Clinical trial · Interventional
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)
NCT04566380CI-TRIAL-00090498recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pan-tumor | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Drug | Bevacizumab | ALIAS |
| capecitabine | Drug | Capecitabine | ALIAS |
| ONO-4538 | Drug | Nivolumab | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| S-1 | Drug | — | UNRESOLVED |
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ONO-4538 Monotherapy cohort
- description
- 480 mg of ONO-4538 IV Q4W or 240 mg of ONO-4538 IV Q2W per the investigator's choice
- interventionNames
- Drug: ONO-4538
- type
- EXPERIMENTAL
- label
- Combination therapy cohort
- description
- ONO-4538 at 360 mg IV Q3W or 480 mg IV Q4W, and Combination therapies (S-1 + Oxaliplatin \[SOX\] therapy , Capecitabine + Oxaliplatin \[CapeOX\] therapy , Bevacizumab or Temozolomide) selected by the principal investigator or subinvestigator in the Parent Study will be continued in this study.
- interventionNames
- Drug: ONO-4538
- Drug: oxaliplatin
- Drug: S-1
- Drug: capecitabine
- Drug: bevacizumab
- Drug: temozolomide
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.