NCT03043664

Study of Pembrolizumab With Lanreotide Depot for Gastroenteropancreatic Neuroendocrine Tumors

Phase Ib/II Study of Pembrolizumab With Lanreotide Depot for Gastroenteropancreatic Neuroendocrine Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 1. 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. 2. 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.

Conditions

• Gastroenteropancreatic Neuroendocrine Tumors

Interventions

Type	Name	Description
DRUG	Lanreotide	Somatuline depot (lanreotide) 90 mg SQ every 3 weeks
DRUG	Pembrolizumab	Keytruda (pembrolizumab) 200 mg IV every 3 weeks

Timeline

• Start date: 2017-07-01
• Primary completion: 2021-05-03
• Completion: 2022-06-07
• First posted: 2017-02-06
• Last updated: 2023-06-29
• Results posted: 2022-09-28

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study