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NRG GY009

Trial Overview

Official Title

A Randomized, Phase II/III Study Of Pegylated Liposomal Doxorubicin And Ctep-Supplied Atezolizumab (Ind #134427) Versus Pegylated Liposomal Doxorubicin/Bevacizumab And Ctep-Supplied Atezolizumab Versus Pegylated Liposomal Doxorubicin/Bevacizumab In Platinum Resistant Ovarian Cancer

Study Purpose

To compare any good and bad effects of adding Atezolizumab to the usual chemotherapy, (liposomal doxorubicin) and to the usual chemotherapy with bevacizumab.

Diagnosis

High grade ovarian cancer, including high grade serous; clear cell; endometroid, grade 3, and others (adenocarcinoma, NOS, mixed epithelial carcinoma; undifferentiated carcinoma).

Eligibility

Must have had at least one prior platinum based therapy

Must have cancer recurrence or progression within < 6 months from completion of platinum based therapy. The date will be calculated from the last administered dose.

Measurable or evaluable disease

Adequate kidney, liver and thyroid function

Negative pregnancy test if of child bearing potential

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Intervention

  • Study agents:Peglyated liposomal Doxorubicin,  Atezolizumab, Bevacizumab
  • Quality of Life questionnaires
  • ARM A: Liposomal doxorubicin and Atezolizumab.  (Study Group)
  • ARM B: Liposomal doxorubicin and Atezolizumab and Bevacizumab (Study Group) 
  • ARM C: Liposomal doxorubicin and Bevacizumab (Usual approach)
  • Follow ups occur every 3 months for 2 years and then every 6 months for 3 years.   

For more information, visit ClinicalTrials.gov

Key Participation Requirements
Gender
Female
Age
19 years and older
Phase
Phase III
Methodist Health System Trial Code
GY009