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

• Status: Active, not recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitaire Ziekenhuizen Leuven
• Collaborator: Roche Pharma AG
• Treatments: Antibodies, Monoclonal; Atezolizumab; Doxorubicin; Liposomal doxorubicin

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