Actively Recruiting
A Phase II Open-Label, Single Arm Pilot Study to Evaluate the Safety and Efficacy of Pembrolizumab for High-Grade Cervical Intraepithelial Neoplasia
Led by Jonsson Comprehensive Cancer Center · Updated on 2026-03-10
25
Participants Needed
1
Research Sites
52 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
Researchers are evaluating pembrolizumab, an immunotherapy drug, for treating cervical intraepithelial neoplasia (CIN), a precancerous condition of the cervix. This phase II trial aims to study the safety and effectiveness of pembrolizumab in helping the body's immune system fight abnormal cell growth in high-grade CIN, including carcinoma in situ without invasive cancer. The study also explores biomarkers like PD-L1 expression and HPV status to understand responses to the treatment. Participants receive pembrolizumab administered intravenously over 30 minutes on day 1, repeating every 6 weeks for a total of 4 cycles lasting 24 weeks. The treatment phase is followed by assessments including a biopsy after the second cycle and a surgical procedure such as loop electrode excision or cold-knife cone at the end of treatment, unless surgery is contraindicated. The study is open-label and single-arm, focusing solely on pembrolizumab without a comparison group. During the study, participants undergo multiple evaluations including pathological assessments to measure complete or partial responses of the cervical lesions at 6 months. Safety and tolerability are closely monitored through adverse event tracking. Participants must provide tissue samples before and during the study, and their health status, organ functions, and pregnancy status are regularly assessed. The total participation duration covers the 24 weeks of treatment with follow-up evaluations up to 6 months to observe treatment outcomes and side effects.
CONDITIONS
Brief 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
- Histologically confirmed diagnosis of CIN grade 2 or 3 or carcinoma in situ without invasive component
- Female participants who are not pregnant or breastfeeding
- Women of childbearing potential must agree to use contraception during treatment and for 120 days after last dose, or be not of childbearing potential
- Ability to provide informed consent
- Provision of archival or newly obtained tumor tissue biopsy
- Willingness to consent to mid-study biopsy after cycle 2 if lesion accessible
- Willingness to consent to loop electrode excision procedure (LEEP) or cold-knife cone (CKC) at end of treatment unless contraindicated
- ECOG performance status of 0 to 1
- Normal organ function with baseline lab assessments within normal range
You will not qualify if you...
- Positive pregnancy test within 72 hours prior to treatment start for women of childbearing potential
- Prior therapy with anti-PD-1, anti-PD-L1, or similar immunotherapy agents
- Prior systemic therapy for CIN including investigational agents within 4 weeks before treatment
- Prior radiotherapy within 2 weeks before treatment
- Receipt of live vaccine within 30 days prior to first dose
- Participation in another investigational study within 4 weeks prior to treatment
- Diagnosis of immunodeficiency or use of systemic immunosuppressive therapy exceeding 10 mg prednisone daily within 7 days prior
- History of second malignancy unless treated and no evidence of disease for 2 years
- Severe hypersensitivity to pembrolizumab or its components
- Active autoimmune disease requiring systemic treatment within past 2 years
- History or current pneumonitis requiring steroids
- Active infection requiring systemic therapy
- Known HIV infection
- Known active hepatitis B or C infection
- Active tuberculosis
- Conditions, treatments, or lab abnormalities interfering with study participation
- Psychiatric or substance abuse disorders interfering with trial cooperation
- Pregnancy, breastfeeding, or expecting to conceive within study duration plus 120 days
- History of allogenic tissue or solid organ transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 24 weeks
Participants receive pembrolizumab intravenously over 30 minutes on day 1, repeated every 6 weeks for 4 cycles.
4 visits (in-person) for treatment administration every 6 weeks
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
R
Rosleen Mala
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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