Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06151236
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2023-11-21
Brief Title:
Neoadjuvant Nivolumab and Relatlimab in Merkel 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 I To III Resectable Merkel Cell Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-03
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 clinical trial is to test neoadjuvant dual immunotherapy in Merkel cell carcinoma with the aim to improve 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 I 10 mm to stage III Merkel cell carcinoma compared to neoadjuvant nivolumab 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 |
|---|---|---|---|
| CA224-1064 | OTHER | BMS | None |