Actively Recruiting
Neoadjuvant Lenvatinib and Pembrolizumab for IVC Tumor Thrombus
Led by University of Texas Southwestern Medical Center · Updated on 2025-08-22
30
Participants Needed
1
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant Lenvatinib and Pembrolizumab for IVC Tumor Thrombus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically confirmed clinical stage III-IV renal cell carcinoma with level II-IV inferior vena cava tumor thrombus
- Tumor and thrombus may be resectable or unresectable
- Male participants must agree to use contraception during treatment and for 90 days after
- Female participants must not be pregnant or breastfeeding and follow contraception guidelines if of childbearing potential
- Provide informed consent
- Measurable disease by RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Hepatitis B or C positive participants eligible if viral loads are controlled and therapy completed as specified
- HIV-positive participants eligible if well-controlled on ART with specified criteria
- Adequate organ function within 14 days before treatment start
You will not qualify if you...
- Women of childbearing potential with positive pregnancy test within 72 hours before allocation
- Prior therapy with anti-PD-1, anti-PD-L1, or similar agents
- Prior systemic anti-cancer therapy or investigational agents before allocation
- Radiotherapy within 2 weeks before study start unless palliative radiation with 1-week washout
- Live vaccine within 30 days before first dose of study drug
- Participation in other investigational studies within 4 weeks prior except specified imaging trial
- Immunodeficiency or recent immunosuppressive therapy above specified limits
- Active malignancy requiring treatment within past year except certain skin or in situ cancers
- Active central nervous system metastases or carcinomatous meningitis
- More than three metastatic RCC sites
- Severe hypersensitivity to pembrolizumab or lenvatinib
- Active autoimmune disease requiring recent systemic treatment
- History or current pneumonitis requiring steroids
- Active infection requiring systemic therapy
- Conditions or disorders interfering with study participation or safety
- Psychiatric or substance abuse disorders impacting cooperation
- Pregnant, breastfeeding, or planning conception during study and 120 days after last dose
- History of allogeneic tissue or solid organ transplant
- Prolonged QTcF interval >480 ms
- Left ventricular ejection fraction below local normal range with exceptions
- Significant cardiovascular disease within 12 months before first dose
- Proteinuria exceeding study limits
- Uncontrolled hypertension despite medication
- History of Kaposi's sarcoma or Multicentric Castleman's Disease in HIV-infected participants
- Active Hepatitis B or C infection with detectable viral load
- Hepatitis B and C screening as required by history or local authority
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
D
Donna Mitchell
CONTACT
D
Doreen Simonsen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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