Pembrolizumab for the Treatment of Cervical Intraepithelial Neoplasia (NCT04712851) | Clinical Trial Compass
RecruitingPhase 2
Pembrolizumab for the Treatment of Cervical Intraepithelial Neoplasia
United States25 participantsStarted 2021-06-30
Plain-language 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.
Who can participate
Age range21 Years
SexFEMALE
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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 (…