Health Trials

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

ConditionColorectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOno Pharmaceutical Co., Ltd.

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • ONO-4578
  • Opdivo®
  • Oxaliplatin
  • 5-Fluorouracil
  • Bevacizumab
  • Leucovorin

Treatment groups

144 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Ono Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov