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Lanreotide

Phase 1

Gastroenteropancreatic Neuroendocrine Tumors | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Jun 29, 2023

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment22

FDA Designations

No designations recorded

Clinical trial landscape

Lanreotide · 1 trial · 1 indication

Phase 1 1
NCT03043664Study of Pembrolizumab With Lanreotide Depot for Gastroenteropancreatic Neuroendocrine TumorsGastroenteropancreatic Neuroendocrine Tumors
COMPLETED22 Analytics
PHASE1COMPLETED
Study of Pembrolizumab With Lanreotide Depot for Gastroenteropancreatic Neuroendocrine Tumors
Gastroenteropancreatic Neuroendocrine TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Objective Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Approximately every 12 weeks until study completion (up to 2 years)

ORR is calculated as the number of people with a complete response (CR) or partial response (PR), divided by the total number of people treated. Complete response is defined as disappearance of all target lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. A lower limit of the true ORR will be estimated by the 90% exact lower confidence bound (LCB) for the binomial proportion. A 90% LCB of \< 0.1 will be considered not to be of clinical value. If the 90% LCB is ≥ 0.1, the regimen will be considered efficacious.

Secondary Endpoints

Number of Participants Experiencing Treatment-related AEs Leading to Drug Discontinuations During the First 12 Weeks of Treatment
First 12 weeks of treatment
Months of Progression-free Survival (PFS)
Up to 3 years
Months of Overall Survival (OS)
Up to 59 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTALKeytruda (pembrolizumab) 200 mg intravenous (IV) infusion every 3 weeks and Somatuline Depot (lanreotide) 90 mg subcutaneous (SQ) injection every 3 weeks.

Interventions

NameTypeDescription
LanreotideDRUGSomatuline depot (lanreotide) 90 mg SQ every 3 weeks
PembrolizumabDRUGKeytruda (pembrolizumab) 200 mg IV every 3 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Willing and able to provide written informed consent for the trial. 2. At least 18 years of age on day of signing informed consent. 3. Non-resectable, recurrent, or metastatic well- or moderately-differentiated gastroenteropancreatic neuroendocrine tumor (GEP-NETs) with disea...

Countries:United States
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Frequently asked questions about Lanreotide

What is Lanreotide used for in Gastroenteropancreatic Neuroendocrine Tumors?

Lanreotide is being studied for use in gastroenteropancreatic neuroendocrine tumors, a type of cancer that arises in the digestive system. It is currently in Phase 1 clinical development as an investigational therapy for this condition. The drug is being evaluated in combination with pembrolizumab in a clinical trial.

Who makes Lanreotide?

Lanreotide is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical research on this drug for the treatment of gastroenteropancreatic neuroendocrine tumors. Merck is responsible for the ongoing development and clinical testing of Lanreotide.

What phase is Lanreotide in?

Lanreotide is in Phase 1 clinical development for gastroenteropancreatic neuroendocrine tumors. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains under investigation for this indication.

What clinical trials is Lanreotide in?

Lanreotide has been studied in one clinical trial with the identifier NCT03043664. This Phase 1 trial, titled "Study of Pembrolizumab With Lanreotide Depot for Gastroenteropancreatic Neuroendocrine Tumors," was completed in the United States. The trial enrolled 22 participants aged 18 years and older.

Does Lanreotide target a specific biomarker?

Lanreotide is being studied in a biomarker-selected patient population for gastroenteropancreatic neuroendocrine tumors. The clinical trial evaluating Lanreotide used biomarker selection to identify eligible participants. This approach aims to match the drug to patients who may be more likely to respond based on specific biological markers.

Is Lanreotide the same as a depot formulation?

Lanreotide is being studied as a depot formulation, as indicated in the clinical trial title "Study of Pembrolizumab With Lanreotide Depot for Gastroenteropancreatic Neuroendocrine Tumors." The depot formulation is designed for sustained release of the drug over time. This formulation was used in the Phase 1 trial for this indication.