beta
Trial Radar AI
Clinical Trial NCT03340376 for Cervical Cancer is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

Doxorubicin Alone Versus Atezolizumab Alone Versus Doxorubicin and Atezolizumab in Recurrent Cervical Cancer Phase 2 48 Randomized Open-Label

Active, not recruiting
Clinical Trial NCT03340376 is designed to study Treatment for Cervical Cancer. It is a Phase 2 interventional study that is active, not recruiting, having started on 30 August 2017, with plans to enroll 48 participants. Led by Universitaire Ziekenhuizen KU Leuven, it is expected to complete by 1 September 2025. The latest data from ClinicalTrials.gov was last updated on 3 July 2024.
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

Official Title

Prospective Randomized Phase II Trial Comparing Doxorubicin Alone Versus Atezolizumab Alone Versus Doxorubicin and Atezolizumab in Recurrent Cervical Cancer

Conditions
Cervical Cancer
Other Study IDs
  • BGOG-cx3
NCT ID Number
NCT03340376
Start Date (Actual)
2017-08-30
Last Update Posted
2024-07-03
Completion Date (Estimated)
2025-09
Enrollment (Estimated)
48
Study Type
Interventional
PHASE
Phase 2
Status
Active, not recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Experimentalatezolizumab monotherapy
A fixed dose of 1200 mg atezolizumab will be administered intravenously on Day 1 of each 21-day cycle until progressive disease
Atezolizumab
atezolizumab
Experimentalatezolizumab 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
Atezolizumab
atezolizumab
Doxorubicin
Doxorubicin
Active Comparatordoxorubicin 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
Doxorubicin
Doxorubicin
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Progression free survival
after 9 months in the different arms by RECIST v1.1-criteria (doxorubicin, Atezolizumab and the combination of both)
after 9 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Overall survival
Overall survival in the different arms (doxorubicin, Atezolizumab and the combination of both)
after 24 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
  • 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

  • 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
Universitaire Ziekenhuizen KU Leuven logoUniversitaire Ziekenhuizen KU Leuven
No contact data.
1 Study Locations in 1 Countries
UZLeuven, Leuven, 3000, Belgium