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NRG GY009

Status:

Recruiting | Phase III

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:

The purpose of this study is to compare any good and bad effects of adding Atezolizumab to the usual chemotherapy, (liposomal doxorubicin) and to the usual chemotherapy with bevacizumab.

Interventions:

  • 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)

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.   

Key Participation Requirements:

Gender:

Female

Age:

19 years and older

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.

Methodist Health System Trial Code:

NRG GY009

For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today!