Phase II Study of Stereotactic Body Radiation Therapy and Atezolizumab in the Management of Recurrent, Persistent, or Metastatic Cervical Cancer

  • End date
    Dec 11, 2023
  • participants needed
  • sponsor
    H. Lee Moffitt Cancer Center and Research Institute
Updated on 11 October 2022
measurable disease
squamous cell carcinoma
human papilloma virus vaccine
metastatic cervical cancer


The purpose of this study is to see if treatment with atezolizumab and stereotactic body radiation therapy (SBRT) will improve the objective response rate (ORR) compared with atezolizumab alone in patients with recurrent, persistent, or metastatic cervical cancer.

Condition Cervical Cancer, Cervical Cancer Recurrent, Cervical Cancer Metastatic
Treatment Stereotactic Body Radiation Therapy (SBRT), Atezolizumab
Clinical Study IdentifierNCT03614949
SponsorH. Lee Moffitt Cancer Center and Research Institute
Last Modified on11 October 2022


Yes No Not Sure

Inclusion Criteria

At least 18 years of age
Eastern Cooperative Oncology Group (ECOG) ≤ 2 or Karnofsky Performance Status of ≥ 60
Participants must have recurrent, persistent, or metastatic cervical cancer, including squamous cell, adenocarcinoma, and adenosquamous histologies recurrent, persistent, or metastatic p16+ cell cancer of the vagina or vulva
Measurable disease per irRECIST
Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation
Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥10 mm (≥1 cm) with computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
Must have at least 2 distinct lesions as documented by imaging studies within 4 weeks
prior to randomization
Consent to biopsy of metastatic site or consent to retrieval of archival tissue

Exclusion Criteria

Patients with known brain metastasis
Active autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, autoimmune thyroid disease, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis with the following exceptions
Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study
Patients with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study
Patients with stable and well controlled rheumatoid arthritis at the discretion of the treating physician
History of prior malignancy within 2 years prior to screening, with the exception of
those with a negligible risk of metastasis or death (e.g., 5-year OS of >
Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy)
Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency
%), such as but not limited to, non-melanoma skin carcinoma, ductal
carcinoma in situ, or stage I endometrioid uterine cancer, and others at the
discretion of the Principal Investigator (PI)
Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (TNF)-α agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study, with the following exceptions
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How to participate?

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What happens next?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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