RecruitingPhase 2NCT05746208

Lenvatinib Plus Pembrolizumab in Well Differentiated G3 Neuroendocrine Tumors

A Phase II Study of Lenvatinib Plus Pembrolizumab in Well Differentiated G3 Neuroendocrine Tumors


Sponsor

University of California, San Francisco

Enrollment

29 participants

Start Date

Jul 17, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is the first study to be done in a newly described class of neuroendocrine tumors known as well-differentiated grade 3 neuroendocrine tumors (WD G3 NET). First described in the pancreas in 2017, the classification was broadened to include gastrointestinal tract tumors in 2019. Recent data suggest an equivalent subtype exists in the lungs (NEC with carcinoid morphology). WD G3 NETs can occur de novo as well as the result of grade progression over time. This is a single arm, multi-site, Phase II study in biomarker "unselected" participants. This study will also incorporate serial blood samples, tumor biopsies, and special imaging to better understand the impact of therapy on the tumor and microenvironment. Hyperpolarized (HP) 13C-pyruvate magnetic resonance imaging (MRI) - a novel non-radioactive imaging modality able to provide in vivo measurements of the pyruvate-to-lactate conversion rate (kpl).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Hyperpolarized 13C-Pyruvate, a drug called Lenvatinib, and others for people with high grade neuroendocrine carcinoma, any site, neuroendocrine tumors, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLenvatinib

Given orally

DRUGPembrolizumab

Given IV

DRUGHyperpolarized 13C-Pyruvate

Given IV


Locations(1)

University of California, San Francisco

San Francisco, California, United States

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NCT05746208


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