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

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ClinicalTrials.gov Identifier: NCT03340376
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : May 22, 2018
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Tracking Information
First Submitted Date  ICMJE April 5, 2017
First Posted Date  ICMJE November 13, 2017
Last Update Posted Date May 22, 2018
Actual Study Start Date  ICMJE August 30, 2017
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2017)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03340376 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2017)
Overall survival [ Time Frame: after 24 months ]
Overall survival in the different arms (doxorubicin, Atezolizumab and the combination of both)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Doxorubicin Alone Versus Atezolizumab Alone Versus Doxorubicin and Atezolizumab in Recurrent Cervical Cancer
Official Title  ICMJE Prospective Randomized Phase II Trial Comparing Doxorubicin Alone Versus Atezolizumab Alone Versus Doxorubicin and Atezolizumab in Recurrent Cervical Cancer
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cervical Cancer
Intervention  ICMJE
  • Drug: Atezolizumab
    atezolizumab
  • Drug: Doxorubicin
    Doxorubicin
Study Arms  ICMJE
  • 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
    Intervention: Drug: Atezolizumab
  • 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
    Interventions:
    • Drug: Atezolizumab
    • Drug: Doxorubicin
  • 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
    Intervention: Drug: Doxorubicin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 8, 2017)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Joke De Roover, PhD +3216347419 bgog@engot.eu
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03340376
Other Study ID Numbers  ICMJE BGOG-cx3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Universitaire Ziekenhuizen Leuven
Study Sponsor  ICMJE Universitaire Ziekenhuizen Leuven
Collaborators  ICMJE Roche Pharma AG
Investigators  ICMJE
Principal Investigator: Ignace Vergote, MD PhD Universitaire Ziekenhuizen Leuven
PRS Account Universitaire Ziekenhuizen Leuven
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP