OncoMatch/Clinical Trials/NCT05746208
Lenvatinib Plus Pembrolizumab in Well Differentiated G3 Neuroendocrine Tumors
Is NCT05746208 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Lenvatinib and Pembrolizumab for neuroendocrine tumors.
Treatment: Lenvatinib · Pembrolizumab · Hyperpolarized 13C-Pyruvate — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroendocrine Tumor
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: lenvatinib (lenvatinib)
Has received prior treatment with lenvatinib
Cannot have received: anti-PD-1 therapy (pembrolizumab)
Has received prior treatment with any anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX 40, CD137)
Cannot have received: anti-PD-L1 therapy
Has received prior treatment with any anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX 40, CD137)
Cannot have received: anti-PD-L2 therapy
Has received prior treatment with any anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX 40, CD137)
Cannot have received: CTLA-4 inhibitor
Has received prior treatment with any anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX 40, CD137)
Lab requirements
Blood counts
Absolute neutrophil count ≥1,500/mcL; Platelets ≥100,000/mcL; Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L.
Kidney function
Creatinine ≤ 1.5 x institutional upper limit of normal OR Creatinine clearance ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN. Urine protein-to-creatinine ratio (UPCR) <1 (unless urine protein <1 g/24 hour) OR Urine protein dipstick ≤ 1+ (unless urine protein <1 g/24 hour).
Liver function
Total bilirubin ≤1.5 X institutional upper limit of normal, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits. AST and ALT ≤2.5 X ULN (≤5 × ULN for participants with liver metastases).
Cardiac function
QTc interval ≤ 480 ms; LVEF within institutional normal range.
Adequate organ function as defined below (Specimens must be collected within 14 days prior to the start of study treatment): ... see full criteria for details.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California, San Francisco · San Francisco, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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