Ignite Creation Date:
2024-10-25 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06624475
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
Neoadjuvant Opdualag Versus Nivolumab for Resectable High-Risk Basal Cell Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Phase II Trial Neoadjuvant Opdualag Versus Nivolumab for Resectable High-Risk Basal 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:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 2 clinical trial with a 21 randomization comparing neoadjuvant Nivolumab Relatlimab Opdualag vs neoadjuvant Nivolumab in patients with resectable high risk BCC HR BCC
Detailed Description:
Patients will be treated with 4 cycles of neoadjuvant Opdualag cohort 1 or Nivolumab cohort 2 given every 4 weeks followed by surgical resection There will be an option to proceed directly to surgery after 2 cycles of therapy should patients have frank progression of disease based on clinical evaluation There will also be an option to continue with Opdualag or Nivolumab beyond 4 cycles if there is ongoing clinical benefit per investigator discretion If there is clinical evidence of a clinical complete response patients may forgo surgery per investigator discretion The primary outcome of pathologic response rate will be assessed at the time of resection Patients will then be monitored for disease recurrence and other secondary outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None