Syndax and Merck have entered into a clinical trial collaboration to evaluate the safety and efficacy of combining entinostat, an investigational epigenetic therapy, with KEYTRUDA (pembrolizumab), the first anti-PD-1 therapy approved in the United States.
The Phase 1b/2 study will evaluate this novel combination regimen in patients with either advanced non-small cell lung cancer (NSCLC) or melanoma.
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The study is expected to begin enrolling patients in the second half of 2015.
The financial terms and additional details of the agreement between Syndax and Merck, through a subsidiary, were not disclosed.
The agreement includes a provision where the parties may extend the collaboration to include a potential Phase 3 clinical trial.
The planned Phase 1b/2 multicenter, open-label clinical trial will be conducted in two parts.
The Phase 1b portion is designed to determine the safety and tolerability of entinostat in combination with KEYTRUDA.
The Phase 2 portion is designed to evaluate the efficacy of entinostat combined with KEYTRUDA in patients with advanced NSCLC and melanoma.
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