Ignite Creation Date:
2024-05-06 @ 4:12 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04901741
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2021-05-20
Brief Title:
Olaptesed With Pembrolizumab and Nanoliposomal Irinotecan or GemcitabineNab-Paclitaxel in MSS Pancreatic Cancer
Sponsor:
TME Pharma AG
Organization:
TME Pharma AG
Study Overview
Official Title:
An Open-label Phase 2 Study of Olaptesed Pegol NOX-A12 Combined With Pembrolizumab and Nanoliposomal Irinotecan5-FULeucovorin or GemcitabineNab-paclitaxel in Microsatellite-stable Metastatic Pancreatic Cancer Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
OPTIMUS
Brief Summary:
The purpose of this study is to provide a gono-go decision for a randomized expansion study by assessing the disease control rate DCR at 6 weeks for the combination of olaptesed pegol on top of pembrolizumab and Arm 1 nanoliposomal irinotecan 5-FU and leucovorin or Arm 2 gemcitabine and nab-paclitaxel to assess safety and tolerability and time-to-event endpoints
Detailed Description:
None
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 |
|---|---|---|---|
| MK-3475-B01 | OTHER | Merck Sharp Dohme LLC | None |
| 2021-001963-25 | EUDRACT_NUMBER | None | None |
| KEYNOTE-B01 | OTHER | None | None |