Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06561087
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-16
Brief Title:
Phase II Randomized Placebo- Controlled Study of Intralesional Nivolumab for High-risk Oral Premalignant Lesions
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase II Randomized Placebo- Controlled Study of Intralesional Nivolumab for High-risk Oral Premalignant Lesions
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:
To evaluate the antitumor efficacy of intralesional injections of nivolumab in patients with high-risk oral premalignant lesions
Detailed Description:
Primary Objectives
To assess the oral cancer free survival following intralesional injections of nivolumab in patients with high-risk oral premalignant lesions
Secondary Objectives
To describe the objective response rate ORR in index lesions following intralesional injections of nivolumab in patients with high-risk oral premalignant lesions according to modified World Health Organization WHO criteria
To describe the pathologic complete response CR rate in index lesions following intralesional injections of nivolumab in patients with high-risk oral premalignant lesions
To describe the major pathologic response rate in index lesions following intralesional injections of nivolumab in patients with high-risk oral premalignant lesions
To assess the oral cancer free survival following intralesional injections of nivolumab in patients with high-risk oral premalignant lesions
Secondary Objectives
To describe the objective response rate ORR in index lesions following intralesional injections of nivolumab in patients with high-risk oral premalignant lesions according to modified World Health Organization WHO criteria
To describe the pathologic complete response CR rate in index lesions following intralesional injections of nivolumab in patients with high-risk oral premalignant lesions
To describe the major pathologic response rate in index lesions following intralesional injections of nivolumab in patients with high-risk oral premalignant lesions
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