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

July 2, 2024 updated by: Universitaire Ziekenhuizen KU Leuven

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZLeuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
after 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: after 24 months
Overall survival in the different arms (doxorubicin, Atezolizumab and the combination of both)
after 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

Roche Pharma AG

Investigators

  • Principal Investigator: Ignace Vergote, MD PhD, Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2017

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

April 5, 2017

First Submitted That Met QC Criteria

November 8, 2017

First Posted (Actual)

November 13, 2017

Study Record Updates

Last Update Posted (Actual)

July 3, 2024

Last Update Submitted That Met QC Criteria

July 2, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BGOG-cx3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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