At a glance
ClinicalIndex Comparison Record- ✓Non-resectable, recurrent, or metastatic well- or moderately-differentiated GEP-NETs with disease progression within the last 12 months
- ✓At least one measurable lesion by RECIST version 1.1
- ✓Prior somatostatin analogue therapy (first study drug dose no sooner than 4 weeks after last somatostatin analogue dose)
- ✓Age ≥18 years
- ✕High-grade tumor: mitotic rate >20/10 hpf and/or Ki67 index >20%
- ✕Prior anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
- ✕Prior anti-cancer monoclonal antibody within 4 weeks prior to first dose or inadequate recovery from prior adverse events
- ✕Prior chemotherapy, targeted therapy, or radiation within 2 weeks prior to first dose or inadequate recovery (Grade 2 neuropathy allowed)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase Ib/II Study of Pembrolizumab With Lanreotide Depot for Gastroenteropancreatic Neuroendocrine Tumors
In Brief
A Phase 2 clinical trial evaluating Lanreotide and Pembrolizumab for Gastroenteropancreatic Neuroendocrine Tumors. Completed, enrolled 22 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
Somatuline depot (lanreotide) 90 mg SQ every 3 weeks
Keytruda (pembrolizumab) 200 mg IV every 3 weeks