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. ]

Proportion of subjects in the analysis population who have a radiographic response according to RECIST 1.1.


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. ]

The time from the first day of study treatment to death due to any cause.


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