Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06319196
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-02-14
Brief Title:
Clear Me Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Clear Me Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High Risk Melanoma
Status:
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:
ClearMe
Brief Summary:
Clear-Me is a biomarker-driven phase II study that tests whether the combination anti- lymphocyte-activation gene-3 LAG3anti-programmed cell death protein 1PD-1 inhibition Bristol-Myers Squibb BMS986213 is superior to anti-PD-1 inhibition in patients with detectable circulating tumor deoxyribonucleic acid ctDNA following definitive surgery for high risk melanoma Patients will be allocated to either Arm A or Arm B via the process of randomization The randomization process will be stratified according to stage Stage 2A2B3A3B3C3D or 4 to ensure absolute balance between stage groups The investigators are choosing only 1 stratification factor disease stage as the investigators consider stage being the most significant prognosticating variable Each stage represents a biologically distinct entity with varying recurrence rate outcomes Block randomization will be performed to ensure equal sample sizes in the combination and monotherapy arms At least 54 patients will be included in the randomized part of the study The investigators are expecting approximately 20 of the patients to have detectable ctDNA after definite surgery Therefore approximately 270 patients are expected to be enrolled and tested for ctDNA in the entire study
Detailed Description:
None
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