Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06631079
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
Personalised Neoantigen-targeting Cancer Vaccine NECVAX-NEO1 in Anti-PD-1PD-L1 Therapy in Patients With Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Phase III Multicenter Clinical Trial of NECVAX-NEO1 in Addition to Anti-PD-1 or Anti-PD-L1 Monoclonal Antibody Therapy in Patients With Solid Tumors
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 patients to evaluate the safety and effect of NECVAX-NEO1 administered in combination with PD-1PD-L1 mABs in patients with solid tumors Patients with solid tumors who will be treated with approved standard of care SoC PD-1 or PD-L1 monoclonal antibody inhibitor therapy and who after starting treatment with PD-1PD-L1 inhibitor reached either Stable Disease SD or Partial Response PR Cohort 1 or PD Cohort 2 according to RECIST 11 and iRECIST assessed at the Baseline visit may be enrolled in the study
Detailed Description:
Phase III multicenter open-label single-arm trial in patients to evaluate the safety and effect of NECVAX-NEO1 administered in combination with PD-1PD-L1 mABs in patients with solid tumors Patients with solid tumors who will be treated with approved standard of care SoC PD-1 or PD-L1 monoclonal antibody inhibitor therapy and who after starting treatment with PD-1PD-L1 inhibitor reached either Stable Disease SD or Partial Response PR Cohort 1 or PD Cohort 2 according to RECIST 11 and iRECIST assessed at the Baseline visit may be enrolled in the study
Personalised NECVAX-NEO1 is an oral bacteria-based therapeutic vaccine that incorporates a sequence of patient-specific neoantigens selected by the NEC Immune Profiler It is designed to stimulate the immune system of patients in order to induce a T-cell response that is able to specifically recognize and destroy tumor cells based on the patients own neoantigens NECVAX-NEO1 will be manufactured as a patient-specific Investigational Medicinal Product IMP for add-on therapy to the SoC PD-1PD-L1 inhibitor therapy
For each patient the trial will consist of
Screening visit To evaluate patients for inclusion in the trial The patient signs the informed consent form ICF eligibility is confirmed and a biopsy is taken to start manufacturing of the personalized NECVAX-NEO1
Induction period This is the SoC treatment period during which treatment with PD-1PD-L1 inhibitor therapy is started This is approximately 8 to 12 weeks depending on the type of PD-1PD-L1 inhibitor used The neoantigen selection and manufacturing of the personalized NECVAX-NEO1 takes place during the induction period
Baseline visit At this visit when the personalized NECVAX-NEO1 treatment is available and the RECISTiRECIST tumor assessment is performed by magnetic resonance imaging MRI or computed tomography CT scan eligibility will be re-confirmed after which the patient will be assigned to either Cohort 1 SD or PR according to RECIST 11 or Cohort 2 PD according to RECIST 11
Treatment period of up to 24 weeks which will mark the addition of new therapy to existing therapy ie prime and booster administrations of NECVAX-NEO1 in addition to PD-1PD-L1 inhibitor
Post-treatment Follow-up period of 4 weeks with an End of Treatment EoT visit at Week 28
After the EoT Week 28 a Long-Term Safety Monitoring Period following the administration of a genetically modified organism will occur for up to 24 months
Personalised NECVAX-NEO1 is an oral bacteria-based therapeutic vaccine that incorporates a sequence of patient-specific neoantigens selected by the NEC Immune Profiler It is designed to stimulate the immune system of patients in order to induce a T-cell response that is able to specifically recognize and destroy tumor cells based on the patients own neoantigens NECVAX-NEO1 will be manufactured as a patient-specific Investigational Medicinal Product IMP for add-on therapy to the SoC PD-1PD-L1 inhibitor therapy
For each patient the trial will consist of
Screening visit To evaluate patients for inclusion in the trial The patient signs the informed consent form ICF eligibility is confirmed and a biopsy is taken to start manufacturing of the personalized NECVAX-NEO1
Induction period This is the SoC treatment period during which treatment with PD-1PD-L1 inhibitor therapy is started This is approximately 8 to 12 weeks depending on the type of PD-1PD-L1 inhibitor used The neoantigen selection and manufacturing of the personalized NECVAX-NEO1 takes place during the induction period
Baseline visit At this visit when the personalized NECVAX-NEO1 treatment is available and the RECISTiRECIST tumor assessment is performed by magnetic resonance imaging MRI or computed tomography CT scan eligibility will be re-confirmed after which the patient will be assigned to either Cohort 1 SD or PR according to RECIST 11 or Cohort 2 PD according to RECIST 11
Treatment period of up to 24 weeks which will mark the addition of new therapy to existing therapy ie prime and booster administrations of NECVAX-NEO1 in addition to PD-1PD-L1 inhibitor
Post-treatment Follow-up period of 4 weeks with an End of Treatment EoT visit at Week 28
After the EoT Week 28 a Long-Term Safety Monitoring Period following the administration of a genetically modified organism will occur 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