Lenvatinib Plus Pembrolizumab in Well Differentiated G3 Neuroendocrine Tumors

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT05746208
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lenvatinib — DRUG
    Given orally
  • Pembrolizumab — DRUG
    Given IV
  • Hyperpolarized 13C-Pyruvate — DRUG
    Given IV

Study Details

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).

Key Dates

Start date
Jul 17, 2023
Status verified
Mar 2026
Primary completion
Jan 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
29 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Lenvatinib Plus Pembrolizumab
    Participants will receive 20 mg once daily of lenvatinib plus 400 mg of pembrolizumab every 6 weeks for up to 18 doses. Eligible participants may also receive a Hyperpolarized 13C-pyruvate (HP 13C) magnetic resonance imaging (MRI) scan

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Up to 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Jennifer Luan
[email protected]
(415) 514-6220
[email protected]
Emily Bergsland, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By condition
Neuroendocrine tumors
By specialty
Oncology
By research site
University of California, San Francisco· San Francisco, CA

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