Doxorubicin Alone Versus Atezolizumab Alone Versus Doxorubicin and Atezolizumab in Recurrent Cervical Cancer

Study Overview
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Brief Summary
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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

Official Title
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Prospective Randomized Phase II Trial Comparing Doxorubicin Alone Versus Atezolizumab Alone Versus Doxorubicin and Atezolizumab in Recurrent Cervical Cancer

Conditions
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Cervical Cancer

Intervention / Treatment
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* Drug: Atezolizumab
* Drug: Doxorubicin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: atezolizumab monotherapy<br>A fixed dose of 1200 mg atezolizumab will be administered intravenously on Day 1 of each 21-day cycle until progressive disease | Drug: Atezolizumab<br>* atezolizumab<br>|
| Experimental: atezolizumab combined with doxorubicin<br>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<br>* atezolizumab<br>Drug: Doxorubicin<br>* Doxorubicin<br>|
| Active Comparator: doxorubicin monotherapy<br>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<br>* Doxorubicin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | after 9 months in the different arms by RECIST v1.1-criteria (doxorubicin, Atezolizumab and the combination of both) | after 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival in the different arms (doxorubicin, Atezolizumab and the combination of both) | after 24 months |