locations
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Osaka Clinical Site1
Suita, Osaka, Japan Recruiting -
Osaka Clinical Site3
Takatsuki, Osaka, Japan Recruiting -
Saitama Clinical Site1
Hidaka, Saitama, Japan Recruiting -
Tokyo Clinical Site3
Bunkyo-ku, Tokyo, Japan Recruiting -
Tokyo Clinical Site2
Chuo-ku, Tokyo, Japan Recruiting -
Tokyo Clinical Site5
Koto-Ku, Tokyo, Japan Recruiting -
Tokyo Clinical Site4
Shinjuku-ku, Tokyo, Japan Recruiting -
Daegu Clinical Site1
Daegu, South Korea, South Korea Recruiting -
Daegu Clinical Site2
Daegu, South Korea Recruiting -
Daegu Clinical Site3
Daegu, South Korea Recruiting -
Gyeonggi-do Clinical site1
Gyeonggi-do, South Korea Recruiting -
Hwasun Clinical Site1
Hwasun, South Korea Recruiting -
Seoul Clinical Site1
Seoul, South Korea Recruiting -
Seoul Clinical Site3
Seoul, South Korea Recruiting -
Seoul Clinical Site4
Seoul, South Korea Recruiting -
Seoul Clinical Site5
Seoul, South Korea Recruiting -
Seoul Clinical Site6
Seoul, South Korea Recruiting -
Suwon Clinical Site1
Suwon, South Korea Recruiting -
Taoyuan Clinical Site1
Taoyuan, Taiwan, Taiwan Recruiting -
New Taipei City Clinical Site1
New Taipei City, Taiwan Recruiting -
Tainan Clinical Site1
Tainan, Taiwan Recruiting -
Tainan Clinical Site2
Tainan, Taiwan Recruiting -
Taipei Clinical Site1
Taipei, Taiwan Recruiting -
Taipei Clinical Site2
Taipei, Taiwan Recruiting -
Chiba Clinical Site2
Chiba, Chiba, Japan Completed -
Chiba Clinical Site1
Kashiwa, Chiba, Japan Completed -
Ehime Clinical Site1
Matsuyama, Ehime, Japan Completed -
Fukuoka Clinical Site2
Fukuoka, Fukuoka, Japan Completed -
Fukuoka Clinical Site3
Fukuoka, Fukuoka, Japan Completed -
Fukuoka Clinical Site1
Kurume, Fukuoka, Japan Completed -
Hyogo Clinical Site1
Akashi, Hyōgo, Japan Completed -
Kanagawa Clinical Site1
Yokohama, Kanagawa, Japan Completed -
Saitama Clinical Site2
Kitaadachi-gun, Saitama, Japan Completed -
Tokyo Clinical Site1
Koto-ku, Tokyo, Japan Completed -
Incheon Clinical Site1
Incheon, South Korea Completed -
Seoul Clinical Site2
Seoul, South Korea Completed -
Kaohsiung Clinical Site1
Kaohsiung City, Taiwan Completed -
Kaohsiung Clinical Site2
Kaohsiung City, Taiwan Completed
Study contacts
- Study coordinator: North America Clinical Trial Support Desk
- Email: clinical_trial@ono-pharma.com
- Phone: +18665877745(Toll-Free)
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.