OncoMatch/Clinical Trials/NCT04865887
Pembrolizumab and Lenvatinib in Advanced Cervical Cancer
Is NCT04865887 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and Lenvatinib for cervical cancer.
Treatment: Pembrolizumab · Lenvatinib — This is a phase II trial of combination therapy of pembrolizumab and lenvatinib in patients with locally advanced or metastatic cervical cancer that had failed first line of therapy. The hypothesis is the combination of lenvatinib and pembrolizumab will overcome vascular endothelial growth factor (VEGF)-mediated immunosuppression to enhance the response of patients with locally advanced or metastatic cervical cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cervical Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy — locally advanced or metastatic
Patients with progression or intolerance to at least one line of therapy in the locally advanced or metastatic setting
Cannot have received: anti-PD-1 therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent.
Cannot have received: systemic anti-cancer therapy
Exception: within 4 weeks
Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks
Cannot have received: radiotherapy
Exception: within 2 weeks of start of study treatment; 1-week washout permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease
Has received prior radiotherapy within 2 weeks of start of study treatment. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease.
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥1500/µL; Platelets ≥100,000/µL; Hemoglobin ≥9.0 g/dL
Kidney function
Creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN
Liver function
Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN; AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)
Cardiac function
International normalized ratio (INR) OR prothrombin time (PT), Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants; Prolongation of QTc interval to >480 ms [excluded]
Have adequate organ function as defined. ... Absolute neutrophil count (ANC) ≥1500/µL; Platelets ≥100 000/µL; Hemoglobin ≥9.0 g/dL; Creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN; Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN; AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases); International normalized ratio (INR) OR prothrombin time (PT), Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants; Prolongation of QTc interval to >480 ms [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- MedStar Georgetown University Hospital · Washington D.C., District of Columbia
- Medstar Washington Hospital Center · Washington D.C., District of Columbia
- Georgia Cancer Center at Augusta University · Augusta, Georgia
- John Theurer Cancer Center at Hackensack UMC · Hackensack, New Jersey
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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