Study on Lenvatinib and Pembrolizumab for Well-Differentiated Grade 3 Neuroendocrine Tumors

Sponsor: University of California, San Francisco

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05746208

Provider View

This clinical trial is exploring a new treatment using the drugs Lenvatinib and Pembrolizumab for patients with a specific type of neuroendocrine tumor called well-differentiated grade 3 (WD G3) neuroendocrine tumors. The study aims to understand how these drugs affect the tumor and the surrounding environment.

Patient Parameters

Program Overview

This study is the first to focus on a newly identified type of neuroendocrine tumor known as well-differentiated grade 3 (WD G3) neuroendocrine tumors. These tumors can occur in the pancreas, gastrointestinal tract, and possibly the lungs. The trial will test the combination of two drugs, Lenvatinib and Pembrolizumab, to see if they can effectively treat these tumors. Participants will undergo various tests, including blood samples, tumor biopsies, and special imaging, to understand the treatment's impact on the tumor and its environment. The study will also use a new type of MRI scan to measure certain chemical changes in the tumor.

Description

The main goal of this study is to see how well the combination of Lenvatinib and Pembrolizumab works in treating well-differentiated grade 3 neuroendocrine tumors. Researchers will also look at how safe and tolerable the treatment is for patients, how long the treatment effects last, and how it impacts patients' survival without the disease getting worse.

The study will involve two stages. If the first stage shows positive results, more participants will be enrolled in the second stage. Participants can continue the treatment for up to two years. After treatment ends, participants will be monitored for any side effects and their overall health. If the disease progresses, participants will be followed up by phone to track their survival and any further cancer treatments.

The study will also explore various scientific questions, such as how the treatment affects immune cells in the tumor, how the tumor's growth rate changes, and how these factors relate to treatment outcomes. Special imaging techniques will be used to study the tumor's metabolism and growth patterns.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of well-differentiated grade 3 neuroendocrine tumors (WD G3 NET) that cannot be surgically removed.
  • Tumors can originate from the pancreas, gastrointestinal tract, lungs, or other sites with specific characteristics.
  • Have at least one measurable tumor that can be tracked using scans.
  • Show evidence of disease progression within the last 6 months, unless there is significant liver involvement or high tumor growth rate.
  • Have tried at least one previous treatment if the tumor growth rate is below a certain level.
  • Be 18 years or older.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate organ function as determined by specific blood tests.
  • Agree to provide a tumor sample for analysis.
  • Have controlled blood pressure.
  • Have a life expectancy of more than 3 months.
  • Agree to use effective contraception if of childbearing potential.

Exclusion Criteria

  • Have poorly differentiated neuroendocrine carcinoma or other types of neuroendocrine tumors not classified as WD G3 NET.
  • Have uncontrolled high blood pressure.
  • Have significant digestive issues that affect drug absorption.
  • Have serious heart conditions or recent heart attacks.
  • Have active bleeding or blood clotting disorders.
  • Have active infections or autoimmune diseases requiring treatment.
  • Have known brain metastases unless stable and not requiring treatment.
  • Have a history of severe allergic reactions to the study drugs.
  • Be pregnant or breastfeeding.
  • Have participated in another clinical trial or received certain treatments recently.
  • Have received live vaccines recently.

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