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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03340376
• Other study ID #: BGOG-cx3
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 30, 2017
• Est. completion date: September 2022

Study information

• Verified date: January 2021
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: September 2022
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• Atezolizumab
atezolizumab
• Doxorubicin
Doxorubicin

Locations

Country	Name	City	State
Belgium	UZLeuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Roche Pharma AG

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	after 9 months in the different arms by RECIST v1.1-criteria (doxorubicin, Atezolizumab and the combination of both)	after 9 months
Secondary	Overall survival	Overall survival in the different arms (doxorubicin, Atezolizumab and the combination of both)	after 24 months