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

UnknownPhase 2

Sponsor: Universitaire Ziekenhuizen KU Leuven

Conditions: Cervical Cancer

Interventions: Atezolizumab, Doxorubicin

Countries: Belgium

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

Eligibility overview

Sex: FEMALE

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (1)

Leuven, Belgium