Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05773859
Status:
RECRUITING
Last Update Posted:
2023-07-12
First Post:
2023-02-12
Brief Title:
NEOadjuvant Dendritic Cell Vaccination for Ovarian Cancer
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Induction of Neo-Antigen Specific Cytotoxic T Cells by Autologous Tumor Lysate-loaded Specialized Cross-Presenting Dendritic Cells in Epithelial Ovarian Cancer Patients Treated With Neoadjuvant Chemotherapy the NEODOC Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEODOC
Brief Summary:
This goal of this single arm single center exploratory phase III clinical trial is to learn more about the immunological efficacy safety and feasibility of an autologous tumor lysate-loaded autologous XP-DC cDC1-based vaccine in patients with ovarian cancer
Detailed Description:
Epithelial ovarian cancer EOC is the deadliest gynecological malignancy worldwide Despite intensified treatment 5-year overall survival rates only improved modestly over the last 20 years and remain low at around 30 for patients with advanced disease in the Netherlands To this day results from trials with the checkpoint inhibitors that have revolutionized treatment in other cancer types have been disappointing in EOC Therefore novel effective therapies are long awaited
Recently naturally circulating blood -derived dendritic cells nDC were shown to be potent in inducing cytotoxic immune responses and tumor regression in cancer patients An even more specialized DC subset referred to as cDC1 conventional Dendritic Cells type 1 or XP-DC specialized cross presenting DC have shown their superiority in preclinical models They are better at inducing cytotoxic T-cell responses against tumors after uptake of necrotic tumor cell material a phenomenon called cross-presentation This capability in cross-presentation makes XP-DC an ideal DC type in combination with tumor lysate-loading to induce immune responses against the scarce neoantigens present in EOC tumors
The objective of this exploratory trial is to investigate the immunological efficacy as well as safety and feasibility of tumor-lysate loaded XP-DC in EOC patients undergoing neo-adjuvant chemotherapy To this end 10 patients with stage III ovarian cancer will be included and offered a combined approach with DC vaccination in addition to standard-of-care chemotherapy and surgery Extensive monitoring of the immune system throughout the course of the trial will be performed
Recently naturally circulating blood -derived dendritic cells nDC were shown to be potent in inducing cytotoxic immune responses and tumor regression in cancer patients An even more specialized DC subset referred to as cDC1 conventional Dendritic Cells type 1 or XP-DC specialized cross presenting DC have shown their superiority in preclinical models They are better at inducing cytotoxic T-cell responses against tumors after uptake of necrotic tumor cell material a phenomenon called cross-presentation This capability in cross-presentation makes XP-DC an ideal DC type in combination with tumor lysate-loading to induce immune responses against the scarce neoantigens present in EOC tumors
The objective of this exploratory trial is to investigate the immunological efficacy as well as safety and feasibility of tumor-lysate loaded XP-DC in EOC patients undergoing neo-adjuvant chemotherapy To this end 10 patients with stage III ovarian cancer will be included and offered a combined approach with DC vaccination in addition to standard-of-care chemotherapy and surgery Extensive monitoring of the immune system throughout the course of the trial will be performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None