Ignite Creation Date:
2024-10-25 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06631092
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
Personalised Neoantigen-targeting Cancer Vaccine NECVAX-NEO1 in Neoadjuvant Triple-negative Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Phase III Multicenter Clinical Trial of NECVAX-NEO1 as add-on to First-line Neoadjuvant Anti-PD-1 Monoclonal Antibody Therapy in Patients With Triple-negative Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase III multicenter open-label single-arm trial in triple-negative breast cancer patients under first-line neoadjuvant therapy with approved standard of care anti-PD-1 monoclonal antibody PD-1 inhibitor epirubicincyclophosphamide chemotherapy and nab-paclitaxel therapy NECVAX-NEO1 treatment in addition to standard of care anti-PD1 monoclonal antibody therapy can be prolonged after breast cancer surgery for another 24 weeks according to the investigators decision taking into consideration the study patients health status
Detailed Description:
Phase III multicenter open-label single-arm trial in triple-negative breast cancer patients under first-line neoadjuvant therapy with approved standard of care anti-PD-1 monoclonal antibody PD-1 inhibitor epirubicincyclophosphamide chemotherapy and nab-paclitaxel therapy Optionally NECVAX-NEO1 treatment in addition to standard of care anti-PD1 monoclonal antibody therapy can be prolonged after breast cancer surgery for another 24 weeks according to the investigators decision taking into consideration the study patients health status
Personalized NECVAX-NEO1 constructs containing an eukaryotic expression plasmid encoding a series of selected neoantigen epitopes will be manufactured for administration as a patient-specific investigational medicinal product IMP The IMP will be administered and as an add-on therapy to the standard of care PD-1 inhibitor therapy
The trial will consist of mainly
A Screening and Induction period of up to 12 weeks including the neoantigen selection and manufacturing phase and first-line treatment with PD-1 inhibitor therapy with epirubicin 90 mgm2cyclophosphamide 600 mgm2 every 3 weeks combined with pembrolizumab 200 mg as standard of care treatment
A Treatment period of up to 12 weeks with prime and booster administrations of NECVAX-NEO1 in addition to continuation of PD-1 inhibitor pembrolizumab 200 mg every 3 weeks and nab-paclitaxel 125 mgm2 once a week for 12 weeks up to planned tumor surgery
An optional prolongation of booster administration of NECVAX-NEO1 in addition to continuation of PD-1 inhibitor up to 24 weeks and
A Follow-up period of 4 weeks with an End of Treatment EoT visit at Week 16 or at Week 40 in case of the optional treatment prolongation
A long-term safety follow-up period observation period after EoT for up to 24 months
Personalized NECVAX-NEO1 constructs containing an eukaryotic expression plasmid encoding a series of selected neoantigen epitopes will be manufactured for administration as a patient-specific investigational medicinal product IMP The IMP will be administered and as an add-on therapy to the standard of care PD-1 inhibitor therapy
The trial will consist of mainly
A Screening and Induction period of up to 12 weeks including the neoantigen selection and manufacturing phase and first-line treatment with PD-1 inhibitor therapy with epirubicin 90 mgm2cyclophosphamide 600 mgm2 every 3 weeks combined with pembrolizumab 200 mg as standard of care treatment
A Treatment period of up to 12 weeks with prime and booster administrations of NECVAX-NEO1 in addition to continuation of PD-1 inhibitor pembrolizumab 200 mg every 3 weeks and nab-paclitaxel 125 mgm2 once a week for 12 weeks up to planned tumor surgery
An optional prolongation of booster administration of NECVAX-NEO1 in addition to continuation of PD-1 inhibitor up to 24 weeks and
A Follow-up period of 4 weeks with an End of Treatment EoT visit at Week 16 or at Week 40 in case of the optional treatment prolongation
A long-term safety follow-up period observation period after EoT for up to 24 months
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