SBRT and Atezolizumab in the Management of Recurrent, Persistent, or Metastatic Cervical Cancer

H. Lee Moffitt Cancer Center and Research Institute logo

H. Lee Moffitt Cancer Center and Research Institute

Status and phase

Enrolling
Phase 2

Conditions

Cervical Cancer Metastatic
Cervical Cancer Recurrent
Cervical Cancer

Treatments

Drug: Atezolizumab
Radiation: Stereotactic body radiation therapy (SBRT)

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03614949
ML40521 (Other Identifier)
MCC-19662

Details and patient eligibility

About

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.

Enrollment

26 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
  • 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 > 90%), 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:

    • 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

26 participants in 1 patient group

Combination Therapy
Experimental group
Description:
Stereotactic body radiation therapy (SBRT) followed by atezolizumab, 1 week later.
Treatment:
Radiation: Stereotactic body radiation therapy (SBRT)
Drug: Atezolizumab

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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