Ignite Creation Date:
2024-05-06 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 2:16 PM
Study NCT ID:
NCT05092360
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2021-10-13
Brief Title:
Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer ARTISTRY-7
Sponsor:
Mural Oncology Inc
Organization:
Mural Oncology Inc
Study Overview
Official Title:
A Phase 3 Multicenter Open-Label Randomized Study of Nemvaleukin Alfa in Combination With Pembrolizumab Versus Investigators Choice Chemotherapy in Patients With Platinum-Resistant Epithelial Ovarian Fallopian Tube or Primary Peritoneal Cancer ARTISTRY-7
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
ARTISTRY-7
Brief Summary:
This is a Phase 3 multicenter open-label randomized study of nemvaleukin in combination with pembrolizumab versus protocol-specific Investigators choice chemotherapy in patients with platinum-resistant epithelial ovarian fallopian tube or primary peritoneal cancer
Detailed Description:
Patients will be centrally allocated in a randomized fashion 3113 to receive either
Arm 1 Nemvaleukin and pembrolizumab combination therapy Arm 2 Pembrolizumab monotherapy enrollment completed Arm 3 Nemvaleukin monotherapy enrollment completed Arm 4 Investigators choice chemotherapy include one of the following pegylated liposomal doxorubicin PLD paclitaxel topotecan or gemcitabine
Arm 1 Nemvaleukin and pembrolizumab combination therapy Arm 2 Pembrolizumab monotherapy enrollment completed Arm 3 Nemvaleukin monotherapy enrollment completed Arm 4 Investigators choice chemotherapy include one of the following pegylated liposomal doxorubicin PLD paclitaxel topotecan or gemcitabine
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-C71 | OTHER | Merck | None |
| GOG-3063 | OTHER | None | None |
| ENGOT-OV68 | OTHER | None | None |
| APGOT-OV8 | OTHER | None | None |