Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06385080
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-04-23
Brief Title:
A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With RecurrentMetastatic Head and Neck Cancer
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
A Phase 1b2 Open-label Study of Amivantamab Monotherapy and Amivantamab in Addition to Standard of Care Therapeutic Agents in Participants With RecurrentMetastatic Head and Neck Squamous Cell Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-10
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:
OrigAMI-4
Brief Summary:
The purpose of this study is to determine safety and preliminary efficacy of amivantamab monotherapy amivantamab in addition to pembrolizumab and amivantamab in addition to paclitaxel in participants with recurrentmetastatic head and neck cancer The study will also confirm the recommended Phase 2 combination dose RP2CD for amivantamab in addition to paclitaxel
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 |
|---|---|---|---|
| 2023-508418-40-00 | REGISTRY | EUCT number | None |