Pembrolizumab With Chemotherapy in Metastatic or Unresectable High Grade Gastroenteropancreatic or Lung Neuroendocrine Carcinoma
|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: NCT03901378|
Recruitment Status : Withdrawn (Lack of accrual)
First Posted : April 3, 2019
Last Update Posted : January 25, 2021
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Carcinoma Large Cell Neuroendocrine Carcinoma of the Lung High Grade Neuroendocrine Carcinoma, Any Site||Drug: Pembrolizumab||Phase 2|
Combination chemotherapy is the mainstay of treatment for patients with high grade GEPNETs and neuroendocrine carcinomas of the lung.
This study will utilize pembrolizumab, a potent humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb) with high specificity of binding to the programmed cell death 1 (PD-1) receptor, thus blocks a protective mechanism of cancer cells and thereby allows the immune system to destroy them, in combination with chemotherapy.
Combination chemotherapy and pembrolizumab was recently FDA approved and ongoing trials are utilizing this or similar combination with preliminary data demonstrating a promising safety profile.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Pembrolizumab in Combination With Cisplatin or Carboplatin and Etoposide in Chemotherapy naïve Patients With Metastatic or Unresectable High Grade Gastroenteropancreatic or Lung (Excluding Small Cell) Neuroendocrine Carcinoma|
|Actual Study Start Date :||October 2, 2019|
|Actual Primary Completion Date :||January 21, 2021|
|Actual Study Completion Date :||January 21, 2021|
Experimental: Single Arm
Pembrolizumab 200mg IV day 1 with Carboplatin AUC 6 IV day 1 or Cisplatin 80mg/m2 day 1 with etoposide 100mg/m2 days 1-3 of 21 day cycle. Repeat 4-6 cycles to be followed by maintenance Pembrolizumab 200mg IV day 1 every 21 days until progression or intolerance for up to 2 years.
Intravenous administration of pembrolizumab in combination with cisplatin or carboplatin and etoposide in first line metastatic or unresectable high grade neuroendocrine carcinoma:
- Progression Free Survival [ Time Frame: 1 year ]Assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Combination therapy will be safe and tolerable compared to historical controls [ Time Frame: Continuous from the signing of the informed consent to 28 days after last study treatment ]Collection of any adverse event
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): NCT03901378
|United States, Louisiana|
|Ochsner Clinic Foundation|
|Kenner, Louisiana, United States, 70065|
|Ochsner Clinic Foundation|
|New Orleans, Louisiana, United States, 70121|
|Principal Investigator:||Robert Ramirez, DO||Ochsneer Clinic Foudnation|