Lenvatinib Plus Pembrolizumab in Well Differentiated G3 Neuroendocrine Tumors
Status:
Not yet recruiting
Trial end date:
2027-07-31
Target enrollment:
Participant gender:
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).