Ignite Creation Date:
2024-05-06 @ 1:08 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03946358
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-05-26
First Post:
2019-05-07
Brief Title:
Combination of UCPVax Vaccine and Atezolizumab for the Treatment of Human Papillomavirus Positive Cancers VolATIL
Sponsor:
Centre Hospitalier Universitaire de Besancon
Organization:
Centre Hospitalier Universitaire de Besancon
Study Overview
Official Title:
A Phase II Study Evaluating the Interest to Combine UCPVax a CD4 TH1-inducer Cancer Vaccine and Atezolizumab for the Treatment of Human PapillomaVirus Positive Cancers
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-05
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:
VolATIL
Brief Summary:
70 all cases of cervical cancer 95 of anal cancers and about 70 of oropharyngeal cancers are linked to Human Papillomavirus HPV infection HPV oncogenic proteins are trans-activators of telomerase Indeed E6 oncoprotein transactivates the human telomerase hTert Our group has conducted a clinical trial NCT02402842 in advanced squamous cell anal cancer SCCA and investigators have shown a correlation between the presence of anti-HPV immunity and anti-telomerase T helpher 1 TH1 CD4 T cell responses establishing telomerase as an appropriate antigen in HPV-related cancers
Tumor-reactive CD4 T cells have been found to ensure efficient effector Cytotoxic T Lymphocytes CTL recruitment at the tumor site Promoting tumor specific TH1 CD4 activation might be an attractive therapeutic option to enhance anti-PD-1PD-L1 Programmed cell Death-1Programmed cell Death-Ligand1 efficacy However no option is currently available to expand tumor specific TH1 lymphocytes in most patients Then investigators have identified four novel MHC Major Histocompatibility Complex class II-restricted peptides derived from human telomerase reverse transcriptase TERT referred as Universal Cancer Peptides UCP UCPVax is a therapeutic cancer vaccine developed by our team and composed of two separate peptides called UCP2 and UCP4 derived from telomerase This UCPVax vaccine is currently evaluated in a multicenter phase III study in Non Small Lung Cancer NSCLC NCT2818426 and seems to show to be safe and immunogenic
PD-1PD-L1 immune checkpoint is a relevant candidate target for immunotherapy in HPV cancers based on the prominent role of PD-1 and its ligand PD-L1 in HPV-driven immune-evasion There is a strong rational of using PD-1 therapy in HPV cancers however anti-PD-1PD-L1 treatment induces a limited number of long term responses in HPV disease Combining anti-PD-1PD-L1 therapy with an antitumor vaccine gains serious consideration in HPV cancers Indeed anti-cancer vaccines can induce tumor-specific T cells expansion and activation and therefore restore the cancer-immunity cycle in patients lacking pre-existing anti-tumor responses
So investigators propose to determine the clinical interest and immunological efficacy of a treatment combining the CD4 helper T-inducer cancer vaccine UCPVax with atezolizumab in patients with HPV cancers by evaluation of the objective response rate at 4 months according to iRecist criteria
Tumor-reactive CD4 T cells have been found to ensure efficient effector Cytotoxic T Lymphocytes CTL recruitment at the tumor site Promoting tumor specific TH1 CD4 activation might be an attractive therapeutic option to enhance anti-PD-1PD-L1 Programmed cell Death-1Programmed cell Death-Ligand1 efficacy However no option is currently available to expand tumor specific TH1 lymphocytes in most patients Then investigators have identified four novel MHC Major Histocompatibility Complex class II-restricted peptides derived from human telomerase reverse transcriptase TERT referred as Universal Cancer Peptides UCP UCPVax is a therapeutic cancer vaccine developed by our team and composed of two separate peptides called UCP2 and UCP4 derived from telomerase This UCPVax vaccine is currently evaluated in a multicenter phase III study in Non Small Lung Cancer NSCLC NCT2818426 and seems to show to be safe and immunogenic
PD-1PD-L1 immune checkpoint is a relevant candidate target for immunotherapy in HPV cancers based on the prominent role of PD-1 and its ligand PD-L1 in HPV-driven immune-evasion There is a strong rational of using PD-1 therapy in HPV cancers however anti-PD-1PD-L1 treatment induces a limited number of long term responses in HPV disease Combining anti-PD-1PD-L1 therapy with an antitumor vaccine gains serious consideration in HPV cancers Indeed anti-cancer vaccines can induce tumor-specific T cells expansion and activation and therefore restore the cancer-immunity cycle in patients lacking pre-existing anti-tumor responses
So investigators propose to determine the clinical interest and immunological efficacy of a treatment combining the CD4 helper T-inducer cancer vaccine UCPVax with atezolizumab in patients with HPV cancers by evaluation of the objective response rate at 4 months according to iRecist criteria
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None