Lenvatinib Plus Pembrolizumab in Well Differentiated G3 Neuroendocrine Tumors (NCT05746208) | Clinical Trial Compass
RecruitingPhase 2
Lenvatinib Plus Pembrolizumab in Well Differentiated G3 Neuroendocrine Tumors
United States29 participantsStarted 2023-07-17
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participants must have locally advanced or unresectable histologically or cytologically confirmed WD G3 NET.
✓. pancreas primary.
✓. other primary sites:
✓. WD G3 NET occurring de novo or in the setting of grade progression allowed (provided WD G3 NET is thought to be the dominant histology at the time of enrollment).
✓. Tumors with ambiguous histology and/or Ki67 \>/=55% must be reviewed at the participating site to confirm that they are not poorly differentiated. Tumors with confirmed ambiguous histology will be considered eligible.
✓. At least 1 measurable target lesion according to RECIST 1.1, including the following criteria.
✓. non-nodal lesion that measures \>=1.0 cm in the longest diameter.
✓. lymph node (LN) lesion that measures as \>=1.5 cm in the short axis.
Exclusion criteria
✕. Has poorly differentiated neuroendocrine carcinoma (e.g., small cell NEC, large cell NEC, Merkel cell carcinoma, prostate neuroendocrine carcinoma) or WD Grades 1 or 2 NET (without evidence of G3 NET).
✕. Uncontrolled blood pressure (BP) (Systolic BP \>=140 mmHg or diastolic BP \>=90 mmHg) despite an optimized regimen of antihypertensive medication.
✕. Significant gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib.
✕. Has pre-existing \>= grade 3 (G3) gastrointestinal or non-gastrointestinal fistula.
✕. Has clinically significant cardiovascular disease within 12 months from the first dose of study intervention, including New York Heart Association (NYHA) Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability. Note: Medically controlled arrhythmia would be permitted
✕. Radiographic evidence of major blood vessel invasion/infiltration (e.g., carotid artery) or intratumoral cavitation in the chest (e.g. tumors above the diaphragm).
✕. Portal vein or inferior vena cava involvement by tumor is allowed at the discretion of the investigator (and is distinguished from invasion through the wall of a vessel.
✕. Vascular encasement by tumor below diaphragm is allowed at the discretion of the investigator, Examples of potentially eligible tumors include: mesenteric mass encasing superior mesenteric artery (SMA)/superior mesenteric vein (SMV), splenic vein involvement from a pancreas primary tumor, or lymphadenopathy adjacent to the inferior vena cava, portal vein, or other vessels without a clear plane between the tumor and vessel).