Ignite Creation Date:
2024-07-17 @ 10:56 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06496178
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-03
Brief Title:
A Phase 3 Study to Evaluate Petosemtamab Compared with Investigators Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients
Sponsor:
Merus NV
Organization:
Merus NV
Study Overview
Official Title:
A Phase 3 Open-label Randomized Controlled Study to Evaluate the Efficacy and Safety of Petosemtamab Compared with Investigators Choice Monotherapy Treatment in Previously Treated Patients with Incurable Metastaticrecurrent 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:
None
Brief Summary:
This is a phase 3 open-label randomized controlled multicenter study to compare petosemtamab vs investigators choice monotherapy in HNSCC patients for the second- and third-line treatment of incurable metastaticrecurrent disease
Detailed Description:
This is a phase 3 open-label randomized controlled multicenter study to compare petosemtamab vs investigators choice monotherapy in HNSCC patients for the second- and third-line treatment of incurable metastaticrecurrent disease HNSCC patients must have progressive disease PD on or after anti-PD-1 therapy and platinum-containing therapy Patients treated with platinum-containing therapy only in the adjuvant setting or in the context of multimodal therapy for locally advanced disease should have PD within 6 months of the last dose of platinum-containing therapy
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 |
|---|---|---|---|
| 2023-510322-32 | EUDRACT_NUMBER | None | None |