Ignite Creation Date:
2024-05-06 @ 1:54 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04154943
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-02-08
First Post:
2019-11-05
Brief Title:
Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma
Sponsor:
Regeneron Pharmaceuticals
Organization:
Regeneron Pharmaceuticals
Study Overview
Official Title:
A Phase 2 Study of Neoadjuvant Cemiplimab for Stage II to IV M0 Cutaneous Squamous Cell Carcinoma CSCC
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-01
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 primary objective of the study is to evaluate the efficacy of neoadjuvant cemiplimab as measured by Pathologic complete response pCR rate per independent central pathology review
The secondary objectives of the study are
To evaluate the efficacy of neoadjuvant cemiplimab on measures of disease response including
Major pathologic response mPR rate per independent central pathology review
pCR rate and mPR rate per local pathology review
ORR prior to surgery according to local assessment using RECIST 11
To evaluate the efficacy of neoadjuvant cemiplimab on event free survival EFS disease free survival DFS and overall survival OS
To evaluate the safety profile of neoadjuvant cemiplimab
To assess change in surgical plan ablative and reconstructive procedures from the screening period to definitive surgery both according to investigator review and independent surgical expert review
To assess change in post-surgical management plan radiation chemoradiation or observation from the screening period to post-surgery pathology review both according to investigator review and independent surgical expert review
The secondary objectives of the study are
To evaluate the efficacy of neoadjuvant cemiplimab on measures of disease response including
Major pathologic response mPR rate per independent central pathology review
pCR rate and mPR rate per local pathology review
ORR prior to surgery according to local assessment using RECIST 11
To evaluate the efficacy of neoadjuvant cemiplimab on event free survival EFS disease free survival DFS and overall survival OS
To evaluate the safety profile of neoadjuvant cemiplimab
To assess change in surgical plan ablative and reconstructive procedures from the screening period to definitive surgery both according to investigator review and independent surgical expert review
To assess change in post-surgical management plan radiation chemoradiation or observation from the screening period to post-surgery pathology review both according to investigator review and independent surgical expert review
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 |
|---|---|---|---|
| 2022-500811-37-00 | OTHER | EU CTR-CTIS | None |
| 2019-003007-35 | EUDRACT_NUMBER | None | None |