Phase II Study of Atezolizumab + Bevacizumab in Endometrial 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: NCT03526432|
Recruitment Status : Recruiting
First Posted : May 16, 2018
Last Update Posted : July 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Drug: Bevacizumab Drug: Atezolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Single Arm Study of Atezolizumab + Bevacizumab in Women With Advanced, Recurrent or Persistent Endometrial Cancer|
|Actual Study Start Date :||August 8, 2018|
|Estimated Primary Completion Date :||May 25, 2021|
|Estimated Study Completion Date :||May 25, 2023|
|Experimental: Bevacizumab + Atezolizumab||
Bevacizumab will be administered by IV infusion at 15mg/kg on Day 1 of every 21-days cycle.
Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until disease progression, unacceptable toxicity, loss of clinical benefit as determined by the investigator.
- Number of patients who experience complete or partial tumor response [ Time Frame: 3 years ]To estimate the objective tumor response in women of this patient population
- Progression-free Survival [ Time Frame: up to 3 years ]To estimate progression-free survival (PFS) and overall survival (OS) of patients with recurrent or persistent endometrial cancer treated with Atezolizumab and Bevacizumab.
- Overall survival [ Time Frame: up to 3 years ]To estimate overall survival (OS) of patients with recurrent or persistent endometrial cancer treated with Atezolizumab and Bevacizumab.
- Number of patients who experience toxicity [ Time Frame: 6 months ]To determine the nature and degree of toxicity in combination of atezolizumab and bevacizumab.
- Number of participants who experience immune related response [ Time Frame: 6 months ]To estimate response using immune related response criteria (irRC) in patients receiving Atezolizumab and Bevacizumab.
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): NCT03526432
|Contact: Lead Gyn Onc Nurse||405 271-8777||SCC-IIT-Office@ouhsc.edu|
|United States, Alabama|
|UAB Women and Infants Center||Recruiting|
|Birmingham, Alabama, United States, 35233|
|Contact: Rebecca Arend, MD email@example.com|
|Principal Investigator: Rebecca Arend, MD|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63108|
|Contact: Carolyn McCourt, MD 314-362-3181 firstname.lastname@example.org|
|Principal Investigator: Carolyn McCourt, MD|
|United States, Oklahoma|
|Stephenson Cancer Center, University of Oklahoma Health Sciences Center||Recruiting|
|Oklahoma City, Oklahoma, United States, 73117|
|Contact: Lead Gyn Onc Nurse 405-271-8777 SCC-IIT-Office@ouhsc.edu|
|Principal Investigator:||Camille Gunderson, MD||Obstetrics and Gynecology|