ONO Pharmaceutical Co ((OPHLF)) announced an update on their ongoing clinical study.
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Ono Pharmaceutical Co. Ltd is initiating a Phase 2 clinical study titled ‘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.’ The study aims to assess the safety and efficacy of ONO-4578 combined with Opdivo®, mFOLFOX6, and bevacizumab compared to the standard of care for advanced colorectal cancer patients.
The interventions being tested include two experimental arms with different doses of ONO-4578 combined with Opdivo® and standard chemotherapy drugs (mFOLFOX6 and bevacizumab), compared against a control group receiving only the standard chemotherapy regimen.
This interventional study is designed as a randomized, open-label trial with a parallel assignment. It primarily focuses on treatment efficacy, with no masking involved, allowing all participants and researchers to know the treatment allocations.
The study is set to begin recruiting on April 21, 2025, with its primary completion and estimated overall completion dates yet to be announced. The last update to the study details was also submitted on April 21, 2025, marking the beginning of its active phase.
This study could significantly impact Ono Pharmaceutical’s market position, as successful results may enhance investor confidence and potentially boost stock performance. The study’s progress will be closely watched by investors, especially in the context of competitive pressures within the oncology pharmaceutical sector.
The study is ongoing, with further details available on the ClinicalTrials portal.