Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04920617
Status:
RECRUITING
Last Update Posted:
2023-04-07
First Post:
2021-05-28
Brief Title:
DPX-Survivac and Pembrolizumab With and Without Intermittent Low-Dose Cyclophosphamide in Subjects With RelapsedRefractory Diffuse Large B-Cell Lymphoma
Sponsor:
ImmunoVaccine Technologies Inc IMV Inc
Organization:
ImmunoVaccine Technologies Inc IMV Inc
Study Overview
Official Title:
A Phase 2b Open-label Multicenter Randomized Parallel-Group Two-Stage Study of an Immunotherapeutic Treatment DPX-Survivac and Pembrolizumab With and Without Intermittent Low-Dose Cyclophosphamide in Subjects With RelapsedRefractory Diffuse Large B-Cell Lymphoma VITALIZE
Status:
RECRUITING
Status Verified Date:
2022-08
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:
VITALIZE
Brief Summary:
This is a Phase 2b randomized open label study to assess the safety and efficacy of DPX-Survivac and pembrolizumab with and without low-dose cyclophosphamide CPA in subjects with relapsed or refractory DLBCL
Detailed Description:
This is a Phase 2b randomized open label study to assess the safety and efficacy of DPX-Survivac and pembrolizumab with and without low-dose cyclophosphamide CPA in subjects with relapsed or refractory DLBCL
The study will enroll up to 102 subjects Eligible subjects will be randomized 11 to receive
Arm 1 DPX-Survivac pembrolizumab and intermittent low-dose CPA or
Arm 2 DPX-Survivac and pembrolizumab
All subjects will receive two 05 mL doses of DPX-Survivac 3 weeks apart on day 7 D7 and D28 followed by up to twelve 01 mL doses of DPX-Survivac 8 weeks apart Q8W
All subjects will receive pembrolizumab intravenously IV at a flat dose of 200 mg starting at D7 and on day 1 of each 3-week cycle thereafter ie D28 D49 D70 etc Q3W
For subjects randomized to Arm 1 intermittent oral CPA at a dose of 50 mg twice a day BID is administered from D0 to D6 7 days followed by 7 days off This 14-day cycle of 7 days on and 7 days off will be repeated until the end of study treatment
The study will enroll up to 102 subjects Eligible subjects will be randomized 11 to receive
Arm 1 DPX-Survivac pembrolizumab and intermittent low-dose CPA or
Arm 2 DPX-Survivac and pembrolizumab
All subjects will receive two 05 mL doses of DPX-Survivac 3 weeks apart on day 7 D7 and D28 followed by up to twelve 01 mL doses of DPX-Survivac 8 weeks apart Q8W
All subjects will receive pembrolizumab intravenously IV at a flat dose of 200 mg starting at D7 and on day 1 of each 3-week cycle thereafter ie D28 D49 D70 etc Q3W
For subjects randomized to Arm 1 intermittent oral CPA at a dose of 50 mg twice a day BID is administered from D0 to D6 7 days followed by 7 days off This 14-day cycle of 7 days on and 7 days off will be repeated until the end of study treatment
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KEYNOTE-C54 | OTHER | Merck Sharp Dohme Corp | None |