Clinical Trial: Study of Pembrolizumab With Lanreotide Depot for Gastroenteropancreatic Neuroendocrine Tumors
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Phase Ib/II Study of Pembrolizumab With Lanreotide Depot for Gastroenteropancreatic Neuroendocrine Tumors
Brief Summary:
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.
Detailed Summary:
Sponsor: Duke University
Current Primary Outcome: 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 restaging through study completion (approximately 48 weeks) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Treatment-related adverse events [ Time Frame: Continuous, at minimum every 3 weeks until study completion (approximately 48 weeks) ]
- 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 ]
- 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 ]
- 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 (approximately 48 weeks) ]
Original Secondary Outcome: Same as current
Information By: Duke University
Dates:
Date Received: February 1, 2017
Date Started: May 1, 2017
Date Completion: June 1, 2021
Last Updated: February 2, 2017
Last Verified: February 2017