Fact CheckerSign in

NCT06948448RecruitingPhase 2

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

A Randomized, Open Label, Multicenter, Phase 2 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 for First-line Treatment of Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer

Source: ClinicalTrials.gov · Last updated 16 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
144 (estimated)
First submitted
21 Apr 2025
Start date
18 Nov 2025
Primary completion date
15 Feb 2028
Lead sponsor
Ono Pharmaceutical Co., Ltd.
NCT number
NCT06948448

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 144
  • From 18 Nov 2025 to the primary completion date, 15 Feb 2028
  • 39 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • Participants with complication or history of interstitial lung disease, pneumonitis or pulmonary fibrosis
  • Participants with an active, known or suspected autoimmune disease.

Other

  • Participants with high microsatellite instability (MSI-High), or mismatch repair deficient (dMMR) tumor
  • Participants with BRAF V600E mutation
  • Unable to swallow tablets.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (39)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Jewish General Hospital
Coordinator of this site? Confirm its status
MontrealCanadaRecruiting
The Ottawa Hospital Cancer Centre
Coordinator of this site? Confirm its status
OttawaCanadaRecruiting
Princess Margaret Cancer Centre - University Health Network
Coordinator of this site? Confirm its status
TorontoCanadaRecruiting
Institut Catala d'Oncologia (H. Germans Trias I Pujol, ICO-Barcelona)
Coordinator of this site? Confirm its status
BadalonaSpainRecruiting
Hosptial Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Universitario Reina Sofia
Coordinator of this site? Confirm its status
CórdobaSpainRecruiting
Hospital Universitario 12 de Octubre
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Regional Universitario de Malaga
Coordinator of this site? Confirm its status
MálagaSpainRecruiting
Hospital Universitario Virgen del Rocio
Coordinator of this site? Confirm its status
SevilleSpainRecruiting
Hospital General Universitario de Valencia
Coordinator of this site? Confirm its status
ValenciaSpainRecruiting
CHU Besancon - Hopital Jean Minjoz
Coordinator of this site? Confirm its status
BesançonFranceRecruiting
Centre Leon Berard
Coordinator of this site? Confirm its status
LyonFranceRecruiting
Hopital de la Timone
Coordinator of this site? Confirm its status
MarseilleFranceRecruiting
Chru De Nantes Hotel-Dieu
Coordinator of this site? Confirm its status
NantesFranceRecruiting
Hôpital Saint-Antoine
Coordinator of this site? Confirm its status
ParisFranceRecruiting
Hôpital Européen Georges Pompidou
Coordinator of this site? Confirm its status
ParisFranceRecruiting
CHU Bordeaux - Hopital Haut-Leveque
Coordinator of this site? Confirm its status
PessacFranceRecruiting
CHU Poitiers - Hôpital la Milétrie
Coordinator of this site? Confirm its status
PoitiersFranceRecruiting
Azienda Socio Sanitaria Territoriale Niguarda
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Istituto Europeo di Oncologia
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Istituto Clinico Humanitas
Coordinator of this site? Confirm its status
MilanItalyRecruiting
AOU Uni degli Studi Della Campania Lugi Vanvitelli
Coordinator of this site? Confirm its status
NaplesItalyRecruiting
Istituto Nazionale Tumori Fondazione G. Pascale
Coordinator of this site? Confirm its status
NaplesItalyRecruiting
IOV-Istituto Oncologico
Coordinator of this site? Confirm its status
PadovaItalyRecruiting
Kobe City Medical Center General Hospital
Coordinator of this site? Confirm its status
HyōgoJapanRecruiting
Osaka General Medical Center
Coordinator of this site? Confirm its status
OsakaJapanRecruiting
Osaka International Cancer Institute
Coordinator of this site? Confirm its status
OsakaJapanRecruiting
National Hospital Organization Osaka National Hospital
Coordinator of this site? Confirm its status
OsakaJapanRecruiting
The Ohio State University Comprehensive Cancer Center
Coordinator of this site? Confirm its status
ColumbusUnited StatesRecruiting
Mayo Clinic Florida
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesRecruiting
Rocky Mountain Cancer Centers,LLP
Coordinator of this site? Confirm its status
Lone TreeUnited StatesRecruiting
USC / Norris Comprehensive Cancer Center
Coordinator of this site? Confirm its status
Los AngelesUnited StatesRecruiting
Virginia Oncology Associates
Coordinator of this site? Confirm its status
NorfolkUnited StatesRecruiting
Advent Health
Coordinator of this site? Confirm its status
OrlandoUnited StatesRecruiting
Thomas Jefferson University, Sidney Kimmel Cancer Center
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting
Mayo Clinic - Arizona
Coordinator of this site? Confirm its status
PhoenixUnited StatesRecruiting
May Clinic Rochester
Coordinator of this site? Confirm its status
RochesterUnited StatesRecruiting
Blue Ridge Cancer Care
Coordinator of this site? Confirm its status
SalemUnited StatesRecruiting
Baylor Scott & White Medical Center
Coordinator of this site? Confirm its status
TempleUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.