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

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03340376
Collaborator
Roche Pharma AG (Industry)
48
Enrollment
1
Location
3
Arms
60.1
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

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

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Study Design

Study Type:
Interventional
Actual 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 :
Aug 30, 2017
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. Progression free survival [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 [after 24 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1UZLeuvenLeuvenBelgium3000

Sponsors and Collaborators

  • Universitaire Ziekenhuizen Leuven
  • Roche Pharma AG

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT03340376
Other Study ID Numbers:
  • BGOG-cx3
First Posted:
Nov 13, 2017
Last Update Posted:
Jan 27, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 27, 2021