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Randomized, Phase II/III Study of Pegylated Liposomal Doxorubicin and CTEP-Supplied Atezolizumab versus Pegylated Liposomal Doxorubicin/Bevacizumab and CTEP-Supplied Atezolizumab versus Pegylated Liposomal Doxorubicin/Bevacizumab in Platinum Resistant Ovarian Cancer

Protocol No
NRG-GY009
Principal Investigator
William Bradley
Phase
II/III
Summary
This study is being carried out under the sponsorship of NRG Oncology, an organization dedicated to clinical research in the field of gynecologic cancer. NRG Oncology is funded by the Federal Government through the National Cancer Institute (NCI). There will be 10 subjects enrolled at this site. You are being asked to participate in the safety lead-in portion of this study. The purpose of the first part of the safety lead-in portion is to test the safety of adding atezolizumab to liposomal doxorubicin to find out what effects, if any, it has on people. Atezolizumab is a PD-L1 inhibitor that may allow the immune system to recognize and destroy tumor cells. It is an experimental medication (not approved by the FDA). There will be about 8 people taking part in this portion of the study. The safety of liposomal doxorubicin and atezolizumab will be evaluated by looking at the side effects the first 8 patients have. If the combination of atezolizumab and liposomal doxorubicin is safe in the first group of patients, then the second part of the safety lead-in will further test the safety of the addition of atezolizumab to liposomal doxorubicin and bevacizumab. The safety of liposomal doxorubicin, bevacizumab and atezolizumab will be evaluated by looking at the side effects the first 8 patients have. If the treatment is safe in this group of patients, then the study will also compare the side effects of three treatments. There will be about 24 people taking part in this portion of the study, 8 people in each group. If the treatments are safe for the group of 24 patients, the same treatments will be offered to additional patients in the Phase II and III portions of the study, which will be done to find out whether the different approaches are better, the same or worse than the usual approach. The information obtained from the patients in the safety lead-in will also be used by researchers to find this out. Another purpose of this study is for researchers to learn if a biomarker test is helpful to decide whether or not a patient s tumor has certain characteristics and will respond to study drug. Tissue from your surgery will be used for the biomarker test. Researchers do not know if using the biomarker test is better, the same, or worse than if you enrolled in this study without using the biomarker test.
Description
Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL
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