Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06418724
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-04-12
Brief Title:
Neoadjuvant PD-1 Inhibitor and EGFR Inhibitor in Locally Advanced Cutaneous Squamous Cell Carcinoma
Sponsor:
Melanoma and Skin Cancer Trials Limited
Organization:
Melanoma and Skin Cancer Trials Limited
Study Overview
Official Title:
Neoadjuvant PD-1 Inhibitor and EGFR Inhibitor in Locally Advanced Cutaneous Squamous Cell Carcinoma
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:
NEOPECS
Brief Summary:
The NEOPECS trial is a phase II prospective single-arm non-randomised interventional trial for patients with borderline resectable locally advanced cutaneous squamous cell carcinoma with a 6-participant safety lead in to ensure safety of the combination in the neoadjuvant setting across 3 sites in Australia
Detailed Description:
As cutaneous squamous cell carcinoma typically occurs on sun-exposed areas of the head and neck surgical resection of advanced disease can have significant morbidity and disfigurement and strategies to downstage disease prior to surgery improve chance of R0 resection and reduce the risk of post-surgical relapse remain an area of need
This study aims to determine the preliminary activity and tolerability of neo-adjuvant combination cemiplimab and cetuximab in unresectable locally advanced cutaneous squamous cell carcinoma by clinical downstaging rate to resectable status
This study aims to determine the preliminary activity and tolerability of neo-adjuvant combination cemiplimab and cetuximab in unresectable locally advanced cutaneous squamous cell carcinoma by clinical downstaging rate to resectable status
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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