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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
SBRT with 24 Gy in 3 fractions to participants with ≥ 2 metastatic sites.
Atezolizumab 1200 mg intravenously (IV) every 3 weeks.
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Ohio State University - OSUMC - Wexner Medical Center
Hilliard, Ohio, United States
Overall Response Rate (ORR)
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.
Time frame: Up to 5 years
Progression-free Survival (PFS)
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
Time frame: Up to 5 years
Overall Survival (OS)
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.
Time frame: Up to 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.