NRG-GY009

Clinical Trial Title A Randomized, Phase II/III Study of Pegylated Lipsomal Doxorubicin and CTEP-Supplied Atezolizumab versus Pegylated Liposomal Doxorubicin/Bevacizumab and CTEP-Supplied Atezolizumab versus Pegylated Liposomal Doxorubicin/Bevacizumab in Platinum Resistant Ovarian Cancer
Trial Status Closed to Enrollment
Start Date 12/11/2018
Location Doctors & Locations
Trial Type Cancer - Adult Oncology
Specific Condition Ovarian Cancer
Description This randomized phase II/III trial studies how well pegylated liposomal doxorubicin hydrochloride with atezolizumab and/or bevacizumab work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back. Drugs used in chemotherapy, such as pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as atezolizumab and bevacizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known which combination will work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.
Eligibility Criteria

Eligibility Criteria

  • High grade ovarian cancer, including high grade serous; clear cell; endometrioid, grade 3; and others (adenocarcinoma, NOS; mixed epithelial carcinoma; undifferentiated carcinoma).
  • Recurrent, platinum resistant ovarian cancer (defined as progression within < 6 months from completion of platinum based therapy.
  • 1-2 prior regimens (including primary therapy). Hormonal therapies (e.g., tamoxifen, aromatase inhibitors) will not count toward the prior regimen limit.
  • Performance Status 0, 1 or 2

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

 

 
IRB Number Central IRB
Notes https://clinicaltrials.gov/ct2/show/NCT02839707?term=nrg-gy009
Principal Investigator Colleen McCormick, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail oncologyresearch@lhs.org