Ignite Creation Date:
2024-05-06 @ 4:27 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04990479
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-03-13
First Post:
2021-07-15
Brief Title:
Nous-PEV a Novel Immunotherapy for Lung Cancer and Melanoma
Sponsor:
Nouscom SRL
Organization:
Nouscom SRL
Study Overview
Official Title:
An Open-Label Multicenter Non-Randomized Dose-Confirmation and Cohort-Expansion Phase 1b Study to Evaluate the Safety Tolerability and Anti-Tumor Activity of Nous-PEV With Pembrolizumab in Patients With Unresectable Stage III IV Cutaneous Melanoma and With Stage IV NSCLC PDL1 50
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-03
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:
None
Brief Summary:
From Protocol v30 dated 16Jun2022 This is an international multicenter open-label multiple cohort First in Human phase 1b clinical study designed to evaluate safety tolerability and immunogenicity and to detect any preliminary evidence of anti-tumor activity of a personalized vaccine PEV based on GAd-PEV priming and MVA-PEV boosting combined with SoC first-line immunotherapy using an anti-PD-1 checkpoint inhibitor in patients with unresectable stage IIIIV cutaneous melanoma or with stage IV NSCLC PDL1 50 The PEV vaccines will be prepared on an individual basis following a tumor biopsy performed at the time of screening and subsequent NGS analysis to identify patient-specific tumor mutations Both neoantigen-encoding genetic vaccines are administered intramuscularly using 1 prime with GAd-PEV and 3 boosts with MVA-PEV in combination with the licensed programmed death receptor-1 PD-1-blocking antibody pembrolizumab in adult patients in patients with unresectable stage IIIIV cutaneous melanoma Cohort a or with stage IV NSCLC PDL1 50 Cohort b
Detailed Description:
Overall Study Design
This is an open-label non-randomized dose-confirmation and cohort expansion phase 1b first-in-human study in which 28 patients expandable up to 34 evaluable patients in case of DLT
Study IMPs
Nous-PEV vaccine is composed of 2 sets of IMPs
GAd-PEV
MVA-PEV
Treatment phases
A Induction phase with pembrolizumab cycles 1 2 and 3 B Priming phase including 1 GAd-PEV administration with pembrolizumab cycle 4
C Boosting phase including 3 boosting administrations of MVA-PEV with pembrolizumab cycles 5 6 and 7
This is an open-label non-randomized dose-confirmation and cohort expansion phase 1b first-in-human study in which 28 patients expandable up to 34 evaluable patients in case of DLT
Study IMPs
Nous-PEV vaccine is composed of 2 sets of IMPs
GAd-PEV
MVA-PEV
Treatment phases
A Induction phase with pembrolizumab cycles 1 2 and 3 B Priming phase including 1 GAd-PEV administration with pembrolizumab cycle 4
C Boosting phase including 3 boosting administrations of MVA-PEV with pembrolizumab cycles 5 6 and 7
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-004759-35 | EUDRACT_NUMBER | None | None |