Who is sponsoring NCT02692976?

NCT02692976 is sponsored by Radboud University Medical Center.

What condition does NCT02692976 study?

NCT02692976 studies Prostatic Neoplasms, Immunotherapy, Dendritic Cells, Vaccines.

What drugs are being tested in NCT02692976?

Interventions: mDC vaccination, pDC vaccination, mDC and pDC vaccination.

What is the status of NCT02692976?

NCT02692976 is currently COMPLETED.

Last reviewed 2019-11-13 · How we verify

A Randomized Phase IIa Study: Natural Dendritic Cells for Immunotherapy of Chemo-naive Metastatic Castration-resistant Prostate Cancer Patients

NCT02692976 Phase 2 COMPLETED

Prostate cancer is the only type of cancer in which conventional dendritic cells (DC) treatment has a beneficial effect on the overall survival. In this study investigators aim to show immunologic efficacy of tumor-peptide loaded natural DC in metastatic castration-resistant prostate cancer patients (mCRPC). The immunomonitoring will include: 1. functional response and tetramer analysis of delayed-type hypersensitivity infiltrating lymphocytes against tumor peptides and 2. type I interferon (IFN) gene expression in peripheral blood mononuclear cells, and 3. proliferative, effector cytokine- and humoral responses to keyhole limpet hemocyanin, a immunogenic protein providing T cell help. The secondary objectives are the safety and feasibility of natural DC vaccinations, the influence on the quality of life during treatment with natural DC, and the clinical efficacy of treatment.

Details

Lead sponsor	Radboud University Medical Center
Phase	Phase 2
Status	COMPLETED
Enrolment	21
Start date	2015-09
Completion	2019-03-06

Conditions

Prostatic Neoplasms
Immunotherapy
Dendritic Cells
Vaccines

Interventions

mDC vaccination
pDC vaccination
mDC and pDC vaccination

Primary outcomes

The immunogenicity of tumor-peptide loaded natural blood dendritic cells (myeloid DC, plasmacytoid DC and the combination of mDC/pDC) in metastatic castration-resistant prostate cancer (mCRPC) patients — 18 months
a.functional response and tetramer analysis of delayed-type hypersensitivity infiltrating lymphocytes against tumor peptides.
The immunogenicity of tumor-peptide loaded natural blood dendritic cells (myeloid DC, plasmacytoid DC and the combination of mDC/pDC) in metastatic castration-resistant prostate cancer (mCRPC) patients — 18 months
b.type I interferon (IFN) gene expression in peripheral blood mononuclear cells.
The immunogenicity of tumor-peptide loaded natural blood dendritic cells (myeloid DC, plasmacytoid DC and the combination of mDC/pDC) in metastatic castration-resistant prostate cancer (mCRPC) patients — 18 months
c.proliferative, effector cytokine- and humoral responses to keyhole limpet hemocyanin, a immunogenic protein providing T cell help.

Countries

Netherlands