Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06288191
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-02-04
Brief Title:
Neoadjuvant Nivolumab and Relatlimab in Cutaneous Squamous Cell Carcinoma
Sponsor:
Melanoma Institute Australia
Organization:
Melanoma Institute Australia
Study Overview
Official Title:
A Phase 2 Open Label Single Arm Clinical Trial of Neoadjuvant Nivolumab and Relatlimab in Stage II To IV Resectable Cutaneous Squamous Cell Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 goal of this study is to test neoadjuvant therapy with the dual inhibition of Programmed cell death protein 1 PD-1 and lymphocyte activation gene 3 LAG-3 immune checkpoint pathways in a cohort of treatment-naïve resectable stage II to IV cutaneous squamous cell carcinoma on the pathological response rate pCR and recurrence-free survival
Detailed Description:
This is a phase 2 open label single cohort single centre clinical trial of neoadjuvant immunotherapy with dual inhibition of PD-1 and LAG-3 immune checkpoint pathways The hypothesis is that neoadjuvant therapy produces a higher pathological response rate pCR and a longer recurrence-free survival in a cohort of treatment-naïve patients with resectable stage II to IV M0 cutaneous squamous cell carcinoma compared to neoadjuvant cemiplimab monotherapy in Checkmate 358 n123 NCT02488759 historical control
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CA224-1065 | OTHER | Bristol-Myers Squibb | None |