Pan-tumor Clinical Trial
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)
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.
| Status | Recruiting |
| Enrollment | 59 |
| Est. completion date | December 31, 2026 |
| Est. primary completion date | December 31, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 16 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Hyogo Clinical Site1 | Akashi | Hyogo |
| Japan | Tokyo Clinical Site3 | Bunkyo-ku | Tokyo |
| Japan | Chiba Clinical Site2 | Chiba | |
| Japan | Tokyo Clinical Site2 | Chuo-ku | Tokyo |
| Japan | Fukuoka Clinical Site2 | Fukuoka | |
| Japan | Fukuoka Clinical Site3 | Fukuoka | |
| Japan | Saitama Clinical Site1 | Hidaka | Saitama |
| Japan | Hiroshima Clinical Site1 | Hiroshima | |
| Japan | Chiba Clinical Site1 | Kashiwa | Chiba |
| Japan | Saitama Clinical Site2 | Kitaadachi-gun | Saitama |
| Japan | Tokyo Clinical Site1 | Koto-ku | Tokyo |
| Japan | Fukuoka Clinical Site1 | Kurume | Fukuoka |
| Japan | Kyoto Clinical Site1 | Kyoto | |
| Japan | Ehime Clinical Site1 | Matsuyama | Ehime |
| Japan | Okayama Clinical Site1 | Okayama | |
| Japan | Osaka Clinical Site2 | Osaka | |
| Japan | Hokkaido Clinical Site1 | Sapporo | Hokkaido |
| Japan | Tokyo Clinical Site4 | Shinjuku-ku | Tokyo |
| Japan | Osaka Clinical Site1 | Suita | Osaka |
| Japan | Osaka Clinical Site3 | Takatsuki | Osaka |
| Japan | Kanagawa Clinical Site1 | Yokohama | Kanagawa |
| Japan | Oita Clinical Site1 | Yufu | Oita |
| Korea, Republic of | Daegu Clinical Site1 | Daegu | |
| Korea, Republic of | Gyeonggi-do Clinical site1 | Gyeonggi-do | |
| Korea, Republic of | Incheon Clinical Site1 | Incheon | |
| Korea, Republic of | Seoul Clinical Site1 | Seoul | |
| Korea, Republic of | Seoul Clinical Site2 | Seoul | |
| Korea, Republic of | Seoul Clinical Site3 | Seoul | |
| Korea, Republic of | Seoul Clinical Site4 | Seoul | |
| Korea, Republic of | Seoul Clinical Site5 | Seoul | |
| Korea, Republic of | Seoul Clinical Site6 | Seoul | |
| Taiwan | Kaohsiung Clinical Site1 | Kaohsiung | |
| Taiwan | Kaohsiung Clinical Site2 | Kaohsiung | |
| Taiwan | Tainan Clinical Site1 | Tainan | |
| Taiwan | Tainan Clinical Site2 | Tainan | |
| Taiwan | Taipei Clinical Site1 | Taipei | |
| Taiwan | Taipei Clinical Site2 | Taipei | |
| Taiwan | Taoyuan Clinical Site1 | Taoyuan |
| Lead Sponsor | Collaborator |
|---|---|
| Ono Pharmaceutical Co. Ltd |
Japan, Korea, Republic of, Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of Adverse Events (Aes) | (non) | From Day 1 up to 28 days after the end of the treatment phase |