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Clinical Research & Trials

USO 24302

Protocol Number: ONO-4578-10. Protocol Title: 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

 

Disease Types: Gastrointestinal Cancer Research

Eligibility Requirements:

• Histologically confirmed advanced CRC not amenable to curative
resection
• Subjects must have available local test results for microsatellite
stability or MMR & BRAF mutation status
• Subjects with MSI-H/dMMR tumor or BRAF V600E mutation
are excluded
• Subjects must not have received prior systemic therapy for disease
• Subjects must have a tumor that is positive for PD-L1 expression
(defined as CPS ≥ 1)
• Subjects that received 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 are excluded.

For more information on this trial CLICK HERE .

Available at: