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

Overview

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

Full Title of Study: “Prospective Randomized Phase II Trial Comparing Doxorubicin Alone Versus Atezolizumab Alone Versus Doxorubicin and Atezolizumab in Recurrent Cervical Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2021

Interventions

  • Drug: Atezolizumab
    • atezolizumab
  • Drug: Doxorubicin
    • Doxorubicin

Arms, Groups and Cohorts

  • Experimental: atezolizumab monotherapy
    • A fixed dose of 1200 mg atezolizumab will be administered intravenously on Day 1 of each 21-day cycle until progressive disease
  • Experimental: 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
  • Active Comparator: 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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Overall survival
    • Time Frame: after 24 months
    • Overall survival in the different arms (doxorubicin, Atezolizumab and the combination of both)

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universitaire Ziekenhuizen KU Leuven
  • Collaborator
    • Roche Pharma AG
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ignace Vergote, MD PhD, Principal Investigator, Universitaire Ziekenhuizen KU Leuven

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