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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 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

RecruitingPhase 2

Sponsor: Ono Pharmaceutical Co., Ltd.

Conditions: Colorectal Cancer

Interventions: ONO-4578, Opdivo®, Oxaliplatin, 5-Fluorouracil, Bevacizumab

Countries: United States, Canada, France, Italy, Japan, Spain

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (39)
  • Phoenix, Arizona, United States
  • Los Angeles, California, United States
  • Lone Tree, Colorado, United States
  • Jacksonville, Florida, United States
  • Orlando, Florida, United States
  • Rochester, Minnesota, United States
  • Columbus, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • Temple, Texas, United States
  • Norfolk, Virginia, United States
  • Salem, Virginia, United States
  • Ottawa, Ontario, Canada
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • Besançon, Doubs, France
  • Pessac, Gironde, France
  • Nantes, Loire Atlantique, France
  • Marseille, Marseille, France
  • Paris, Paris, France
  • Paris, Paris, France
  • Lyon, Rhone, France
  • Poitiers, Vienne, France
  • Milan, Italy, Italy
  • Milan, Italy, Italy
  • Milan, Italy, Italy
  • Naples, Napoli, Italy
  • Naples, Napoli, Italy
  • Padova, Padova, Italy
  • Hyōgo, Kobe-shi, Japan
  • Osaka, Osaka-shi, Japan
  • + 9 more on CT.gov