OncoMatch/Clinical Trials/NCT05319015
Neoadjuvant Lenvatinib and Pembrolizumab for IVC Tumor Thrombus
Is NCT05319015 recruiting? Yes, currently enrolling (May 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
Cancer type
Renal Cell Carcinoma
Disease stage
Required: Stage CT3-4,N0-1,M0-1, CLINICAL STAGE III-IV (Mayo classification (for IVC tumor thrombus))
histologically confirmed cT3-4,N0-1,M0-1 (clinical stage III-IV) diagnosis of renal cell carcinoma (any subtype) with level II-IV inferior vena cava tumor thrombus as per the Mayo classification
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1 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.
Cannot have received: radiotherapy
Exception: A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
Has received prior radiotherapy within 2 weeks of start of study intervention.
Lab requirements
Blood counts
Adequate organ function as defined in Table 4 (details not provided in text)
Kidney function
Adequate organ function as defined in Table 4 (details not provided in text)
Liver function
Adequate organ function as defined in Table 4 (details not provided in text)
Cardiac function
LVEF must be above institutional normal range; LVEF ≥50% eligible; LVEF 40-49% eligible if no NYHA Class III/IV CHF; LVEF ≤39% not eligible; QTcF must not be >480 ms
Have adequate organ function as defined in the following table (Table 4)... Has prolongation of QTcF interval to >480 ms. Has a left ventricular ejection fraction (LVEF) below the institutional (or local laboratory) normal range, as determined by multigated acquisition (MUGA) or echocardiogram (ECHO).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Texas Southwestern Medical Center · Dallas, Texas
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