Actively Recruiting
Pembrolizumab for the Treatment of Cervical Intraepithelial Neoplasia
Led by Jonsson Comprehensive Cancer Center · Updated on 2026-03-10
25
Participants Needed
1
Research Sites
343 weeks
Total Duration
On this page
Sponsors
J
Jonsson Comprehensive Cancer Center
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pembrolizumab for the Treatment of Cervical Intraepithelial Neoplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 21 years or older with active, histologically confirmed CIN grade 2 or 3, or carcinoma in situ without invasive cancer
- Female participants who are not pregnant or breastfeeding
- Women not of childbearing potential or women of childbearing potential willing to use contraception during treatment and for 120 days after last dose
- Ability to provide written informed consent
- Availability of archival or newly obtained tumor tissue samples suitable for analysis
- Willingness to consent to a biopsy after cycle 2 if lesion is accessible and biopsy is safe
- Willingness to consent to loop electrode excision procedure or cold-knife cone surgery after 24 weeks, unless surgery is contraindicated
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Normal organ function based on lab tests within 10 days prior to treatment start, except pregnancy test within 72 hours before first treatment
You will not qualify if you...
- Positive pregnancy test within 72 hours before treatment start
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 agents, or other immune checkpoint therapies
- Prior systemic therapy for CIN including investigational agents within 4 weeks before treatment
- Prior radiotherapy within 2 weeks before treatment start
- Receipt of live vaccines within 30 days before first dose
- Current participation in another investigational study or recent use of investigational devices within 4 weeks
- Immunodeficiency or use of systemic immunosuppressive therapy exceeding 10 mg prednisone equivalent within 7 days before treatment
- History of second malignancy unless cured and no evidence of disease for 2 years
- Severe hypersensitivity to pembrolizumab or its ingredients
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or current pneumonitis requiring steroids
- Active infection needing systemic therapy
- Known HIV infection
- Known active hepatitis B or C infection
- Known active tuberculosis
- Conditions or therapies that could interfere with study participation or results
- Psychiatric or substance abuse disorders interfering with trial cooperation
- Pregnant, breastfeeding, or planning to conceive/father children during study and 120 days afterward
- History of allogenic tissue or solid organ transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of California at Los Angeles / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Actively Recruiting
Research Team
M
Maria Garcia-Jimenez, MD
CONTACT
R
Rosleen Mala
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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