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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03340376

Enrollment

Registered

2017-11-13

Start date

2017-08-30

Completion date

2025-09-30

Last updated

2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

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

Interventions

DRUGAtezolizumab

atezolizumab

DRUGDoxorubicin

Doxorubicin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 100 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026