Doxorubicin Alone Versus Atezolizumab Alone Versus Doxorubicin and Atezolizumab in Recurrent Cervical Cancer
Overview
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
Full Title of Study: “Prospective Randomized Phase II Trial Comparing Doxorubicin Alone Versus Atezolizumab Alone Versus Doxorubicin and Atezolizumab in Recurrent Cervical Cancer”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: September 2021
Interventions
- Drug: Atezolizumab
- atezolizumab
- Drug: Doxorubicin
- Doxorubicin
Arms, Groups and Cohorts
- Experimental: atezolizumab monotherapy
- A fixed dose of 1200 mg atezolizumab will be administered intravenously on Day 1 of each 21-day cycle until progressive disease
- Experimental: 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
- Active Comparator: 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
Clinical Trial Outcome Measures
Primary Measures
- 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 Measures
- Overall survival
- Time Frame: after 24 months
- Overall survival in the different arms (doxorubicin, Atezolizumab and the combination of both)
Participating in This Clinical Trial
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 – ECOG≤2 – 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
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: 100 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Collaborator
- Roche Pharma AG
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Ignace Vergote, MD PhD, Principal Investigator, Universitaire Ziekenhuizen KU Leuven
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