Autologous Dendritic Cell Vaccine in Kidney Cancer

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Jodi Maranchie
Study ID
NCT05127824
Phase
PHASE2
Status
Recruiting
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Conditions

  • Carcinoma, Renal Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Autologous alpha-DC1/TBVA vaccine — BIOLOGICAL
    Dendritic cells (DC) are derived from autologous (the subject's own) mononuclear cells in the peripheral blood obtained from the PRBC. In this case, "biologic product" and "biologic substance" are the same. The vaccine will be manufactured in the HCC-IMPCL, under cGMP conditions.
  • Cabozantinib — DRUG
    Cabozantinib tablets are supplied as film coated tablets containing cabozantinib malate equivalent to 20 mg and 60 mg of cabozantinib and contain microcrystalline cellulose, lactose anhydrous, hydoxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate and Opadry® yellow. The 60 mg tablets are oval and the 20 mg tablets are round. Doses of 40 mg will comprise two 20-mg tablets.

Study Details

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.

Key Dates

Start date
Jul 6, 2023
Status verified
Apr 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
42 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HLA-A2 postive
    The study will include 21 participants over the 18 years of age with newly diagnosed, clinically localized clear cell renal cell carcinoma, planned for surgical resection with curative intent. Participants receiving vaccine much be HLA-A2 positive.
  • Active Comparator: HLA-A2 negative
    Up to 21 additional participants who screen as HLA-A2 negative will be enrolled as non-treatment controls. These participants will not be required to undergo blood collection or study procedures

Primary Outcome Measure

Probability of immune response [ Time Frame: Up to 48 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Department of UrologyPittsburghPennsylvania15232
Morgan Pokora, RN
[email protected]
412-623-4886
Jodi Maranchie, MD
[email protected]
412-605-3019

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By research site
UPMC Department of Urology· Pittsburgh, PA

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