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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

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


Condition or disease Intervention/treatment Phase
Cervical Cancer Drug: Atezolizumab Drug: Doxorubicin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Phase II Trial Comparing Doxorubicin Alone Versus Atezolizumab Alone Versus Doxorubicin and Atezolizumab in Recurrent Cervical Cancer
Actual Study Start Date : August 30, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
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
Drug: Atezolizumab
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
Drug: Atezolizumab
atezolizumab

Drug: Doxorubicin
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
Drug: Doxorubicin
Doxorubicin




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Overall survival [ Time Frame: after 24 months ]
    Overall survival in the different arms (doxorubicin, Atezolizumab and the combination of both)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03340376


Contacts
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Contact: Joke De Roover, PhD +3216347419 bgog@engot.eu

Locations
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Belgium
UZLeuven Recruiting
Leuven, Belgium, 3000
Contact: Joke De Roover    +3216347419    joke.deroover@uzleuven.be   
Sub-Investigator: Ignace Vergote         
Principal Investigator: Rawand Salihi         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Roche Pharma AG
Investigators
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Principal Investigator: Ignace Vergote, MD PhD Universitaire Ziekenhuizen Leuven

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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03340376     History of Changes
Other Study ID Numbers: BGOG-cx3
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Doxorubicin
Liposomal doxorubicin
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Atezolizumab
Antibodies, Monoclonal
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs