Study of Pembrolizumab With Lanreotide Depot for Gastroenteropancreatic Neuroendocrine Tumors

What Was Tested

This registered phase 1, phase 2 trial tested Lanreotide.

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.

It had 1 arm (groups): Arm 1 (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 22 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Willing and able to provide written informed consent for the trial. At least 18 years of age on day of signing informed consent. At least one measurable lesion based on RECIST version 1.1. ECOG performance status of 0 or 1. Adequate organ function defined as:.

The full record lists 18 inclusion and 21 exclusion criteria; among the exclusions: known history of active tb (bacillus tuberculosis); hypersensitivity to pembrolizumab or lanreotide or any of their excipients; known history of, or any evidence of active, non-infectious pneumonitis.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Lanreotide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2017-07-01 with completion listed for 2021-05-03.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Objective Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) (time frame: Approximately every 12 weeks until study completion (up to 2 years)).

It also tracked 4 secondary outcomes, for example Number of Participants Experiencing Treatment-related AEs Leading to Drug Discontinuations During the First 12 Weeks of Treatment, Months of Progression-free Survival (PFS), Months of Overall Survival (OS) and ORR as Measured by Immune-related Response Criteria (irRC).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of Lanreotide in 22 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Lanreotide compound page, all human trials.