Study on Pembrolizumab for Treating Cervical Pre-Cancerous Lesions

Sponsor: Jonsson Comprehensive Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04712851

Provider View

This clinical trial is exploring the use of pembrolizumab, an immunotherapy drug, to treat cervical intraepithelial neoplasia (CIN), a condition that can lead to cervical cancer. The study aims to see if pembrolizumab can help the immune system fight these pre-cancerous cells and prevent them from growing and spreading.

Patient Parameters

Program Overview

This phase II study is testing pembrolizumab, a type of immunotherapy, to see if it can help the body's immune system attack and reduce cervical intraepithelial neoplasia (CIN), which are pre-cancerous lesions in the cervix. The study will evaluate how well the treatment works and its safety for patients.

Description

The main goal of this study is to see how many patients have a complete response, meaning no signs of pre-cancerous cells after treatment with pembrolizumab. The study will also look at how safe and tolerable pembrolizumab is for patients with cervical intraepithelial neoplasia (CIN). Additionally, researchers will assess how many patients have a partial response, where the pre-cancerous cells decrease in severity.

The study will explore whether certain markers, like PD-L1 expression and HPV status, can predict how well patients respond to the treatment. Patients will receive pembrolizumab through an IV every six weeks for a total of four cycles, lasting 24 weeks.

Eligibility Criteria

Inclusion Criteria

  • Women aged 21 or older with a confirmed diagnosis of CIN grade 2 or 3, or carcinoma in situ (without invasive cancer).
  • Must not be pregnant or breastfeeding and must agree to use effective birth control during the study and for 120 days after the last dose if of childbearing potential.
  • Must provide a tumor tissue sample for analysis.
  • Must agree to a mid-study biopsy if possible and a surgical procedure at the end of treatment unless medically advised against it.
  • Must have a good performance status, meaning they are fully active or have some restrictions but can still do light work.
  • Must have normal organ function based on lab tests done within 10 days before starting the study.

Exclusion Criteria

  • Women who are pregnant or breastfeeding.
  • Have had previous treatment with similar immunotherapy drugs.
  • Have had other treatments for CIN within the last four weeks.
  • Have had recent radiotherapy or a live vaccine within 30 days before starting the study.
  • Are currently in another clinical trial or have been in one within the last four weeks.
  • Have a weakened immune system or are on high-dose steroids or other immunosuppressive drugs.
  • Have a history of another cancer unless treated and cancer-free for two years.
  • Have severe allergies to pembrolizumab or its ingredients.
  • Have active autoimmune diseases requiring treatment in the past two years.
  • Have a history of lung inflammation or current lung issues.
  • Have active infections needing treatment.
  • Have a history of HIV, hepatitis B, hepatitis C, or tuberculosis.
  • Have any condition that might interfere with the study or are not in the best interest to participate.
  • Have psychiatric or substance abuse issues that would affect participation.
  • Have had an organ transplant.

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