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
Recruiting · NCT06948448 · Interventional (participants receive a specific treatment) · Lead sponsor: Ono Pharmaceutical Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
- ther protocol-defined inclusion/exclusion criteria apply
Where it is running
39 locations listed across 9 US states.
- Mayo Clinic Arizona - Phoenix, Arizona, United States
- USC Norris Comprehensive Cancer Center - Los Angeles, California, United States
- Rocky Mountain Cancer Centers, LLP - Lone Tree, Colorado, United States
- Mayo Clinic Florida - Jacksonville, Florida, United States
- Advent Health - Orlando, Florida, United States
- May Clinic Rochester - Rochester, Minnesota, United States
- The Ohio State University Comprehensive Cancer Center - Columbus, Ohio, United States
- Thomas Jefferson University, Sidney Kimmel Cancer Center - Philadelphia, Pennsylvania, United States
- Baylor Scott & White Medical Center - Temple, Texas, United States
- Virginia Oncology Associates - Norfolk, Virginia, United States
- Blue Ridge Cancer Care - Salem, Virginia, United States
- Institut Catala d'Oncologia (H. Germans Trias I Pujol, ICO-Barcelona) - Badalona, Barcelona, Spain
- Hosptial Universitari Vall d'Hebron - Barcelona, Barcelona, Spain
- Hospital Universitario Reina Sofia - Córdoba, Córdoba, Spain
- CHU Besançon - Hôpital Jean Minjoz - Besançon, Doubs, France
- CHU Bordeaux - Hôpital Haut-Lévêque - Pessac, Gironde, France
- Azienda Socio Sanitaria Territoriale Niguarda - Milan, Italy, Italy
- Istituto Clinico Humanitas - Milan, Italy, Italy
- Istituto Europeo di Oncologia - Milan, Italy, Italy
- Kobe City Medical Center General Hospital - Hyōgo, Kobe-shi, Japan
- Chru De Nantes Hotel-Dieu - Nantes, Loire Atlantique, France
- Hospital Universitario 12 de Octubre - Madrid, Madrid, Spain
- Hôpital de la Timone - Marseille, Marseille, France
- AOU Uni degli Studi Della Campania Lugi Vanvitelli - Naples, Napoli, Italy
- Istituto Nazionale Tumori Fondazione G. Pascale - Naples, Napoli, Italy
- The Ottawa Hospital Cancer Centre - Ottawa, Ontario, Canada
- Princess Margaret Cancer Centre- University Health Network - Toronto, Ontario, Canada
- National Hospital Organization Osaka National Hospital - Osaka, Osaka-shi, Japan
- Osaka General Medical Center - Osaka, Osaka-shi, Japan
- Osaka International Cancer Institute - Osaka, Osaka-shi, Japan
- IOV-Istituto Oncologico - Padova, Padova, Italy
- Hôpital Européen Georges Pompidou - Paris, Paris, France
- Hôpital Saint-Antoine - Paris, Paris, France
- Jewish General Hospital - Montreal, Quebec, Canada
- Centre Leon Berard - Lyon, Rhone, France
- Hospital Universitario Virgen del Rocio - Seville, Sevilla, Spain
- Hospital Regional Universitario de Malaga - Málaga, Spain, Spain
- Hospital General Universitario de Valencia - Valencia, Valencia, Spain
- CHU Poitiers - Hôpital la Milétrie - Poitiers, Vienne, France