OncoMatch/Clinical Trials/NCT05319015
Neoadjuvant Lenvatinib and Pembrolizumab for IVC Tumor Thrombus
Official title: A Phase II Study of the Safety and Efficacy of Neoadjuvant Lenvatinib and Pembrolizumab in Patients With Renal Cell Carcinoma and IVC Tumor Thrombus
Is NCT05319015 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments including Neoadjuvant Lenvatinib and Neoadjuvant Pembrolizumab for renal cell carcinoma.
Treatment: Neoadjuvant Lenvatinib · Neoadjuvant Pembrolizumab · Adjuvant Pembrolizumab — This study will be evaluating safety and efficacy of the combination of lenvatinib and pembolizumab neoaadjuvant therapy prior to surgical resection of locally advanced renal cell carcinoma with IVC tumor thrombus.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Cancer type
Renal Cell Carcinoma
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy
Has received 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 (eg, CTLA-4, OX 40, CD137).
Cannot have received: systemic anti-cancer therapy
Has received prior systemic anti-cancer therapy including investigational agents prior to allocation.
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥1500/µL; Platelets ≥100,000/µL; Hemoglobin ≥9.0 g/dL (patients with microhematuria and Hb ≥8 who are asymptomatic may be considered eligible and must receive appropriate treatment for anemia to ensure Hb≥9 prior to starting treatment)
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
LVEF below institutional normal range is exclusion; LVEF ≥50% eligible; LVEF 40-49% eligible if no NYHA Class III/IV CHF; QTcF >480 ms excluded
Have adequate organ function as defined in the following table (Table 1)...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Texas Southwestern Medical Center · Dallas, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05319015 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy, systemic anti-cancer therapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage III or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages