Study on Chemoradiotherapy With or Without Pembrolizumab for Treating Locally Advanced Cervical Cancer

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04221945

Provider View

This clinical trial is testing whether adding the drug pembrolizumab to standard chemoradiotherapy can improve treatment outcomes for women with locally advanced cervical cancer. The study aims to compare the effectiveness and safety of this combination against standard treatment alone.

Patient Parameters

Program Overview

The purpose of this study is to find out if combining pembrolizumab with standard chemoradiotherapy is more effective than using chemoradiotherapy alone for treating locally advanced cervical cancer. Researchers are looking to see if this combination can help patients live longer without the cancer getting worse. Once the main goals of the study are achieved or the study ends, participants will move to an extension study for continued assessments and treatment.

Eligibility Criteria

Inclusion Criteria

  • Have high-risk locally advanced cervical cancer (LACC) at specific stages as defined by medical guidelines.
  • Have a confirmed diagnosis of certain types of cervical cancer, such as squamous cell carcinoma or adenocarcinoma.
  • Have not received any previous major treatments for cervical cancer, including surgery, radiation, or systemic therapy.
  • Female participants must not be pregnant or breastfeeding and must agree to use effective birth control during the study and for a specified period after treatment.
  • Must not donate eggs during the study and for a specified period after treatment.
  • Have a good overall health status, with a performance score of 0 or 1.
  • Have provided a tissue sample from a tumor biopsy.
  • Have disease that can be evaluated by scans, either measurable or non-measurable.
  • Have adequate organ function as determined by specific medical tests.

Exclusion Criteria

  • Have certain subtypes of locally advanced cervical cancer that are not included in the study.
  • Have cervical cancer that has spread to distant organs (Stage IVB).
  • Have had a hysterectomy or will have one as part of initial treatment.
  • Have certain kidney issues unless resolved or considered mild.
  • Have conditions that prevent certain types of radiation therapy.
  • Have received a live vaccine within 30 days before starting the study.
  • Have used certain immune-boosting treatments recently.
  • Have had previous treatments with specific immune therapies.
  • Are currently in another clinical trial or have used investigational treatments recently.
  • Have any contraindications to using the chemotherapy drug cisplatin.
  • Have a weakened immune system or are on high-dose steroids or other immune-suppressing treatments.
  • Have another active cancer that required treatment in the past 3 years.
  • Have severe allergies to pembrolizumab or its ingredients.
  • Have an active autoimmune disease needing treatment in the past 2 years.
  • Have a history of lung disease requiring steroids or current lung disease.
  • Have an active infection needing treatment.
  • Have a history of HIV, Hepatitis B, or active Hepatitis C.
  • Have any condition or treatment that could increase risks or interfere with study results.
  • Have a psychiatric or substance abuse disorder affecting study participation.
  • Have had a tissue or organ transplant.
  • Have evidence of cancer spread to certain lymph nodes.

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