Pembrolizumab-based Therapy in Previously Treated High Grade Neuroendocrine Carcinomas
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03136055|
Recruitment Status : Recruiting
First Posted : May 2, 2017
Last Update Posted : April 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|High Grade Malignant Neuroendocrine Carcinoma (Diagnosis)||Drug: Pembrolizumab Drug: Irinotecan Drug: Paclitaxel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||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).|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Pembrolizumab-based Therapy in Previously Treated High Grade Neuroendocrine Carcinomas|
|Actual Study Start Date :||June 20, 2017|
|Estimated Primary Completion Date :||June 19, 2019|
|Estimated Study Completion Date :||June 19, 2020|
Experimental: High-Grade Extrapulmonary NEC
Part A: 200 mg of pembrolizumab will be given every three weeks via IV infusion.
Part B: 200 mg of pembrolizumab will be given every three weeks via IV infusion and, either
200 mg every 3 weeks via IV infusion.
Other Name: Keytruda
For patients in part B receiving pembrolizumab and chemotherapy with irinotecan. The starting dose for the safety lead-in is 125 mg/m2 irinotecan via IV infusion in a 2 weeks on, 1 week off format over 3 week cycles.
If the initial dose is not tolerated, the dose level will be decreased to 100 mg/m2.
Other Name: Camptosar
For patients in part B receiving pembrolizumab and chemotherapy with paclitaxel. Patients will receive 80 mg/m2 of paclitaxel via IV infusion every week, with treatment breaks as needed.
Other Name: Taxol
- 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.
- 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.
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): NCT03136055
|Contact: Emily Bergsland, MDemail@example.com|
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center||Recruiting|
|San Francisco, California, United States, 94115|
|Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 firstname.lastname@example.org|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Clinical Trials Office 877-442-3324|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Nitya Raj, MD 646-888-4185 email@example.com|
|Principal Investigator:||Emily Bergsland, MD||University of California, San Francisco|