Loading clinical trials...

Pembrolizumab for the Treatment of Cervical Intraepithelial Neoplasia | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Pembrolizumab for the Treatment of Cervical Intraepithelial Neoplasia

A Phase II Open-Label, Single Arm Pilot Study to Evaluate the Safety and Efficacy of Pembrolizumab for High-Grade Cervical Intraepithelial Neoplasia

NCT04712851•Jonsson Comprehensive Cancer Center

View on ClinicalTrials.gov

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).

Eligibility

Age

21 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Female participants who are at least 21 years of age on the day of signing informed consent with active (not yet resected), histologically confirmed diagnosis of CIN grade 2 or 3 or carcinoma in situ (without invasive component) will be enrolled in this study. Subjects with multifocal disease are acceptable
•A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
•* Not a woman of childbearing potential (WOCBP) OR
•* A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment
•The participant (or legally acceptable representative if applicable) provides written informed consent for the trial
•Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue
•Participants must be willing to consent to mid-study biopsy after cycle 2 of treatment if there is an accessible lesion and biopsy is not contraindicated
•Participants must be willing to consent to either loop electrode excision procedure (LEEP) or cold-knife cone (CKC) at the end of treatment (i.e., after 24 weeks on study), unless surgery is contraindicated at that time
•Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
•Have normal organ function (with all baseline laboratory assessments in the normal range). Specimens must be collected within 10 days prior to the start of study treatment, except for pregnancy test which must be within 72 hours of cycle 1 of treatment

Exclusion Criteria

•A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
•* Note: in the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication
•Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137)
•Has received prior systemic therapy for CIN including investigational agents within the prior 4 weeks \[could consider shorter interval for short half-life drugs\] prior to allocation.
•* Note: Participants must have recovered from all adverse events (AEs) due to previous therapies to =\< grade 1 or baseline. Participants with =\< grade 2 neuropathy may be eligible.
•* Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment
•Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=\< 2 weeks of radiotherapy) to non-central nervous system (CNS) disease
•Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed
•Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
•* Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent
+15 more criteria

Locations (1)

University of California at Los Angeles / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Key Dates

Start Date

June 30, 2021

Primary Completion Date

January 31, 2027

Completion Date

January 31, 2028

Last Updated

March 10, 2026

Enrollment

ESTIMATED participants

Conditions

Cervical Intraepithelial NeoplasiaCervical Squamous Cell Carcinoma In SituCervical Squamous Intraepithelial Neoplasia 2

Interventions

Pembrolizumab

BIOLOGICAL

Contacts

Maria Garcia-Jimenez, MD

CONTACT

310 209-0618 MGarciaJimenez@mednet.ucla.edu

Rosleen Mala

CONTACT

310 794-3879 RMala@mednet.ucla.edu

Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV

NCT05266898

Papillomavirus VaccinesHuman Immunodeficiency Virus+5 more

View study

RECRUITING

Conservative Management of HSIL in Patients With Future Pregnancy Aspiration

NCT04783805

Cervical Intraepithelial NeoplasiaSquamous Intraepithelial Lesions of the Cervix+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Pembrolizumab for the Treatment of Cervical Intraepithelial Neoplasia

Inclusion Criteria

Exclusion Criteria

Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV

Conservative Management of HSIL in Patients With Future Pregnancy Aspiration

Local Hyperthermia for the Treatment of Cervical Persistent High-risk Infection

Compass - Randomised Controlled Trial of Primary HPV Testing for Cervical Screening in Australia

Effectiveness of Cervical Screening in HPV Vaccinated Women

Randomized Implementation of Primary HPV Testing in the Organized Screening for Cervical Cancer in Stockholm