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

Phase 2

Recruiting

• Conditions: Cervical Cancer; Cervical Cancer Recurrent; Cervical Cancer Metastatic

• Registration Number: NCT03614949
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-7-30
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 26

Inclusion Criteria

Inclusion Criteria:<br><br> - At least 18 years of age<br><br> - Eastern Cooperative Oncology Group (ECOG) = 2 or Karnofsky Performance Status of =<br> 60<br><br> - Participants must have recurrent, persistent, or metastatic cervical cancer,<br> including squamous cell, adenocarcinoma, and adenosquamous histologies recurrent,<br> persistent, or metastatic p16+ cell cancer of the vagina or vulva<br><br> - Measurable disease per irRECIST<br><br> - Previously irradiated lesions can be considered as measurable disease only if<br> progressive disease has been unequivocally documented at that site since<br> radiation<br><br> - Measurable lesions are defined as those that can be accurately measured in at<br> least one dimension (longest diameter to be recorded) as =10 mm (=1 cm) with<br> computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by<br> clinical exam.<br><br> - Must have at least 2 distinct lesions as documented by imaging studies within 4<br> weeks prior to randomization<br><br> - Consent to biopsy of metastatic site or consent to retrieval of archival tissue<br><br>Exclusion Criteria:<br><br> - Patients with known brain metastasis<br><br> - Active autoimmune disease or immune deficiency, including, but not limited to,<br> myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus,<br> rheumatoid arthritis, autoimmune thyroid disease, inflammatory bowel disease,<br> antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren's syndrome,<br> Guillain-Barré syndrome, or multiple sclerosis with the following exceptions:<br><br> - Patients with a history of autoimmune-related hypothyroidism who are on<br> thyroid-replacement hormone are eligible for the study<br><br> - Patients with controlled type 1 diabetes mellitus who are on an insulin regimen<br> are eligible for the study<br><br> - History of prior malignancy within 2 years prior to screening, with the exception of<br> those with a negligible risk of metastasis or death (e.g., 5-year OS of > 90%), such<br> as but not limited to, non-melanoma skin carcinoma, ductal carcinoma in situ, or<br> stage I endometrioid uterine cancer, and others at the discretion of the Principal<br> Investigator (PI)<br><br> - Treatment with systemic immunosuppressive medication (including, but not limited to,<br> corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and<br> anti-tumor necrosis factor (TNF)-a agents) within 2 weeks prior to initiation of<br> study treatment, or anticipation of need for systemic immunosuppressive medication<br> during the course of the study, with the following exceptions:<br><br> - Patients who received acute, low-dose systemic immunosuppressant medication or<br> a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours<br> of corticosteroids for a contrast allergy)<br><br> - Patients who received mineralocorticoids (e.g., fludrocortisone),<br> corticosteroids for chronic obstructive pulmonary disease or asthma, or<br> low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS);Overall Survival (OS)