Loading clinical trials...

ACTIVE_NOT_RECRUITINGPHASE2

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

Phase II Study of Stereotactic Body Radiation Therapy and Atezolizumab in the Management of Recurrent, Persistent, or Metastatic Cervical Cancer

NCT03614949•H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

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

Locations (2)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Ohio State University - OSUMC - Wexner Medical Center

Hilliard, Ohio, United States

Key Dates

Start Date

January 29, 2019

Primary Completion Date

October 1, 2028

Completion Date

October 1, 2028

Last Updated

December 19, 2025

Enrollment

ACTUAL participants

Conditions

Cervical CancerCervical Cancer RecurrentCervical Cancer Metastatic

Interventions

Stereotactic body radiation therapy (SBRT)

RADIATION

Atezolizumab

DRUG

Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform

NCT06349642

Early Stage Triple-Negative Breast CarcinomaMetastatic Bladder Urothelial Carcinoma+25 more

View study

RECRUITINGPHASE1/PHASE2

E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers

NCT05639972

HPV-Associated Cervical CarcinomaHPV-Related Carcinoma+15 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform

E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers

Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR)

Secondary Cervical Cancer Prevention of Vulnerable Women With HPV and HIV Co-infection in India

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors

Rice Technologies for Cervical Cancer Screening and Diagnosis