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
ClinicalTrials.gov