A Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo®, in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care in Participants With Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer

NCT06948448 · tracked via the Priya Life Science USA tracker

Sponsor

Ono Pharmaceutical Co., Ltd.

Phase

Phase 2

Started

2025-11-18

Last updated

2026-07-16

Condition(s) studied

Colorectal Cancer

Investigational drug(s) / intervention(s)

ONO-4578Opdivo®Oxaliplatin5-FluorouracilBevacizumabLeucovorin

ONO-4578: ONO-4578 tablets once a day

Opdivo®: Specified dose on specified days

Oxaliplatin: Specified dose on specified days

5-Fluorouracil: Specified dose on specified days

Bevacizumab: Specified dose on specified days

Leucovorin: Specified dose on specified days

Study summary

The purpose of this study is to evaluate the safety and efficacy of two dose levels of ONO-4578 with Opdivo® when added to mFOLFOX6 and bevacizumab versus SOC as first-line treatment for advanced CRC.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Histologically confirmed advanced (locally advanced or metastatic) colorectal cancer not amenable to curative resection * ECOG Performance Status of 0-1 * No prior systemic treatment for advanced local or mCRC * Participants whose tumor is positive for PD-L1 expression as determined at a central laboratory Exclusion Criteria: * Participants with high microsatellite instability (MSI-High), or mismatch repair deficient (dMMR) tumor * Participants with BRAF V600E mutation * Unable to swallow tablets. * Participants with complication or history of interstitial lung disease, pneumonitis or pulmonary fibrosis * Participants with an active, known or suspected autoimmune disease. * Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways. Other protocol-defined inclusion/exclusion criteria apply

Primary outcome measure(s)

Overall Response Rate (ORR) per Blinded Independent Central Review (BICR) — From randomization to the end of treatment (Up to 39 months)
ORR (assessed by BICR per RECIST v1.1) is defined as the proportion of participants with a BOR of confirmed CR or PR. The ORR will be estimated as the number of participants achieving BOR of CR or PR assessed by BICR per RECIST v1.1 divided by the total number of participants.
Number of participants with Adverse Events (AEs) — From first dose to 28 days post last dose
An AE is any untoward medical occurrence in a patient or clinical study patient, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
Number of participants with Serious Adverse Events (SAEs) — From first dose to 28 days post last dose
SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in significant disability/incapacity.

Trial sites (39)

Facility	City	Region	Status
Mayo Clinic Arizona	Phoenix	Arizona	Recruiting
USC Norris Comprehensive Cancer Center	Los Angeles	California	Recruiting
Rocky Mountain Cancer Centers, LLP	Lone Tree	Colorado	Recruiting
Mayo Clinic Florida	Jacksonville	Florida	Recruiting
Advent Health	Orlando	Florida	Recruiting
May Clinic Rochester	Rochester	Minnesota	Recruiting
The Ohio State University Comprehensive Cancer Center	Columbus	Ohio	Recruiting
Thomas Jefferson University, Sidney Kimmel Cancer Center	Philadelphia	Pennsylvania	Recruiting
Baylor Scott & White Medical Center	Temple	Texas	Recruiting
Virginia Oncology Associates	Norfolk	Virginia	Recruiting
Blue Ridge Cancer Care	Salem	Virginia	Recruiting
The Ottawa Hospital Cancer Centre	Ottawa	Ontario	Recruiting
Princess Margaret Cancer Centre- University Health Network	Toronto	Ontario	Recruiting
Jewish General Hospital	Montreal	Quebec	Recruiting
CHU Besançon - Hôpital Jean Minjoz	Besançon	Doubs	Recruiting
CHU Bordeaux - Hôpital Haut-Lévêque	Pessac	Gironde	Recruiting
Chru De Nantes Hotel-Dieu	Nantes	Loire Atlantique	Recruiting
Hôpital de la Timone	Marseille	Marseille	Recruiting
Hôpital Européen Georges Pompidou	Paris	Paris	Recruiting
Hôpital Saint-Antoine	Paris	Paris	Recruiting
Centre Leon Berard	Lyon	Rhone	Recruiting
CHU Poitiers - Hôpital la Milétrie	Poitiers	Vienne	Recruiting
Azienda Socio Sanitaria Territoriale Niguarda	Milan	Italy	Recruiting
Istituto Clinico Humanitas	Milan	Italy	Recruiting
Istituto Europeo di Oncologia	Milan	Italy	Recruiting
AOU Uni degli Studi Della Campania Lugi Vanvitelli	Naples	Napoli	Recruiting
Istituto Nazionale Tumori Fondazione G. Pascale	Naples	Napoli	Recruiting
IOV-Istituto Oncologico	Padova	Padova	Recruiting
Kobe City Medical Center General Hospital	Hyōgo	Kobe-shi	Recruiting
National Hospital Organization Osaka National Hospital	Osaka	Osaka-shi	Recruiting
Osaka General Medical Center	Osaka	Osaka-shi	Recruiting
Osaka International Cancer Institute	Osaka	Osaka-shi	Recruiting
Institut Catala d'Oncologia (H. Germans Trias I Pujol, ICO-Barcelona)	Badalona	Barcelona	Recruiting
Hosptial Universitari Vall d'Hebron	Barcelona	Barcelona	Recruiting
Hospital Universitario Reina Sofia	Córdoba	Córdoba	Recruiting
Hospital Universitario 12 de Octubre	Madrid	Madrid	Recruiting
Hospital Universitario Virgen del Rocio	Seville	Sevilla	Recruiting
Hospital Regional Universitario de Malaga	Málaga	Spain	Recruiting
Hospital General Universitario de Valencia	Valencia	Valencia	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06948448 on ClinicalTrials.gov ↗ ← All trials in the USA