ONO-4538 Phase II Rollover Study (ONO-4538-98)

Ono Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Pan-tumor

Treatments: Drug: oxaliplatin; Drug: ONO-4538; Drug: S-1; Drug: temozolomide; Drug: bevacizumab; Drug: capecitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04566380

jRCT2080225345 (Registry Identifier)

ONO-4538-98

Details and patient eligibility

About

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.

Enrollment: 59 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 2 patient groups

ONO-4538 Monotherapy cohort

Experimental group

Description:

480 mg of ONO-4538 IV Q4W or 240 mg of ONO-4538 IV Q2W per the investigator's choice

Treatment:

Drug: ONO-4538

Combination therapy cohort

Experimental group

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.

Treatment:

Drug: bevacizumab

Drug: capecitabine

Drug: temozolomide

Drug: S-1

Drug: ONO-4538

Drug: oxaliplatin