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
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer Cervical Cancer Recurrent Cervical Cancer Metastatic||Radiation: Stereotactic body radiation therapy (SBRT) Drug: Atezolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 29, 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2022|
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
Atezolizumab 1200 mg intravenously (IV) every 3 weeks.
- 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.
- 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.
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
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Elisa (Leece) Lemerond 813-745-2800 Elisa.Lemerond@moffitt.org|
|Contact: Kamran Ahmed, M.D. 813-745-3320 email@example.com|
|United States, Ohio|
|Ohio State University - OSUMC - Wexner Medical Center||Recruiting|
|Hilliard, Ohio, United States, 43026|
|Contact: Allison Quick, MD 614-293-3873 firstname.lastname@example.org|
|Contact: Corynn Mcatee email@example.com|
|Principal Investigator:||Kamran Ahmed, M.D.||H. Lee Moffitt Cancer Center and Research Institute|