Pembrolizumab for the Treatment of Cervical Intraepithelial Neoplasia
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|ClinicalTrials.gov Identifier: NCT04712851|
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : August 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cervical Intraepithelial Neoplasia Cervical Squamous Cell Carcinoma In Situ Cervical Squamous Intraepithelial Neoplasia 2||Biological: Pembrolizumab||Phase 2|
I. Proportion of subjects with pathologic complete response (no evidence of dysplasia).
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).
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.
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 6 weeks for 4 cycles (24 weeks).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||June 30, 2021|
|Estimated Primary Completion Date :||January 31, 2023|
|Estimated Study Completion Date :||January 31, 2024|
Experimental: Treatment (pembrolizumab)
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 6 weeks for 4 cycles (24 weeks).
- Pathological response rate [ Time Frame: At 6 months ]Will assess the percent of patients with pathologic complete response at 6 months.
- Proportion of subjects with pathologic partial response (regression to a lower grade of dysplasia) [ Time Frame: Up to 6 months ]
- Incidence of adverse events [ Time Frame: Up to 6 months ]
- PD-L1 expression [ Time Frame: Up to 6 months ]Will correlate PD-L1 positivity with response to pembrolizumab.
- Assess percentage of subjects who respond to treatment who are HPV positive compared to percentage of subjects who respond to treatment who are HPV negative. [ Time Frame: Up to 6 months ]Assess percentage of subjects who respond to treatment who are HPV positive (using p16 positivity from pathology) compared to percentage of subjects who respond to treatment who are HPV negative in order to evaluate if HPV positivity correlates with improved response to treatment.
- Assess percentage of subjects with initial HPV infection who clear HPV infection (using p16 positivity from pathology) as a surrogate response to treatment evaluation. [ Time Frame: Up to 6 months ]Will evaluate HPV clearance as a surrogate endpoint.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04712851
|Contact: Maria Garcia-Jimenez, MD||310 209-0618||MGarciaJimenez@mednet.ucla.edu|
|Contact: Rosleen Mala||310 794-3879||RMala@mednet.ucla.edu|
|United States, California|
|University of California at Los Angeles / Jonsson Comprehensive Cancer Center||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Maria Garcia-Jimenez, MD 310-209-0618 firstname.lastname@example.org|
|Contact: Rosleen Mala 310 794-3879 RMala@mednet.ucla.edu|
|Principal Investigator: John A. Glaspy, MD|
|Principal Investigator:||John A Glaspy, MD||UCLA / Jonsson Comprehensive Cancer Center|