A new randomized Phase II trial, OPTIM, is testing an escalation strategy in recurrent or metastatic squamous cell carcinoma of the head and neck, starting with nivolumab and moving to nivolumab–ipilimumab or docetaxel based on response or selection criteria. The study, reported in the British Journal of Cancer, is designed to evaluate whether an adaptive approach can improve outcomes compared with fixed sequencing, shifting the focus from whether immunotherapy works to when and how to apply it. For clinicians and trial teams, OPTIM targets a common practical challenge in HNSCC—treatment selection after initial checkpoint therapy—while using a design intended to generate decision-relevant efficacy and safety signals early in development.
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