Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Emily Bergsland, MD (ucsf)
Headshot of Emily Bergsland
Emily Bergsland

Description

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).

Official Title

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

Details

Keywords

Neuroendocrine Tumors, Well-Differentiated Neuroendocrine Carcinoma, High Grade Neuroendocrine Carcinoma, Any Site, Carcinoma, Neuroendocrine Carcinoma, Pembrolizumab, Lenvatinib, Hyperpolarized 13C-Pyruvate, Lenvatinib Plus Pembrolizumab

Eligibility

Location

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States

Lead Scientist at University of California Health

  • Emily Bergsland, MD (ucsf)
    Emily Bergsland, MD is a medical oncologist at the University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center who specializes in gastrointestinal malignancies. She is a Professor of Medicine, Director of the UCSF Center for Neuroendocrine Tumors, and serves as Associate Director for Education for the UCSF Helen Diller Family Comprehensive Cancer Center.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05746208
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 29 study participants
Last Updated