OncoMatch/Clinical Trials/NCT04887805
Lenvatinib and Pembrolizumab Maintenance Therapy for the Treatment of Patients of Advanced Unresectable Pancreatic Cancer
Is NCT04887805 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and Lenvatinib Mesylate for advanced pancreatic ductal adenocarcinoma.
Treatment: Lenvatinib Mesylate · Pembrolizumab — This phase II trial studies the effects of lenvatinib and pembrolizumab maintenance therapy in treating patients with pancreatic cancer that has spread to other places in the body (advanced) and cannot be removed by surgery (unresectable). Lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lenvatinib and pembrolizumab may be effective as a maintenance therapy in patients with pancreatic cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Disease stage
Required: Stage II, IIA, IIB, III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy — 1st or 2nd line
Must have received at least 16 weeks of 1st or 2nd line therapy and achieved partial response or stable disease (by CT or MRI) with no signs of progression within 30 days before start of treatment
Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy
No prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137)
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L (without erythropoietin dependency and without pRBC transfusion within last 2 weeks); ANC ≥ 1,500/mm^3; Platelets ≥ 100,000/mm^3
Kidney function
Creatinine ≤ 1.5 x ULN OR calculated creatinine clearance ≥ 30 mL/min for participant with creatinine levels >1.5 x institutional ULN
Liver function
Total serum bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels > 1.5 x ULN; AST ≤ 1.5 x ULN or ≤ 3 x ULN with liver metastases; ALT ≤ 1.5 x ULN or ≤ 3 x ULN with liver metastases
Cardiac function
Significant cardiovascular impairment: history of congestive heart failure greater than NYHA Class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug, or cardiac arrhythmia requiring medical treatment at Screening [excluded]
Hemoglobin ≥ 9.0 g/dL...; ANC ≥ 1,500/mm^3; Platelets ≥ 100,000/mm^3; Total serum bilirubin ≤ 1.5 x ULN...; AST ≤ 1.5 x ULN or ≤ 3 x ULN with liver metastases; ALT ≤ 1.5 x ULN or ≤ 3 x ULN with liver metastases; Creatinine ≤ 1.5 x ULN OR calculated creatinine clearance ≥ 30 mL/min...; INR or PT ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy...; aPTT ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy...; Significant cardiovascular impairment: history of congestive heart failure greater than NYHA Class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug, or cardiac arrhythmia requiring medical treatment at Screening [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
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