Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06448026
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-03
Brief Title:
Cemiplimab and Cetuximab Prior Salvage Surgery in Patients With Recurrent Oral Cavity Squamous Cell Carcinoma OCSCC
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Cemiplimab and Cetuximab Prior Salvage Surgery in Patients With Recurrent Oral Cavity Squamous Cell Carcinoma OCSCC
Status:
NOT_YET_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:
To learn if giving cemiplimab and cetuximab before salvage surgery can help to control recurrent oral cavity squamous cell carcinoma
Detailed Description:
Primary Objective
- To assess the efficacy of cemiplimab and cetuximab in patients with recurrent oral cavity squamous cell carcinoma
Secondary Objective
To assess safety of cemiplimab and cetuximab prior salvage surgery
To evaluate the efficacy of cemiplimab and cetuximab prior salvage surgery on measures
To estimate the one-year disease free survival DFS
To estimate the median overall survival OS
TertiaryExploratory Objective
To explore patient-reported outcomes PRO during CC and following salvage surgical resection
Assess impact of cemiplimab and cetuximab on surgery and adjuvant therapy
To explore biomarkers that may predict response to therapy
- To assess the efficacy of cemiplimab and cetuximab in patients with recurrent oral cavity squamous cell carcinoma
Secondary Objective
To assess safety of cemiplimab and cetuximab prior salvage surgery
To evaluate the efficacy of cemiplimab and cetuximab prior salvage surgery on measures
To estimate the one-year disease free survival DFS
To estimate the median overall survival OS
TertiaryExploratory Objective
To explore patient-reported outcomes PRO during CC and following salvage surgical resection
Assess impact of cemiplimab and cetuximab on surgery and adjuvant therapy
To explore biomarkers that may predict response to 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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-04824 | OTHER | NCI-CTRP Clinical Registry | None |