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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03614949
Recruitment Status : Recruiting
First Posted : August 3, 2018
Last Update Posted : September 10, 2020
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Cervical Cancer Recurrent Cervical Cancer Metastatic Radiation: Stereotactic body radiation therapy (SBRT) Drug: Atezolizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Stereotactic Body Radiation Therapy and Atezolizumab in the Management of Recurrent, Persistent, or Metastatic Cervical Cancer
Actual Study Start Date : January 9, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Experimental: Combination Therapy
Stereotactic body radiation therapy (SBRT) followed by atezolizumab, 1 week later.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03614949


Locations
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United States, Florida
H. Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Mia Aoki    813-745-4377    mia.aoki@moffitt.org   
Contact: Kamran Ahmed, M.D.    813-745-3320    kamran.ahmed@moffitt.org   
United States, Ohio
Ohio State University - OSUMC - Wexner Medical Center Recruiting
Hilliard, Ohio, United States, 43026
Contact: Allison Quick, MD    614-293-3873    allison.quick@osumc.edu   
Contact: Corynn Mcatee       corynn.mcatee@osumc.edu   
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Genentech, Inc.
Investigators
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Principal Investigator: Kamran Ahmed, M.D. H. Lee Moffitt Cancer Center and Research Institute
Additional Information:
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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT03614949    
Other Study ID Numbers: MCC-19662
ML40521 ( Other Identifier: Genentech )
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
persistent cervical cancer
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Atezolizumab
Antineoplastic Agents