Loading clinical trials...

Autologous Dendritic Cell Vaccine in Kidney Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Autologous Dendritic Cell Vaccine in Kidney Cancer

A Phase 2a Study to Type I-Polarized Autologous Dendritic Cell Vaccines Incorporating Tumor Blood Vessel Antigen (TBVA)-Derived Peptides in Combination With Cabozantinib in Patients With Localized Clear Cell Renal Cancer.

NCT05127824•Jodi Maranchie

View on ClinicalTrials.gov

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.

Detailed Description

Participants with newly diagnosed, non-metastatic, histologically confirmed, clear cell renal cell carcinoma (ccRCC) who have elected to undergo surgical resection, will receive neoadjuvant autologous Tumor Blood Vessel Antigen (TBVA)-Dendritic Cell Vaccine intradermally every 2 weeks x 2 (days 7(+/-3) and 21(+/-3)) prior to surgery on day 31(+7) with oral cabozantinib 20 mg daily for 10 days. We hypothesize that treated renal tumors will demonstrate maturation and organization of the tumor endothelium with normalization of endothelial markers and formation of tertiary lymphoid structure capable of promoting specific T-cell induction.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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.
•2. 18 years or older (male or female) with an ECOG performance status of 0 or 1.
•3. Have serotype HLA-A2+ if receiving vaccine.
•4. Capable of understanding and complying with the protocol requirements and have signed the informed consent document.
•5. Adequate organ and marrow function, based upon meeting all of the following laboratory criteria within 14 days before first dose of study treatment:
•1. Absolute neutrophil count (ANC) ≥ 1500/µL without granulocyte colony- stimulating factor support.
•2. White blood cell count ≥ 2500/µL.
•3. Platelets ≥ 100,000/µL without transfusion.
•4. Hemoglobin ≥ 9 g/dL (≥ 90 g/L).
•5. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 3x upper limit of normal (ULN). ALP ≤ 5x ULN with documented bone metastases.
+7 more criteria

Exclusion Criteria

•1. 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.
•2. Known or suspected metastatic disease.
•3. Active Hepatitis B or Hepatitis C infection or any other active infection requiring intravenous therapy.
•4. Blood transfusion within two weeks prior to leukapheresis.
•5. Prior treatment with cabozantinib.
•6. Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within two weeks before first dose of study treatment.
•7. Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within four weeks before first dose of study treatment.
•9. Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants are the following:
•1. Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).
•2. Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.
+24 more criteria

Locations (1)

UPMC Department of Urology

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

July 6, 2023

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

May 4, 2025

Enrollment

ESTIMATED participants

Conditions

Carcinoma, Renal Cell

Interventions

Autologous alpha-DC1/TBVA vaccine

BIOLOGICAL

Cabozantinib

DRUG

Contacts

Morgan Pokora, RN

CONTACT

412-623-4886 pokoraml3@upmc.edu

Jodi Maranchie, MD

CONTACT

412-605-3019 maranchijk@upmc.edu

A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Anticancer Therapies in Adults With Locally Advanced or Metastatic Renal Cell Cancer

NCT07227415

Carcinoma, Renal CellAdvanced Renal Cell Carcinoma+11 more

View study

RECRUITINGPHASE2

A Study of Oncobax®-AK in Patients With Advanced Solid Tumors

NCT05865730

Carcinoma, Renal CellCarcinoma, Non-Small-Cell Lung

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Autologous Dendritic Cell Vaccine in Kidney Cancer

Inclusion Criteria

Exclusion Criteria

A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Anticancer Therapies in Adults With Locally Advanced or Metastatic Renal Cell Cancer

A Study of Oncobax®-AK in Patients With Advanced Solid Tumors

A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022)

A Study of Combination Spartalizumab and Canakinumab in Patients With Localized Clear Cell Renal Cell Carcinoma

A Study of Atezolizumab in Combination With Cabozantinib Compared to Cabozantinib Alone in Participants With Advanced Renal Cell Carcinoma After Immune Checkpoint Inhibitor Treatment

A Phase II Trial of the DNA Methyl Transferase Inhibitor, Guadecitabine (SGI-110), in Children and Adults With Wild Type GIST,Pheochromocytoma and Paraganglioma Associated With Succinate Dehydrogenase Deficiency and HLRCC-associated Kidney Cancer