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

NCT ID: NCT03340376

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-30
• Study Completion Date: 2025-09-30

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

Conditions

Cervical Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

atezolizumab monotherapy

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

Group Type: EXPERIMENTAL

Atezolizumab

Intervention Type: DRUG

atezolizumab

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

Group Type: EXPERIMENTAL

Atezolizumab

Intervention Type: DRUG

atezolizumab

Doxorubicin

Intervention Type: DRUG

Doxorubicin

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

Group Type: ACTIVE_COMPARATOR

Doxorubicin

Intervention Type: DRUG

Doxorubicin

Interventions

Atezolizumab

atezolizumab

Intervention Type: DRUG

Doxorubicin

Doxorubicin

Intervention Type: DRUG

Eligibility 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Roche Pharma AG

INDUSTRY

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ignace Vergote, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

UZLeuven

Leuven, , Belgium

Countries

Belgium

Other Identifiers

BGOG-cx3

Identifier Type: -

Identifier Source: org_study_id