Pembrolizumab With Chemotherapy in Metastatic or Unresectable High Grade Gastroenteropancreatic or Lung Neuroendocrine Carcinoma
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|ClinicalTrials.gov Identifier: NCT03901378|
Recruitment Status : Not yet recruiting
First Posted : April 3, 2019
Last Update Posted : April 5, 2019
|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)|
|Estimated Enrollment :||36 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|
|Estimated Study Start Date :||April 2019|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||December 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
|Contact: Sarah Nowakemail@example.com|
|United States, Louisiana|
|Ochsner Clinic Foundation||Not yet recruiting|
|New Orleans, Louisiana, United States, 70121|
|Contact: Robert Ramriez, DO firstname.lastname@example.org|
|Contact: Sharon Jerdonek, RN email@example.com|
|Principal Investigator:||Robert Ramirez, DO||Ochsneer Clinic Foudnation|