An Open-label, Uncontrolled Study of ONO-7913 and ONO-4538 in Combination With Modified FOLFIRINOX Therapy, the Standard of Care, as First-line Treatment in Patients With Metastatic Pancreatic Cancer

November 11, 2024 updated by: Ono Pharmaceutical Co. Ltd
To investigate the tolerability and safety of ONO-7913 and ONO-4538 used in combination with modified FOLFIRINOX (mFFX therapy), the standard of care, as first-line treatment in patients with metastatic pancreatic cancer.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chuo Ku, Japan
        • National Cancer Center Hospital
    • Chiba
      • Kashiwa-shi, Chiba, Japan
        • National Cancer Center Hospital East
    • Kanagawa
      • Yokohama-shi, Kanagawa, Japan
        • Kanagawa Cancer Center
    • Shizuoka
      • Hamamatsu-shi, Shizuoka, Japan
        • Seirei Hamamatsu General Hospital
    • Tokyo
      • Bunkyō-Ku, Tokyo, Japan
        • The University of Tokyo Hospital
      • Bunkyō-Ku, Tokyo, Japan
        • Juntendo University Hospital
      • Koto-ku, Tokyo, Japan
        • The Cancer Institute Hospital ofJFCR
      • Mitaka-shi, Tokyo, Japan
        • Kyorin University Hospital
      • Shinjuku-Ku, Tokyo, Japan
        • Keio University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. Untreated metastatic pancreatic cancer
  • 2. Life expectancy of at least 3 months
  • 3. Patients with ECOG performance status 0 or 1

Exclusion Criteria:

  • 1. Patients with severe complication
  • 2. Patients with multiple primary cancers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ONO-7913+ONO-4538+mFFX
Drug: Fluorouracil
Specified dose on specified days
Drug: Oxaliplatin
Specified dose on specified days
Drug: Irinotecan
Specified dose on specified days
Drug: ONO-4538
Specified dose on specified days
Other Names:
  • Nivolumab
Drug: ONO-7913
Specified dose on specified days
Other Names:
  • Magrolimab
Drug: Levofolinate
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose-limiting toxicities（DLT）
Time Frame: 28 days
28 days
Adverse event(AE)
Time Frame: UP to 30 days after the last dose
UP to 30 days after the last dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics（serum concentration of ONO-7913）
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months
Pharmacokinetics（serum concentration of ONO-4538）
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months
Overall response rate (ORR)
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months
Disease control rate (DCR)
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months
Overall survival (OS)
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months
Progression-free survival (PFS)
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months
Duration of response (DOR)
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months
Time to response (TTR)
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months
Best overall response (BOR)
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months
Percentage of change in the sum of tumor diameters of target lesions
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months
Maximum percentage of change in the sum of tumor diameters of target lesions
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months
Changes in tumor markers (CEA and CA19-9)
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ono Pharmaceutical Co. Ltd

Investigators

  • Study Director: Project Leader, Ono Pharmaceutical Co. Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

July 29, 2024

First Submitted That Met QC Criteria

July 29, 2024

First Posted (Actual)

August 1, 2024

Study Record Updates

Last Update Posted (Estimated)

November 14, 2024

Last Update Submitted That Met QC Criteria

November 11, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONO-7913-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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