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

NCT ID: NCT06540261

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-23

Study Completion Date

2027-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Unresectable Colorectal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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ONO-7913+ONO-4538+FOLFOX+Bev

Group Type EXPERIMENTAL

ONO-7913

Intervention Type DRUG

Specified dose on specified days

ONO-4538

Intervention Type DRUG

Specified dose on specified days

Fluorouracil

Intervention Type DRUG

Specified dose on specified days

Oxaliplatin

Intervention Type DRUG

Specified dose on specified days

Levofolinate

Intervention Type DRUG

Specified dose on specified days

Bevacizumab

Intervention Type DRUG

Specified dose on specified days

ONO-7913+ONO-4538+FOLFOX+Cet

Group Type EXPERIMENTAL

ONO-7913

Intervention Type DRUG

Specified dose on specified days

ONO-4538

Intervention Type DRUG

Specified dose on specified days

Fluorouracil

Intervention Type DRUG

Specified dose on specified days

Oxaliplatin

Intervention Type DRUG

Specified dose on specified days

Levofolinate

Intervention Type DRUG

Specified dose on specified days

Cetuximab

Intervention Type DRUG

Specified dose on specified days

Interventions

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ONO-7913

Specified dose on specified days

Intervention Type DRUG

ONO-4538

Specified dose on specified days

Intervention Type DRUG

Fluorouracil

Specified dose on specified days

Intervention Type DRUG

Oxaliplatin

Specified dose on specified days

Intervention Type DRUG

Levofolinate

Specified dose on specified days

Intervention Type DRUG

Bevacizumab

Specified dose on specified days

Intervention Type DRUG

Cetuximab

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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Magrolimab Nivolumab

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fujita Health University Hospital

Toyoake, Aichi-ken, Japan

Site Status

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Site Status

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Site Status

Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Site Status

St. Marianna University Hospital

Kawasaki, Kanagawa, Japan

Site Status

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

Site Status

Kurashiki Central Hospital

Kurashiki, Okayama-ken, Japan

Site Status

Kansai Medical University Hospital

Hirakata, Osaka, Japan

Site Status

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, Osaka, Japan

Site Status

Saitama Medical University International Medical Center

Hidaka, Saitama, Japan

Site Status

Saitama Cancer Center

Shinden, Saitama, Japan

Site Status

Cancer Institute Hospital of JFCR

Koto-Ku, Tokyo, Japan

Site Status

National Cancer Center Hospital

Chūōku, Toyko, Japan

Site Status

Chiba Cancer Center

Chiba, , Japan

Site Status

National Hospital Organization Osaka National Hospital

Osaka, , Japan

Site Status

Osaka General Medical Center

Osaka, , Japan

Site Status

Osaka International Cancer Institute

Osaka, , Japan

Site Status

Countries

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Japan

Other Identifiers

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ONO-7913-04

Identifier Type: -

Identifier Source: org_study_id

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