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

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ClinicalTrials.gov Identifier: NCT03614949
Recruitment Status : Recruiting
First Posted : August 3, 2018
Last Update Posted : August 17, 2021
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Tracking Information
First Submitted Date  ICMJE July 30, 2018
First Posted Date  ICMJE August 3, 2018
Last Update Posted Date August 17, 2021
Actual Study Start Date  ICMJE January 29, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2018)
Overall Response Rate (ORR) [ Time Frame: Up to 12 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2018)
  • Progression-free Survival (PFS) [ Time Frame: Up to 24 months ]
    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
  • Overall Survival (OS) [ Time Frame: Up to 24 months ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SBRT and Atezolizumab in the Management of Recurrent, Persistent, or Metastatic Cervical Cancer
Official Title  ICMJE Phase II Study of Stereotactic Body Radiation Therapy and Atezolizumab in the Management of Recurrent, Persistent, or Metastatic Cervical Cancer
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cervical Cancer
  • Cervical Cancer Recurrent
  • Cervical Cancer Metastatic
Intervention  ICMJE
  • Radiation: Stereotactic body radiation therapy (SBRT)
    SBRT with 24 Gy in 3 fractions to participants with ≥ 2 metastatic sites.
    Other Name: radiotherapy
  • Drug: Atezolizumab
    Atezolizumab 1200 mg intravenously (IV) every 3 weeks.
    Other Names:
    • Tecentriq®
    • immunotherapy
Study Arms  ICMJE Experimental: Combination Therapy
Stereotactic body radiation therapy (SBRT) followed by atezolizumab, 1 week later.
Interventions:
  • Radiation: Stereotactic body radiation therapy (SBRT)
  • Drug: Atezolizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 30, 2018)
26
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 HPV + squamous 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 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03614949
Other Study ID Numbers  ICMJE MCC-19662
ML40521 ( Other Identifier: Genentech )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party H. Lee Moffitt Cancer Center and Research Institute
Study Sponsor  ICMJE H. Lee Moffitt Cancer Center and Research Institute
Collaborators  ICMJE Genentech, Inc.
Investigators  ICMJE
Principal Investigator: Kamran Ahmed, M.D. H. Lee Moffitt Cancer Center and Research Institute
PRS Account H. Lee Moffitt Cancer Center and Research Institute
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP