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Taking people in JapanPhase 2

Long-term safety of ONO-4538 in people with various cancers

Checks long-term safety of ONO-4538 in people with cancer continuing prior treatment.

Plain-language title generated from the registry record
Registry title: ONO-4538 Phase II Rollover Study (ONO-4538-98)

Key facts

Where
Akashi, Bunkyo-ku, Chiba, Chuo-ku, Fukuoka, Hidaka, Hiroshima, Kashiwa, Kitaadachi-gun, Koto-ku, Koto-Ku, Kurume, Kyoto, Matsuyama, Okayama, Osaka, Sapporo, Shinjuku-ku, Suita, Takatsuki, Yokohama, and Yufu, JapanSee the 23 sites
Phase
Phase 2

Where in Japan

  • AkashiAkashi, JapanNo longer taking part
  • Bunkyo-kuBunkyo-ku, JapanTaking people
  • ChibaChiba, JapanNo longer taking part
  • Chuo-kuChuo-ku, JapanTaking people
  • FukuokaFukuoka, JapanNo longer taking part
  • FukuokaFukuoka, JapanNo longer taking part
  • HidakaHidaka, JapanTaking people
  • HiroshimaHiroshima, JapanTaking people
  • KashiwaKashiwa, JapanNo longer taking part
  • Kitaadachi-gunKitaadachi-gun, JapanNo longer taking part
  • Koto-kuKoto-ku, JapanNo longer taking part
  • Koto-KuKoto-Ku, JapanTaking people
  • KurumeKurume, JapanNo longer taking part
  • KyotoKyoto, JapanTaking people
  • MatsuyamaMatsuyama, JapanNo longer taking part
  • OkayamaOkayama, JapanTaking people
  • OsakaOsaka, JapanTaking people
  • SapporoSapporo, JapanTaking people
  • Shinjuku-kuShinjuku-ku, JapanTaking people
  • SuitaSuita, JapanTaking people
  • TakatsukiTakatsuki, JapanTaking people
  • YokohamaYokohama, JapanNo longer taking part
  • YufuYufu, JapanTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Ono Pharmaceutical Co., Ltd.
Trial code
NCT04566380
Record updated
14 October 2026
Original description
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.Read full original descriptionShow less

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)

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.

Inclusion: 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: 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.

ClinicalTrials.gov NCT04566380