Ignite Creation Date:
2024-05-06 @ 3:44 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02364492
Status:
COMPLETED
Last Update Posted:
2022-04-01
First Post:
2015-02-10
Brief Title:
A Phase I Study of a Therapeutic Vaccine Candidate in Patients With Localized Breast Cancer at High-Risk of Relapse
Sponsor:
Institut Pasteur
Organization:
Institut Pasteur
Study Overview
Official Title:
An Open Label First-in-Human Adjuvant Phase I Study of a Synthetic Multiple Antigenic Glycopeptide Displaying a Tri Tn Glycotop MAG-Tn3 Plus AS15 as a Therapeutic Vaccine Candidate in Patients With Non Metastatic HER2 Negative Localized Breast Cancer at High-Risk of Relapse
Status:
COMPLETED
Status Verified Date:
2021-07
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:
MAGTRIVACSEIN
Brief Summary:
The purpose of this study is to evaluate if a maximum tolerated dose MTD can be obtained following 2 administrations of the MAG-Tn3 AS15 cancer vaccine when administered at doses of 30 µg 100 µg or 300 µg IM every three weeks
Detailed Description:
This study is a three dose level open-label non-randomized dose-escalation study Phase I of the safety of the vaccine candidate MAG-Tn3 AS15 administered to patients with HER2 negative high-risk localized breast cancer in remission
A maximum of 30 patients will be included in the study
3 or 6 patients in the 1st dose level 30 µg
6 or 12 patients in the 2nd dose level 100 µg
6 or 12 patients in the 3rd dose level 300 µg The clinical study phase I is composed of a vaccination period of about 4 months 16 weeks and a follow-up period of 36 months 3 years
Each patient will receive one of the three escalating doses of MAG-Tn3 in combination with a fixed dose of AS15 adjuvant
The subject will receive 6 vaccine injections administered by intramuscular injection with a 3-weeks interval between injections Each patient will be followed 36 months after the last injection The follow-up period is composed of a short-term follow-up period of 6 months and a long-term follow-up period of 30 months
A total of 20 visits will be required for each patient Clinical data and blood samples will be collected for analysis for each patient
Clinical study data will be recorded for each patient on source documentation and then entered on electronic CRFs eCRFs using a proprietary Electronic Data Capture EDC Clinical Data Base Software System The eCRF data are to be entered by site personnel trained in EDC data entry
A monitor will visit the site regularly to check the completeness of patient records the accuracy of entries on the e-CRFs the adherence to the protocol and to Good Clinical Practice the progress of enrollment and to ensure that study drug is being stored dispensed and accounted for according to specifications
Institut Pasteur or designated CRO will conduct data management Data entered into EDC will be housed in a central database Changes will be tracked to provide an audit trail Interactive data checks will be carried out as applicable during the data entry process Additional data checks are programmed to identify errors in the SAS datasets Applicable queries based on the SAS datasets will be added to EDC for resolution by data management personnel At the conclusion of the study when all data have been entered and source document verified with no outstanding queries remaining the Investigator of each site will be required to electronically sign each patients casebook to confirm that the data for each patient are complete and accurate and consistent with the patients source documents The data will then be locked to prevent further editing
Concomitant medications entered into the database will be coded using the WHO Drug Reference List which employs the Anatomical Therapeutic Chemical classification system Medical historycurrent medical conditions and adverse events terminology will be coded using the Medical dictionary for regulatory activitiesThe newest version of the dictionary at data base lock will be used
A maximum of 30 patients will be included in the study
3 or 6 patients in the 1st dose level 30 µg
6 or 12 patients in the 2nd dose level 100 µg
6 or 12 patients in the 3rd dose level 300 µg The clinical study phase I is composed of a vaccination period of about 4 months 16 weeks and a follow-up period of 36 months 3 years
Each patient will receive one of the three escalating doses of MAG-Tn3 in combination with a fixed dose of AS15 adjuvant
The subject will receive 6 vaccine injections administered by intramuscular injection with a 3-weeks interval between injections Each patient will be followed 36 months after the last injection The follow-up period is composed of a short-term follow-up period of 6 months and a long-term follow-up period of 30 months
A total of 20 visits will be required for each patient Clinical data and blood samples will be collected for analysis for each patient
Clinical study data will be recorded for each patient on source documentation and then entered on electronic CRFs eCRFs using a proprietary Electronic Data Capture EDC Clinical Data Base Software System The eCRF data are to be entered by site personnel trained in EDC data entry
A monitor will visit the site regularly to check the completeness of patient records the accuracy of entries on the e-CRFs the adherence to the protocol and to Good Clinical Practice the progress of enrollment and to ensure that study drug is being stored dispensed and accounted for according to specifications
Institut Pasteur or designated CRO will conduct data management Data entered into EDC will be housed in a central database Changes will be tracked to provide an audit trail Interactive data checks will be carried out as applicable during the data entry process Additional data checks are programmed to identify errors in the SAS datasets Applicable queries based on the SAS datasets will be added to EDC for resolution by data management personnel At the conclusion of the study when all data have been entered and source document verified with no outstanding queries remaining the Investigator of each site will be required to electronically sign each patients casebook to confirm that the data for each patient are complete and accurate and consistent with the patients source documents The data will then be locked to prevent further editing
Concomitant medications entered into the database will be coded using the WHO Drug Reference List which employs the Anatomical Therapeutic Chemical classification system Medical historycurrent medical conditions and adverse events terminology will be coded using the Medical dictionary for regulatory activitiesThe newest version of the dictionary at data base lock will be used
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None