Clinical trial Recruiting at 30 sites Phase 2 Interventional Ages 16 and up

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

PhasePhase 2
Study typeInterventional
Ages16 Years and up
SexAll
Enrollment70 (estimated)
SponsorOno Pharmaceutical Co., Ltd.
Industry-sponsored
Locations44 sites (Chiba, Chiba and 43 other locations)
StatusRecruiting
StartedSeptember 10, 2020
Main results expectedDecember 31, 2027
Study endsDecember 31, 2027
Registry record updatedOctober 14, 2026
Trial IDNCT04566380 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.