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Gynecologic
General Information
Study Name:
NRG GY 009: A 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
Age Group:
Adult
Protocol Number:
NCT02839707
Background Information:
This study is for patients who have ovarian cancer, fallopian tube cancer or primary peritoneal cancer which has grown or has recurred. 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. 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). The addition of Atezolizumab to the usual chemotherapy or the usual chemotherapy with bevacizumab could shrink the cancer but it could also cause side effects. This study will allow the researchers to know whether the different approaches are better, the same, or worse than the usual approach.
Offered at:
Inova Schar Cancer Institute
3289 Woodburn Road Suite 245
Annandale, VA 22003
Eligibility Information
High grade ovarian cancer, including high grade serous; clear cell; endometrioid, grade 3; and others (adenocarcinoma, NOS; mixed epithelial carcinoma; undifferentiated carcinoma). NOTE: Low grade serous, mucinous and carcinosarcoma histologies are excluded due to their different underlying genomic features and/or clinical behavior. Ovarian cancer = ovarian, fallopian tube or primary peritoneal cancer. Required data element: submission of pathology report.
Recurrent, platinum resistant ovarian cancer (defined as progression within < 6 months from completion of platinum based therapy.
Additional eligibility in protocol.
Ineligibility Information
Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation.
Patients who have had systemic anticancer therapy (e.g., chemotherapy, targeted therapy) within 3 weeks prior to entering the study.
Patients who have had hormonal therapy (e.g., tamoxifen, aromatase inhibitor) within 1 week prior to entering the study.
Patients with prior treatment with anti-PD-1, anti-PD-L1 or anti-CTLA-4 therapeutic antibody or other similar agents.
Patients with prior treatment with bevacizumab (or any other anti vascular therapy, e.g., cediranib) for platinum resistant recurrence. (Note: Prior bevacizumab in initial therapy and/or platinum sensitive recurrent setting is allowed.)
Patients with prior treatment with PLD.
Prior radiotherapy to the abdomen or pelvis
Additional ineligibility in protocol.
Contact Information
Contact Name:
Catherine D’Reaux, RN, BSN, OCN
Contact Phone:
703-208-6630
Contact Email:
catherine.dreaux@inova.org