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

JRCT ID: jRCT2080224169

Registered date:

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Patients with distant metastatic pancreatic cancer who have not previously received chemotherapy
• Date of first enrollment: 03/12/2018
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc : Nivolumab (ONO-4538/BMS-936558), Oxaliplatin, Levofolinate, Fluorouracil and Irinotecan
INN of investigational material : Nivolumab, Oxaliplatin, Levofolinate, Fluorouracil and Irinotecan
Therapeutic category code : 42- Antineoplastic agents
Dosage and Administration for Investigational material : Intravenous injection

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

Outcome(s)

Primary Outcome

safety
efficacy
Objective response rate (ORR)

Secondary Outcome

safety
efficacy
Overall survival (OS)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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)

Exclude 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

Related Information

• Primary Sponsor: ONO PHARMACEUTICAL CO.,LTD.
• Secondary Sponsor: -
• Source(s) of Monetary Support: -
• Secondary ID(s): JapicCTI-184230