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

Universitaire Ziekenhuizen KU Leuven

Status and phase: Active, not recruiting; Phase 2

Conditions: Cervical Cancer

Treatments: Drug: Doxorubicin; Drug: Atezolizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03340376

BGOG-cx3

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 3 patient groups

atezolizumab monotherapy

Experimental group

Description:

A fixed dose of 1200 mg atezolizumab will be administered intravenously on Day 1 of each 21-day cycle until progressive disease

Treatment:

Drug: Atezolizumab

atezolizumab combined with doxorubicin

Experimental group

Description:

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

Treatment:

Drug: Atezolizumab

Drug: Doxorubicin

doxorubicin monotherapy

Active Comparator group

Description:

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

Treatment:

Drug: Doxorubicin