Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-01-01 @ 2:12 PM
Study NCT ID:
NCT04712851
Status:
RECRUITING
Last Update Posted:
2025-02-24
First Post:
2021-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pembrolizumab for the Treatment of Cervical Intraepithelial Neoplasia
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
A Phase II Open-Label, Single Arm Pilot Study to Evaluate the Safety and Efficacy of Pembrolizumab for High-Grade Cervical Intraepithelial Neoplasia
Status:
RECRUITING
Status Verified Date:
2025-02
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 phase II trial studies the effect of pembrolizumab on cervical intraepithelial neoplasia. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Detailed Description:
PRIMARY OBJECTIVE:
I. Proportion of subjects with pathologic complete response (no evidence of dysplasia).
SECONDARY OBJECTIVES:
I. Safety and tolerability of pembrolizumab in subjects with cervical intraepithelial neoplasia (CIN).
II. Proportion of subjects with pathologic partial response (regression to a lower grade of dysplasia).
EXPLORATORY OBJECTIVES:
I. Evaluation of Programmed Death-Ligand 1 (PD-L1) expression in CIN lesions as a biomarker of response to therapy.
II. Evaluation of Human Papillomavirus (HPV) status as a biomarker of response to therapy.
III. Evaluation of HPV clearance as a surrogate endpoint.
OUTLINE:
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 6 weeks for 4 cycles (24 weeks).
I. Proportion of subjects with pathologic complete response (no evidence of dysplasia).
SECONDARY OBJECTIVES:
I. Safety and tolerability of pembrolizumab in subjects with cervical intraepithelial neoplasia (CIN).
II. Proportion of subjects with pathologic partial response (regression to a lower grade of dysplasia).
EXPLORATORY OBJECTIVES:
I. Evaluation of Programmed Death-Ligand 1 (PD-L1) expression in CIN lesions as a biomarker of response to therapy.
II. Evaluation of Human Papillomavirus (HPV) status as a biomarker of response to therapy.
III. Evaluation of HPV clearance as a surrogate endpoint.
OUTLINE:
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 6 weeks for 4 cycles (24 weeks).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2020-11457 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |