Study on Using SBRT and Atezolizumab for Treating Recurrent, Persistent, or Metastatic Cervical Cancer

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03614949

This clinical trial is exploring whether combining a type of radiation therapy called SBRT with the immunotherapy drug atezolizumab can improve treatment outcomes for patients with cervical cancer that has returned, persisted, or spread to other parts of the body.

Patient Parameters

Program Overview

The aim of this study is to determine if adding stereotactic body radiation therapy (SBRT) to the immunotherapy drug atezolizumab can enhance the treatment response in patients with cervical cancer that has come back, continued, or spread. Researchers want to see if this combination is more effective than using atezolizumab alone.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a performance status that allows for daily activities with some limitations.
  • Have cervical cancer that has returned, persisted, or spread, including specific types like squamous cell, adenocarcinoma, and adenosquamous cancer, or p16+ cell cancer of the vagina or vulva.
  • Have measurable cancer that can be tracked using scans or clinical exams.
    • Previously treated areas can be included if the cancer has clearly grown since the last treatment.
    • Measurable tumors must be at least 1 cm in size as seen on scans or exams.
  • Have at least two separate tumors as shown by imaging tests within four weeks before starting the study.
  • Agree to a biopsy of the cancer or allow access to previous tissue samples.

Exclusion Criteria

  • Have known cancer spread to the brain.
  • Have active autoimmune diseases or immune deficiencies, such as lupus, rheumatoid arthritis, or multiple sclerosis, with some exceptions:
    • Patients with controlled hypothyroidism on hormone replacement are eligible.
    • Patients with controlled type 1 diabetes on insulin are eligible.
  • Have had another cancer within the last two years, except for certain low-risk cancers like non-melanoma skin cancer or early-stage uterine cancer.
  • Are taking or need to take medications that suppress the immune system, like steroids or certain other drugs, within two weeks before starting the study, with some exceptions:
    • Patients who have taken a short course of low-dose immunosuppressants or a single high dose for a specific reason.
    • Patients on certain medications for conditions like asthma or low blood pressure.

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