ONO-4538 Phase II Study (ONO-4538-83/TASUKI-83)

A Phase II, multicenter and open-label study of ONO-4538 in patients with pancreatic cancer (ONO-4538-83/TASUKI-83)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224169

Enrollment

Registered

2018-12-03

Start date

2019-01-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with distant metastatic pancreatic cancer who have not previously received chemotherapy

Interventions

investigational material(s) Generic name etc : Nivolumab (ONO-4538/BMS-936558), Oxaliplatin, Levofolinate, Fluorouracil and Irinotecan INN of investigational material : Nivolumab, Oxaliplatin, Levofol

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Sex: Both men and women 2. Age (at the time of informed consent): 20 years and older 3. Patients with histologically or cytologically confirmed pancreatic cancer which has been confirmed to be adenocarcinoma 4. Have distant metastatic pancreatic cancer which has not been treated (except for surgical resection)

Exclusion criteria

Exclusion criteria: 1. Patients with current or previous severe hypersensitivity reactions to other antibody products 2. Patients who are contraindicated for oxaliplatin, irinotecan, 5-fluorouracil or leucovorin calcium 3. Patients with clinically problematic diarrhea (including watery stool) 4. Have peripheral motor neuropathy and peripheral sensory neuropathy

Design outcomes

Primary

Measure	Time frame
safety efficacy Objective response rate (ORR)	—

Secondary

Measure	Time frame
safety efficacy Overall survival (OS)	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026