Actively Recruiting
Lenvatinib Plus Pembrolizumab in Well Differentiated G3 Neuroendocrine Tumors
Led by University of California, San Francisco · Updated on 2026-03-17
29
Participants Needed
1
Research Sites
245 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Lenvatinib Plus Pembrolizumab in Well Differentiated G3 Neuroendocrine Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have locally advanced or unresectable well-differentiated grade 3 neuroendocrine tumors confirmed by tissue analysis.
- Tumors may originate in the pancreas, gastrointestinal tract, lung, unknown primary site, or other non-pancreatic sites with Ki67 greater than 20%.
- Tumors may be newly diagnosed or result from progression of lower-grade tumors, with WD G3 NET as the dominant histology.
- At least one measurable tumor lesion of specified size must be present and suitable for repeated imaging.
- Progressive disease must be evident within 6 months unless first-line treatment is given for significant tumor burden or unfavorable biology.
- Participants must be 18 years of age or older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate bone marrow, liver, kidney, and coagulation function as defined by specific lab values.
- Ability and willingness to provide informed consent.
- Controlled blood pressure below 140/90 mmHg prior to treatment.
- Participants with prior or concurrent cancers that do not interfere with safety or efficacy assessments are eligible.
- Life expectancy greater than 3 months.
- Stage 2 participants must agree to biopsy of tumor tissue if safe and feasible.
- Male participants must agree to contraception or abstinence during and shortly after treatment.
- Female participants must not be pregnant or breastfeeding and must use effective contraception if of childbearing potential.
You will not qualify if you...
- Poorly differentiated neuroendocrine carcinoma or lower grade NET without evidence of G3 NET.
- Uncontrolled blood pressure equal to or above 140/90 mmHg despite treatment.
- Significant gastrointestinal malabsorption affecting lenvatinib absorption.
- Presence of grade 3 or higher gastrointestinal or non-gastrointestinal fistula.
- Serious cardiovascular disease within 12 months prior to treatment including severe heart failure or unstable angina.
- Major blood vessel invasion or tumor cavitation above the diaphragm, with some exceptions below the diaphragm.
- Active bleeding from tumor or airways within 3 weeks before treatment.
- Severe allergic reaction or intolerance to study drugs or their components.
- Non-healing wounds, ulcers, or bone fractures.
- Bleeding or clotting disorders or high risk for severe bleeding.
- Immunodeficiency or recent systemic immunosuppressive therapy.
- Active central nervous system metastases or carcinomatous meningitis unless stable and treated.
- Active autoimmune disease requiring recent systemic treatment.
- History of pneumonitis needing steroids or current pneumonitis.
- Active infection needing systemic therapy.
- Known HIV infection.
- Active hepatitis B or C infection unless controlled.
- Active tuberculosis infection.
- High proteinuria or abnormal heart function by tests.
- Pregnant or breastfeeding women.
- Conditions or treatments that would interfere with study participation or safety.
- Psychiatric or substance abuse issues interfering with study compliance.
- Recent participation in other investigational studies or recent cancer treatments.
- Prior treatment with lenvatinib or certain immunotherapies.
- Recent radiotherapy or major surgery without adequate recovery.
- Organ transplant recipients.
- Use of medications that prolong QT interval without possibility of discontinuation.
- Recent use of live vaccines or certain biologic therapies.
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
J
Jennifer Luan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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