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Neoadjuvant Lenvatinib and Pembrolizumab for IVC Tumor Thrombus

StatusRecruiting
PhasePhase 2
Started2023-01-06
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Jul 2026 → Dec 2026
See other at-risk trials from University of Texas Southwestern Medical Center

Amendment history

2026-09-17
Primary completion pushed: 2026-07 → 2026-12
Completion pushed: 2026-08 → 2026-12
2025-08-20
Study Status v9
Primary completion date2025-07→2026-07
Completion date2025-08→2026-08
2025-04-04
Study Identification, Study Status, Oversight, Eligibility v8
Eligibility criteria+3,463 characters
Inclusion Criteria: Male/female participants who are at least 18 years of age on the day of signing informed consent Have histologically confirmed cT3-4,N0-1,M0-1 (clinical sta [...] subtype) with level II-IV inferior vena cava tumor thrombus as per the Mayo classification of macroscopic venous invasion in renal cell carcinoma: Level 1 tumor thrombus is either at the entry of renal vein or within the IVC < 2 cm from the confluence of renal vein and IVC Level II tumor thrombus extends within the IVC > 2 cm above the confluence of renal v [...] The primary tumor and thrombus may be assessed to be resectable [...] [...]
2025-01-30
Study Identification, Study Status, Oversight v7
Primary completion date2024-12→2025-07
2024-11-01
Study Identification, Study Status, Oversight v6
Primary completion date2024-08→2024-12
Show 5 earlier versions
2024-02-16
Study Status v5
Re-verified, no change to tracked fields
2023-02-06
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-01→confirmed 2023-01-06
Study sites0→1
2022-12-23
Study Status v3
Start date2022-11→2023-01
2022-10-27
Study Status v2
Start date2022-08→2022-11
2022-06-28
Study Status v1
Primary completion date2024-05→2024-08
Completion date2025-05→2025-08
Start date2022-05→2022-08
2022-03-31
Original filing
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.
Trial Details
NCT Number NCT05319015
Lead Sponsor University of Texas Southwestern Medical Center
Conditions Renal Cell Carcinoma
Enrollment 30 participants
Start Date 2023-01-06
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-16