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Lenvatinib Plus Pembrolizumab in Well Differentiated G3 Neuroendocrine Tumors

NCT05746208 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2026-03-17

No results posted yet for this study

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).

Conditions

  • Neuroendocrine Tumors
  • Well-Differentiated Neuroendocrine Carcinoma
  • High Grade Neuroendocrine Carcinoma, Any Site

Interventions

DRUG

Lenvatinib

Given orally

DRUG

Pembrolizumab

Given IV

DRUG

Hyperpolarized 13C-Pyruvate

Given IV

Sponsors & Collaborators

Principal Investigators

  • Emily Bergsland, MD · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-17
Primary Completion
2028-01-31
Completion
2028-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05746208 on ClinicalTrials.gov