Fred Hutchinson Cancer Research Center (Fred Hutch) and Alkermes plc (ALKS) inked a collaborative deal where the parties will conduct a Phase II multi-site trial for ALKS 4230, a novel engineered fusion protein designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity interleukin-2 (IL-2) receptor complex.
The clinical trial, known as ION-01, is designed to estimate the response rate to ALKS 4230 in combination with the anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with advanced or recurrent head and neck squamous cell cancer who did not achieve complete remission with an anti-PD(L)1 antibody treatment. The study will commence in the fourth quarter of 2019.
Secondary objectives include evaluation of the duration of response, progression-free survival, time to progression and overall survival of patients with advanced or recurrent head and neck squamous cell cancer receiving treatment with ALKS 4230 in combination with pembrolizumab.
The sponsors and site will assess the tumor microenvironment using pair...
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