Clinical Trial: Pembrolizumab-based Therapy in Previously Treated High Grade Neuroendocrine Carcinomas
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: A Pilot Study of Pembrolizumab-based Therapy in Previously Treated High Grade Neuroendocrine Carcinomas
Brief Summary: This is a pilot study of pembrolizumab-based therapy in previously treated extrapulmonary poorly differentiated neuroendocrine carcinoma
Detailed Summary: There are two parts of the study. In Part A, subjects are treated with pembrolizumab alone, and in Part B with pembrolizumab plus chemotherapy (physician's choice, paclitaxel or irinotecan). Adaptive Simon's two-stage design is used. The overall plan hinges on the activity of single agent pembrolizumab in the first stage of Part A. If there is sufficient activity in the first stage of Part A, the study will expand to the second stage of Part A and forgo Part B. If there is insufficient activity in the first stage of Part A, the study will proceed to the first stage of Part B (pembrolizumab plus chemotherapy).
Sponsor: University of California, San Francisco
Current Primary Outcome: Overall Response Rate [ Time Frame: Over the duration of the study, which is estimated to be approximately 32 months. ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Overall Survival [ Time Frame: Over the duration of the study, which is estimated to be approximately 32 months. ]
Original Secondary Outcome: Same as current
Information By: University of California, San Francisco
Dates:
Date Received: April 18, 2017
Date Started: June 1, 2017
Date Completion: June 1, 2020
Last Updated: May 4, 2017
Last Verified: May 2017