A Phase II Study of Lenvatinib Plus Pembrolizumab in Well Differentiated G3 Neuroendocrine Tumors
University of California, San Francisco
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).
Description
PRIMARY OBJECTIVE: I. To evaluate the overall response rate (ORR) of lenvatinib plus pembrolizumab. SECONDARY OBJECTIVES: I. To determine the safety and tolerability of lenvatinib plus pembrolizumab. II. To evaluate the duration of response (DOR) in patients receiving lenvatinib plus pembrolizumab. III. To evaluate progression-free survival (PFS) in patients receiving lenvatinib plus pembrolizumab. EXPLORATORY OBJECTIVES: I. To evaluate overall survival (OS) in participants receiving lenvatinib plus pembrolizumab. II. To compare overall response rate (ORR), DOR, and PFS by Immune-relat…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participants must have locally advanced or unresectable histologically or cytologically confirmed WD G3 NET. 1. pancreas primary. 2. other primary sites: * gastrointestinal site, * unknown primary site, * lung neuroendocrine carcinoma with carcinoid morphology, or * other non-pancreatic primary sites with well-differentiated (WD) morphology and Ki67 \> 20%. 3. 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). 4. Tumors wi…
Interventions
- DrugLenvatinib
Given orally
- DrugPembrolizumab
Given IV
- DrugHyperpolarized 13C-Pyruvate
Given IV
Location
- University of California, San FranciscoSan Francisco, California