Status:
ACTIVE_NOT_RECRUITING
Doxorubicin Alone Versus Atezolizumab Alone Versus Doxorubicin and Atezolizumab in Recurrent Cervical Cancer
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18-100 years
Phase:
PHASE2
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 patie...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2025
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03340376
Start Date
August 30 2017
End Date
September 1 2025
Last Update
July 3 2024
Active Locations (1)
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1
UZLeuven
Leuven, Belgium, 3000