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

Primary Purpose

Cervical Cancer

Status
Unknown status
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Atezolizumab
Doxorubicin
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • UZLeuven

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

atezolizumab monotherapy

atezolizumab combined with doxorubicin

doxorubicin monotherapy

Arm Description

A fixed dose of 1200 mg atezolizumab will be administered intravenously on Day 1 of each 21-day cycle until progressive disease

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

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

Outcomes

Primary Outcome Measures

Progression free survival
after 9 months in the different arms by RECIST v1.1-criteria (doxorubicin, Atezolizumab and the combination of both)

Secondary Outcome Measures

Overall survival
Overall survival in the different arms (doxorubicin, Atezolizumab and the combination of both)

Full Information

First Posted
April 5, 2017
Last Updated
January 26, 2021
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Roche Pharma AG
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1. Study Identification

Unique Protocol Identification Number
NCT03340376
Brief Title
Doxorubicin Alone Versus Atezolizumab Alone Versus Doxorubicin and Atezolizumab in Recurrent Cervical Cancer
Official Title
Prospective Randomized Phase II Trial Comparing Doxorubicin Alone Versus Atezolizumab Alone Versus Doxorubicin and Atezolizumab in Recurrent Cervical Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 30, 2017 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Roche Pharma AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
atezolizumab monotherapy
Arm Type
Experimental
Arm Description
A fixed dose of 1200 mg atezolizumab will be administered intravenously on Day 1 of each 21-day cycle until progressive disease
Arm Title
atezolizumab combined with doxorubicin
Arm Type
Experimental
Arm Description
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
Arm Title
doxorubicin monotherapy
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Atezolizumab
Intervention Description
atezolizumab
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
Doxorubicin
Primary Outcome Measure Information:
Title
Progression free survival
Description
after 9 months in the different arms by RECIST v1.1-criteria (doxorubicin, Atezolizumab and the combination of both)
Time Frame
after 9 months
Secondary Outcome Measure Information:
Title
Overall survival
Description
Overall survival in the different arms (doxorubicin, Atezolizumab and the combination of both)
Time Frame
after 24 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ignace Vergote, MD PhD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZLeuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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