Study of Pembrolizumab With Lanreotide Depot for Gastroenteropancreatic Neuroendocrine Tumors (PLANET)
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|ClinicalTrials.gov Identifier: NCT03043664|
Recruitment Status : Recruiting
First Posted : February 6, 2017
Last Update Posted : June 13, 2018
This study is for patients with non-resectable, recurrent, or metastatic well or moderately differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
The study will be conducted in two stages: 1) Safety Run-In and 2) Expanded Cohort.
- Safety run-in: The first stage will include a safety run-in of 6 patients treated with pembrolizumab 200 mg intravenous (IV) every 3 weeks and lanreotide depot 90mg subcutaneous (SQ) every 3 weeks. Up to 6 patients at the Duke Cancer Institute will be accrued at the starting dose level. If one or less subject meets treatment-related discontinuation criteria (as specified in the protocol) during Cycle 1, then the study will proceed to the second stage, Expanded Cohort.
- Expanded Cohort: Patients will be treated with pembrolizumab 200mg IV every 3 weeks and lanreotide depot 90mg SQ every 3 weeks as determined by the Safety Run-In Cohort.
|Condition or disease||Intervention/treatment||Phase|
|Gastroenteropancreatic Neuroendocrine Tumors||Drug: Somatuline Depot Drug: Keytruda||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Pembrolizumab 200mg IV every 3 weeks and lanreotide depot 90mg SQ every 3 weeks|
|Masking:||None (Open Label)|
|Official Title:||Phase Ib/II Study of Pembrolizumab With Lanreotide Depot for Gastroenteropancreatic Neuroendocrine Tumors|
|Actual Study Start Date :||July 1, 2017|
|Estimated Primary Completion Date :||June 1, 2020|
|Estimated Study Completion Date :||June 1, 2020|
Experimental: Arm 1
Keytruda (pembrolizumab) 200 mg intravenous (IV) every 3 weeks and Somatuline Depot (lanreotide depot) 90mg subcutaneous (SQ) every 3 weeks
Drug: Somatuline Depot
Somatuline depot (Lanreotide depot) 90mg SQ every 3 weeks
Keytruda (pembrolizumab) 200mg IV every 3 weeks
- Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 [ Time Frame: Approximately every 12 weeks and/or re-staging through study completion (up to 2 years) ]
- Treatment-related adverse events [ Time Frame: Continuous, at minimum every 3 weeks until study completion (up to 2 years) ]
- Progression free survival (PFS) of pembrolizumab in combination with lanreotide depot in subjects with GEP-NETs. [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause (whichever is first); assessed up to 48 weeks after the last subject enrolled ]
- Overall survival (OS) of pembrolizumab in combination with lanreotide depot in subjects with GEP-NETs. [ Time Frame: From date of randomization until the date of death from any cause; assessed up to 48 weeks after the last subject enrolled ]
- ORR by Immune-Related Response Criteria (irRC) to pembrolizumab in combination with lanreotide depot in subjects with progressive, advanced or metastatic GEP-NETs. [ Time Frame: Approximately every 12 weeks and/or restaging until study completion (up to 2 years) ]
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): NCT03043664
|Contact: Christy Arrowoodfirstname.lastname@example.org|
|Contact: Anthony Amara, MSWemail@example.com|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Michael Morse, MD||Duke University|