A Study of Pembrolizumab in Patients With Neuroendocrine Tumors
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|ClinicalTrials.gov Identifier: NCT02939651|
Recruitment Status : Completed
First Posted : October 20, 2016
Results First Posted : March 9, 2021
Last Update Posted : March 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors||Drug: Pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Open-label Study of Pembrolizumab Monotherapy in Patients With Metastatic High Grade Neuroendocrine Tumors|
|Actual Study Start Date :||October 26, 2016|
|Actual Primary Completion Date :||February 2018|
|Actual Study Completion Date :||March 2020|
Monotherapy with PD-1 antibody pembrolizumab
Pembrolizumab given intravenously at a fixed dose of 200mg every 3 weeks
- Objective Response Rate (ORR) [ Time Frame: Upto 3 years ]To estimate objective response rate (ORR), using RECIST 1.1, in previously treated metastatic High Grade Neuroendocrine Tumors (HGNET) patients treated with pembrolizumab monotherapy. The Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria will be used for objective tumor response assessment: Complete Response (CR):Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters
- Progression Free Survival (PFS) [ Time Frame: Upto 3 years ]To evaluate progression free survival (PFS) (using RECIST 1.1) in metastatic HGNET patients treated with pembrolizumab monotherapy. PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase (at least 5 mm absolute increase) in the sum of the longest diameter of target lesions. PFS was estimated according to the Kaplan-Meier method.
- Overall Survival [ Time Frame: Upto 3 years ]To evaluate overall survival (OS) in metastatic HGNET patients treated with pembrolizumab monotherapy. OS was estimated according to the Kaplan-Meier method.
- Frequency With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: Upto 3 years ]Occurence of toxicity, graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.0.
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): NCT02939651
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States|
|Principal Investigator:||Namrata Vijayvergia, MD||Fox Chase Cancer Center|