Ignite Creation Date:
2024-05-06 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05243524
Status:
TERMINATED
Last Update Posted:
2023-09-13
First Post:
2022-02-07
Brief Title:
Maveropepimut-S MVP-S and Low-Dose CPA in Patients With Platinum-Resistant Ovarian Cancer
Sponsor:
ImmunoVaccine Technologies Inc IMV Inc
Organization:
ImmunoVaccine Technologies Inc IMV Inc
Study Overview
Official Title:
Phase 2b Single Arm Study of Maveropepimut-S and Low-Dose Cyclophosphamide in Subjects With Platinum-Resistant Epithelial Ovarian Cancer
Status:
TERMINATED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closure of IMV operations
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AVALON
Brief Summary:
Phase 2 single arm study to assess the efficacy and safety of maveropepimut-S MVP-S and low-dose cyclophosphamide CPA in subjects with recurrent platinum resistant ovarian cancer
Detailed Description:
A Simon two-stage statistical design to assess MVP-S in combination with low dose CPA in platinum-resistant epithelial ovarian cancer patients who have received no greater than 4 previous lines of anti-cancer therapy
MVP-S previously called DPX-Survivac was recently evaluated in a small Phase 2 single arm study of ovarian cancer patients known as DeCidE1 NCT02785250
MVP-S previously called DPX-Survivac was recently evaluated in a small Phase 2 single arm study of ovarian cancer patients known as DeCidE1 NCT02785250
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None