Ignite Creation Date:
2024-05-06 @ 4:29 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05005442
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-01
First Post:
2021-08-12
Brief Title:
A Study of PembrolizumabVibostolimab MK-7684A in RelapsedRefractory Hematological Malignancies MK-7684A-004 KEYVIBE-004
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase 2 Open-label Study to Evaluate the Safety and Efficacy of MK-7684A MK-7684 Vibostolimab With MK-3475 Pembrolizumab Coformulation in Participants With Relapsed or Refractory Hematological Malignancies
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
The purpose of the study is to determine the safety and tolerability of pembrolizumabvibostolimab MK-7684A in hematological malignancies This study will also evaluate the overall response rate ORR the duration of response DOR and disease control rate DCR following administration of pembrolizumabvibostolimab In addition this study will characterize pharmacokinetic PK profile of vibostolimab MK-7684
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-7684A-004 | OTHER | None | None |
| KEYVIBE-004 | OTHER | None | None |
| 2021-001700-15 | EUDRACT_NUMBER | Merck | None |