Second-Line Treatment Landscape for Renal Cell Carcinoma: A Comprehensive Review.
Nizar M Tannir, Sumanta K Pal, Michael B Atkins
https://pubmed.ncbi.nlm.nih.gov/29487224Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID05127824
A Phase 2a Study of Autologous Dendritic Cell Vaccines with Cabozantinib in Patients with Localized Clear Cell Renal Cancer
Led by Jodi Maranchie · Updated on 2025-05-04
42
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates the immune response and safety of combining a dendritic cell vaccine with oral cabozantinib in patients who have been newly diagnosed with localized clear cell renal cell carcinoma (ccRCC) and are planning surgical removal of their kidney tumor. The study aims to understand how this combination treatment influences the tumor's blood vessels and immune cell activity. It is a phase 2a trial focusing on patients without metastatic disease. Participants who are eligible and choose to undergo surgery will receive two doses of an autologous Tumor Blood Vessel Antigen (TBVA) dendritic cell vaccine injected into the skin every two weeks before surgery, along with oral cabozantinib taken daily for 10 days leading up to the surgery. Those who are HLA-A2 positive will receive the vaccine and drug combination, while HLA-A2 negative participants will be enrolled as non-treatment controls without undergoing study procedures. During the study, participants will have their tumors examined for vascular and immune changes, and safety will be closely monitored through blood tests and adverse event tracking for up to 48 months. Outcomes include measuring the immune response probability, changes in tumor blood vessels, and treatment safety. Participants will be followed through surgery and beyond to assess long-term effects and markers of vascular normalization.
CONDITIONS
Brief Title
Autologous Dendritic Cell Vaccine in Kidney Cancer
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Histologically confirmed clear cell renal cancer that is localized and suitable for surgical removal with no metastatic disease.
- Age 18 years or older with an ECOG performance status of 0 or 1.
- HLA-A2 positive serotype if receiving the vaccine.
- Ability to understand and comply with the study requirements and provide informed consent.
- Adequate organ and marrow function based on specific laboratory tests within 14 days before treatment.
- Agreement to use medically accepted contraception methods during the study and for 4 months after treatment.
- Female participants of childbearing potential must not be pregnant and must meet specific menopause or sterilization criteria.
You will not qualify if you...
- Treatment with systemic immunosuppressive agents within 6 weeks prior, except certain low-dose steroids.
- Evidence or suspicion of metastatic disease.
- Active infections like Hepatitis B or C requiring intravenous therapy.
- Blood transfusion within 2 weeks before leukapheresis.
- Previous treatment with cabozantinib or recent use of kinase inhibitors or systemic anticancer therapies.
- Recent radiation therapy within specified timeframes before treatment.
- Use of certain anticoagulants, with some exceptions for stable doses.
- Abnormal blood clotting test results before treatment.
- Uncontrolled or significant illnesses including serious heart conditions, uncontrolled hypertension, recent strokes or blood clots.
- Gastrointestinal disorders such as active ulcers, fistulas, or recent abdominal complications.
- Significant bleeding events within 12 weeks prior.
- Pulmonary lesions or disease affecting major blood vessels.
- Other significant disorders that may affect safety or participation.
- Recent major or minor surgery without complete healing.
- Prolonged QT interval on ECG.
- Pregnancy or lactation.
- Inability to swallow tablets.
- Known allergies to study treatments.
- Other active cancers requiring treatment, with some exceptions.
- Any conditions deemed unsafe by the treating physician.
AI-Screening
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1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Run-in Period
Duration - Approximately 31 days before surgery
Participants receive neoadjuvant autologous Tumor Blood Vessel Antigen (TBVA)-Dendritic Cell Vaccine intradermally every 2 weeks twice, along with oral cabozantinib 20 mg daily for 10 days before surgery.
2 vaccine visits and daily oral medication for 10 days
Surgery
Duration - 1 day
Participants undergo surgical resection of the localized clear cell renal cell carcinoma.
1 surgical visit (in-person)
Follow-up
Duration - Up to 48 months
Participants are monitored for safety and immune response after treatment.
Visits scheduled according to study protocol
Trial Site Locations
Total: 1 location
1
UPMC Department of Urology
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
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Research Team
M
Morgan Pokora, RN
J
Jodi Maranchie, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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