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

Phase 2

Active, not recruiting

• Conditions: Cervical Cancer
• Interventions: Drug: Atezolizumab; Drug: Doxorubicin

• Registration Number: NCT03340376
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-05
• Study Start: 2017-08-30
• Study First Submitted QC: 2017-11-08
• Study First Posted: 2017-11-13
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
atezolizumab monotherapy	Atezolizumab	A fixed dose of 1200 mg atezolizumab will be administered intravenously on Day 1 of each 21-day cycle until progressive disease
atezolizumab combined with doxorubicin	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
atezolizumab combined with doxorubicin	Atezolizumab	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
doxorubicin monotherapy	Doxorubicin	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Overall survival	after 24 months	Overall survival in the different arms (doxorubicin, Atezolizumab and the combination of both)

Trial Locations

Locations (1)

UZLeuven; 🇧🇪 Leuven, Belgium