Pembrolizumab for the Treatment of Recurrent High Grade Neuroendocrine Carcinoma (Pembro NEC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03190213|
Recruitment Status : Terminated (Update on clinical development: after discussions with the drug manufacturer, the PI has decided to discontinue the trial.)
First Posted : June 16, 2017
Last Update Posted : June 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors||Drug: Pembrolizumab Injection||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is an open label, non-randomized phase 2 study|
|Masking:||None (Open Label)|
|Official Title:||Pembrolizumab for the Treatment of Recurrent High Grade Neuroendocrine Carcinoma|
|Actual Study Start Date :||December 4, 2017|
|Actual Primary Completion Date :||December 13, 2018|
|Actual Study Completion Date :||March 11, 2019|
|Experimental: Pembrolizumab, all patients||
Drug: Pembrolizumab Injection
Pembrolizumab at a dose of 200 mg will be administered as an IV infusion over 30 minutes every 3 weeks until disease recurrence or discontinuation due to unacceptable toxicity for a maximum of 2 years. We anticipate on average patients will remain on treatment for approximately 24 weeks.
- Overall response rate (irPR (partial response) + irCR (complete response)) using immune related (ir)RECIST [ Time Frame: 2 years ]To evaluate overall response rate of pembrolizumab (irPR + irCR) using immune related (ir)RECIST in patients with non-pulmonary high grade neuroendocrine carcinoma.
- Clinical Benefit Rate [ Time Frame: 2 years ]To evaluate clinical benefit rate of pembrolizumab (irPR + irCR + irSD (stable disease)) using irRECIST in this setting.
- Progression Free Survival [ Time Frame: 4 years ]To evaluate progression free survival of patients treated with pembrolizumab in this setting.
- Median Overall Survival [ Time Frame: 4 years ]To evaluate the median overall survival (OS) of patients treated with pembrolizumab in this setting
- Adverse Events that Occur [ Time Frame: 2 years, assessed checked at every visit in that time period ]To evaluate safety and tolerability of the pembrolizumab in this setting.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03190213
|United States, Utah|
|Huntsman Cancer Institute|
|Salt Lake City, Utah, United States, 84112|