Doxorubicin Alone Versus Atezolizumab Alone Versus Doxorubicin and Atezolizumab in Recurrent Cervical Cancer
Study Details
Study Description
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
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
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 |
Drug: Atezolizumab
atezolizumab
|
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 |
Drug: Atezolizumab
atezolizumab
Drug: Doxorubicin
Doxorubicin
|
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 |
Drug: Doxorubicin
Doxorubicin
|
Outcome Measures
Primary Outcome Measures
- Progression free survival [after 9 months]
after 9 months in the different arms by RECIST v1.1-criteria (doxorubicin, Atezolizumab and the combination of both)
Secondary Outcome Measures
- Overall survival [after 24 months]
Overall survival in the different arms (doxorubicin, Atezolizumab and the combination of both)
Eligibility Criteria
Criteria
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
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ECOG≤2
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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.
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Previous anthracycline-based chemotherapy
-
Central nerve system metastases and leptomeningeal disease
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Active or history of autoimmune disease
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Prior allogenic bone marrow transplantation or prior solid organ transplantation
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History of idiopathic pulmonary fibrosis
-
Known positive test for HIV, or active hepatitis B or hepatitis C
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Known active tuberculosis
-
Severe infection within 4 weeks prior to initiation of study treatment
-
Prior immunotherapy
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | UZLeuven | Leuven | Belgium | 3000 |
Sponsors and Collaborators
- Universitaire Ziekenhuizen Leuven
- Roche Pharma AG
Investigators
- Principal Investigator: Ignace Vergote, MD PhD, Universitaire Ziekenhuizen Leuven
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BGOG-cx3