Clinical Trials /

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

NCT03614949

Description:

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.

Related Conditions:
  • Cervical Adenocarcinoma
  • Cervical Adenosquamous Carcinoma
  • Cervical Carcinoma
  • Cervical Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: SBRT and Atezolizumab in the Management of Recurrent, Persistent, or Metastatic Cervical Cancer
  • Official Title: Phase II Study of Stereotactic Body Radiation Therapy and Atezolizumab in the Management of Recurrent, Persistent, or Metastatic Cervical Cancer

Clinical Trial IDs

  • ORG STUDY ID: MCC-19662
  • SECONDARY ID: ML40521
  • NCT ID: NCT03614949

Conditions

  • Cervical Cancer
  • Cervical Cancer Recurrent
  • Cervical Cancer Metastatic

Interventions

DrugSynonymsArms
AtezolizumabTecentriq®, immunotherapyCombination Therapy

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Combination TherapyExperimentalStereotactic body radiation therapy (SBRT) followed by atezolizumab, 1 week later.
  • Atezolizumab

Eligibility Criteria

        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

          -  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 or history of 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Response Rate (ORR)
Time Frame:Up to 12 months
Safety Issue:
Description:ORR by Immune-Modified Response Evaluation Criteria in Solid Tumors (irRECIST) criteria of SBRT and atezolizumab in the management of recurrent/persistent/metastatic cervical cancer. Complete Response (CR): Disappearance of all lesions; Partial Response (PR): ≥30% decrease in tumor burden, a in the absence of CR; Progressive Disease (PD): ≥20% increase in tumor burden; Stable Disease (SD): Neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD.

Secondary Outcome Measures

Measure:Progression-free Survival (PFS)
Time Frame:Up to 24 months
Safety Issue:
Description:PFS following combined modality management with SBRT and atezolizumab in the management of recurrent/persistent/metastatic cervical cancer. PFS: Time from the date of start of treatment to the investigator-determined date of progression (determined by irRECIST criteria) or death due to any cause, whichever occurs first. Progressive Disease (PD): ≥20% increase in tumor burden
Measure:Overall Survival (OS)
Time Frame:Up to 24 months
Safety Issue:
Description:OS following combined modality management with SBRT and atezolizumab in the management of recurrent/persistent/metastatic cervical cancer. OS: Time from the date of start of treatment to death.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:H. Lee Moffitt Cancer Center and Research Institute

Trial Keywords

  • persistent cervical cancer

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