This is a single arm, Phase II study using the combination of atezolizumab and bevicacizumab in women with advanced, recurrent or persistent endometrial cancer. Safety and futility of this drug combination will be assessed to see what effect this treatment has on this patient population.
This phase 2 study using atezolizumab and bevacizumab aims to study the objective tumor response in women with recurrent endometrial cancer. Drugs will be administered via IV every 21 days until disease progression, unacceptable toxicity, or loss of clinical benefit as determined by investigator. Subjects will receive routine cancer care as well as tests and procedures required for the purposes of this study. It is expected this combination will be produce an anti-cancer effect with manageable toxicities in this patient population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
110
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.
UAB Women and Infants Center
Birmingham, Alabama, United States
Washington University School of Medicine
St Louis, Missouri, United States
Stephenson Cancer Center, University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Number of patients who experience complete or partial tumor response
To estimate the objective tumor response in women of this patient population
Time frame: 3 years
Progression-free Survival
To estimate progression-free survival (PFS) and overall survival (OS) of patients with recurrent or persistent endometrial cancer treated with Atezolizumab and Bevacizumab.
Time frame: up to 3 years
Overall survival
To estimate overall survival (OS) of patients with recurrent or persistent endometrial cancer treated with Atezolizumab and Bevacizumab.
Time frame: up to 3 years
Number of patients who experience toxicity
To determine the nature and degree of toxicity in combination of atezolizumab and bevacizumab.
Time frame: 6 months
Number of participants who experience immune related response
To estimate response using immune related response criteria (irRC) in patients receiving Atezolizumab and Bevacizumab.
Time frame: 6 months
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