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ONO-4578 (NCT06948448)

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 one-minute explainerNCT069484481 min

ONO-4578 trial for Colorectal Cancer (NCT06948448). This is a short film with English narration. The transcript is on this page, and the written brief is separate.

What the film says

Read the transcript

This trial is for adults with unresectable advanced colorectal cancer starting first-line systemic treatment. Tumors must be PDL1-positive and lack MSI-high, mismatch-repair deficiency, and BRAF V600E. Prior checkpoint therapy excludes participation.

The idea: ONO-4578 blocks EP4 signaling linked to immune suppression; nivolumab releases the PD1 immune brake. Randomization adds daily ONO-4578 tablets at either of two doses plus nivolumab to mFOLFOX6 and bevacizumab, or gives mFOLFOX6 and bevacizumab alone. Researchers assess response and safety in four-week cycles.

This phase 2 study plans 144 patients. Ono Pharmaceutical sponsors; eleven US sites recruit.

Public record; not medical advice.

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