Date: 2017-02-01
Type of information: Initiation of the trial
phase: 1-2
Announcement: initiation of the trial
Company: Duke University (USA - NC) Merck&Co (USA - NJ) Ipsen (France)
Product: pembrolizumab and Lanreotide Depot
Action
mechanism: immunotherapy product/monoclonal antibody/immune checkpoint inhibitor/peptide. Keytruda® (pembrolizumab - MK-3475) is a monoclonal anti-PD-1 antibody designed to restore the natural ability of the immune system to recognize and target cancer cells by selectively achieving dual ligand blockade (PD-L1 and PD-L2) of the PD-1 protein. By blocking PD-1, pembrolizumab enables activation of the immune system’s T-cells that target cancer by essentially releasing a brake on the immune system. Lanreotide is a synthetic octapeptide analogue of somatostatin, an endogenous peptide present in several areas of the central nervous system and gastrointestinal tract.
Disease: gastroenteropancreatic neuroendocrine tumors
Therapeutic area: Cancer - Oncology
Country:
Trial
details: PLANET is a phase 1-2 study 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. (NCT03043664)
Latest
news: * On February 1, 2017, a Phase 1-2 trial sponsored by Duke University was published on the NIH website ClinicalTrials.gov for pembrolizumab and Lanreotide Depot.
