The Study of ONO-7913, ONO-4538 and the Standard of Care as First-line Treatment in Patients Colorectal Cancer

August 1, 2024 updated by: Ono Pharmaceutical Co. Ltd

An Open-label, Uncontrolled Study of ONO-7913, ONO-4538 and the Standard of Care FOLFOX in Combination With Bevacizumab or Cetuximab as First-line Treatment in Patients With Unresectable Advanced or Recurrent Colorectal Cancer

To confirm the tolerability and safety of combined administration of ONO-7913, ONO-4538 and the standard of care FOLFOX in combination with bevacizumab or cetuximab as first-line treatment in patients with unresectable advanced or recurrent colorectal cancer

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

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
      • Chiba, Japan
        • Chiba Cancer Center
      • Osaka, Japan
        • Osaka International Cancer Institute
      • Osaka, Japan
        • Osaka General Medical Center
      • Osaka, Japan
        • National Hospital Organization Osaka National Hospital
    • Aichi
      • Toyoake, Aichi, Japan
        • Fujita Health University Hospital
    • Chiba
      • Kashiwa, Chiba, Japan
        • National Cancer Center Hospital East
    • Hokkaido
      • Sapporo, Hokkaido, Japan
        • Hokkaido University Hospital
    • Hyogo
      • Kobe, Hyogo, Japan
        • Kobe City Medical Center General Hospital
    • Kanagawa
      • Kawasaki, Kanagawa, Japan
        • St. Marianna University Hospital
      • Yokohama, Kanagawa, Japan
        • Kanagawa Cancer Center
    • Okayama
      • Kurashiki, Okayama, Japan
        • Kurashiki Central Hospital
    • Osaka
      • Hirakata, Osaka, Japan
        • Kansai Medical University Hospital
      • Takatsuki, Osaka, Japan
        • Osaka Medical and Pharmaceutical University Hospital
    • Saitama
      • Hidaka, Saitama, Japan
        • Saitama Medical University International Medical Center
      • Ina, Saitama, Japan
        • Saitama Cancer Center
    • Tokyo
      • Koto-Ku, Tokyo, Japan
        • Cancer Institute Hospital of JFCR
    • Toyko
      • Chuo Ku, Toyko, Japan
        • National Cancer Center 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. Unresectable advanced or recurrent colorectal 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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ONO-7913＋ONO-4538＋FOLFOX＋Bev
Drug: Fluorouracil
Specified dose on specified days
Drug: Oxaliplatin
Specified dose on specified days
Drug: Bevacizumab
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
Experimental: ONO-7913＋ONO-4538＋FOLFOX＋Cet
Drug: Fluorouracil
Specified dose on specified days
Drug: Cetuximab
Specified dose on specified days
Drug: Oxaliplatin
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（Plasma concentration of ONO-7913）
Time Frame: Through study completion, an average of 1 year.
Through study completion, an average of 1 year.
Pharmacokinetics（Plasma concentration of ONO-4538）
Time Frame: Through study completion, an average of 1 year.
Through study completion, an average of 1 year.
Objective Response Rate (ORR)
Time Frame: Through study completion, an average of 1 year.
Through study completion, an average of 1 year.
Disease Control Rate (DCR)
Time Frame: Through study completion, an average of 1 year.
Through study completion, an average of 1 year.
Overall Survival (OS)
Time Frame: Through study completion, an average of 3 years.
Through study completion, an average of 3 years.
Progression-Free Survival (PFS)
Time Frame: Through study completion, an average of 1 years.
Through study completion, an average of 1 years.
Duration of Response (DOR)
Time Frame: Through study completion, an average of 1 years.
Through study completion, an average of 1 years.
Time to Response (TTR)
Time Frame: Through study completion, an average of 1 years.
Through study completion, an average of 1 years.
Best Overall Response (BOR)
Time Frame: Through study completion, an average of 1 years.
Through study completion, an average of 1 years.
Percent change in the sum diameters of the target lesions
Time Frame: Through study completion, an average of 1 years.
Through study completion, an average of 1 years.
Maximum percent change in the sum diameters of the target lesions
Time Frame: Through study completion, an average of 1 years.
Through study completion, an average of 1 years.
Early Tumor shrinkage（ETS）
Time Frame: Up to 8 weeks
Up to 8 weeks
Change From Baseline in Tumour Biomarkers (CEA and CA19-9)
Time Frame: Through study completion, an average of 1 year.
Through study completion, an average of 1 year.

Collaborators and Investigators

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

Sponsor

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)

September 23, 2021

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

January 31, 2025

Study Registration Dates

First Submitted

August 1, 2024

First Submitted That Met QC Criteria

August 1, 2024

First Posted (Actual)

August 6, 2024

Study Record Updates

Last Update Posted (Actual)

August 6, 2024

Last Update Submitted That Met QC Criteria

August 1, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONO-7913-04

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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