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. 2021 May 4;26(9):731–e1498. doi: 10.1002/onco.13795
Disease Melanoma
Stage of Disease/Treatment Metastatic/advanced
Prior Therapy No designated number of regimens
Type of Study Phase II, single arm
Primary Endpoint Overall response rate
Secondary Endpoint Overall response rate, progression‐free survival, safety
Additional Details of Endpoints or Study Design
The trial was open for accrual from January 19, 2015, through July 20, 2018. The study was planned as a two‐stage, two‐cohort design with up to 25 patients per arm (50 total patients). In each arm, if at least one response was observed in the first 15 patients, an additional 10 patients would be accrued. If 4 patients of 25 patients had experienced a response in cohort A, the primary endpoint would have been met.
Investigator's Analysis Active and should be pursued further