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OpenTrials
Active, Not Recruiting

NCT Number: NCT03340376

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atezolizumab

Drug

atezolizumab

Doxorubicin

Drug

Doxorubicin

Primary outcomes

  1. 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)

Secondary outcomes

  1. Overall survival

    Time frame: after 24 months

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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Roche Pharma AG

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Nov 13, 2017
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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