Autologous Dendritic Cell Vaccine in Kidney Cancer (NCT05127824) | Clinical Trial Compass
RecruitingPhase 2
Autologous Dendritic Cell Vaccine in Kidney Cancer
United States42 participantsStarted 2023-07-06
Plain-language summary
The purpose of this study is to estimate the probability of immune response for the combination treatment of dendritic cell vaccine with oral cabozantinib and characterize the safety profile of interventional therapy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histologically proven clear cell renal cancer that is non-metastatic and amenable to surgical resection with no evidence of metastatic disease or lesions outside of the kidney.
. 18 years or older (male or female) with an ECOG performance status of 0 or 1.
. Have serotype HLA-A2+ if receiving vaccine.
. Capable of understanding and complying with the protocol requirements and have signed the informed consent document.
. Adequate organ and marrow function, based upon meeting all of the following laboratory criteria within 14 days before first dose of study treatment:
. Current (within the preceding 6 weeks) treatment with systemic immunosuppressive agents including steroids except when they are administered as replacement therapy for endocrine dysfunction and do not exceed 10 mg prednisone or equivalent daily.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Probability of immune response
Timeframe: Up to 48 months
2
Safety profile of interventional therapy - Adverse Events
Timeframe: Up to 48 months
3
Safety profile of interventional therapy - reduction in CD31+
. Active Hepatitis B or Hepatitis C infection or any other active infection requiring intravenous therapy.
. Blood transfusion within two weeks prior to leukapheresis.
. Prior treatment with cabozantinib.
. Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within two weeks before first dose of study treatment.
. Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within four weeks before first dose of study treatment.
. Radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.