Trials / Recruiting
RecruitingNCT04566380
ONO-4538 Phase II Rollover Study (ONO-4538-98)
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)
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 59 (estimated)
- Sponsor
- Ono Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ONO-4538 | IV infusion over 30 minutes |
| DRUG | oxaliplatin | IV infusion over 2 hours |
| DRUG | S-1 | Administered orally twice daily |
| DRUG | capecitabine | Administered orally twice daily |
| DRUG | bevacizumab | IV infusion over 30 minutes |
| DRUG | temozolomide | Administered orally once daily for 5 days every 28 days |
Timeline
- Start date
- 2020-09-10
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
- First posted
- 2020-09-28
- Last updated
- 2025-06-03
Locations
38 sites across 3 countries: Japan, South Korea, Taiwan
Source: ClinicalTrials.gov record NCT04566380. Inclusion in this directory is not an endorsement.