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.
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
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
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.
Single group
Pembrolizumab
Biological/VaccineGiven IV
Pathological response rate
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)
Incidence of adverse events
PD-L1 expression
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.
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.
Will evaluate HPV clearance as a surrogate endpoint.
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Jonsson Comprehensive Cancer Center
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
