Prospective Randomized Phase II Trial Comparing Doxorubicin Alone Versus Atezolizumab Alone Versus Doxorubicin and Atezolizumab in Recurrent Cervical Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Progression free survival
Study Overview
Brief Summary
This is an open-label, multicenter, randomized phase II trial to evaluate the safety and efficacy of atezolizumab in patients with recurrent cervical cancer in second line therapy. A total of 48 patients will be randomized in 3 arms, each arm consisting of 16 patients:
Arm A: atezolizumab monotherapy q3w Arm B: atezolizumab combined with doxorubicin q3w Arm C: doxorubicin monotherapy q3w
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Squamous cell or adenocarcinoma of the cervix
- •At least one prior chemotherapy regimen for recurrent or advanced disease with a platinum-taxane combination, but not more than two lines of chemotherapy or targeted therapy in recurrent/advanced setting
- •Measurable disease
- •Adequate pretreatment hematologic, renal and hepatic function test
- •Patients are allowed to have had bevacizumab during their prior treatment
- •Evidence of non-childbearing status for women of childbearing potential
Exclusion Criteria
- •History of invasive malignancy other than cervical cancer unless there is no recurrence of these other primary tumors the last 3 years.
- •Previous anthracycline-based chemotherapy
- •Central nerve system metastases and leptomeningeal disease
- •Active or history of autoimmune disease
- •Prior allogenic bone marrow transplantation or prior solid organ transplantation
- •History of idiopathic pulmonary fibrosis
- •Known positive test for HIV, or active hepatitis B or hepatitis C
- •Known active tuberculosis
- •Severe infection within 4 weeks prior to initiation of study treatment
- •Prior immunotherapy
Arms & Interventions
atezolizumab monotherapy
A fixed dose of 1200 mg atezolizumab will be administered intravenously on Day 1 of each 21-day cycle until progressive disease
Intervention: Atezolizumab (Drug)
atezolizumab combined with doxorubicin
A fixed dose of 1200 mg atezolizumab will be administered intravenously on Day 1 of each 21-day cycle. Doxorubicin will be administered on Day 1 of each 21-day cycle at a dose of 75mg/m² for a total of 6 cycles or until progressive disease
Intervention: Atezolizumab (Drug)
atezolizumab combined with doxorubicin
A fixed dose of 1200 mg atezolizumab will be administered intravenously on Day 1 of each 21-day cycle. Doxorubicin will be administered on Day 1 of each 21-day cycle at a dose of 75mg/m² for a total of 6 cycles or until progressive disease
Intervention: Doxorubicin (Drug)
doxorubicin monotherapy
Doxorubicin will be administered on Day 1 of each 21-day cycle at a dose of 75mg/m² for a total of 6 cycles or until progressive disease
Intervention: Doxorubicin (Drug)
Outcomes
Primary Outcomes
Progression free survival
Time Frame: after 9 months
after 9 months in the different arms by RECIST v1.1-criteria (doxorubicin, Atezolizumab and the combination of both)
Secondary Outcomes
- Overall survival(after 24 months)