Doxorubicin Alone Versus Atezolizumab Alone Versus Doxorubicin and Atezolizumab in Recurrent Cervical Cancer
NCT03340376 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2024-07-03
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
Interventions
- DRUG
-
atezolizumab
- DRUG
-
Doxorubicin
Doxorubicin
Sponsors & Collaborators
-
Roche Pharma AG
collaborator INDUSTRY -
Universitaire Ziekenhuizen KU Leuven
lead OTHER
Principal Investigators
-
Ignace Vergote, MD PhD · Universitaire Ziekenhuizen KU Leuven
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 100 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-08-30
- Primary Completion
- 2025-09-30
- Completion
- 2025-09-30
Countries
- Belgium
Study Locations
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