Study ID: NRG GY009
A randomized, phase II/III study of pegylated liposomal doxorubicin and CTEP-supplied atezolizumab vs. pegylated liposomal doxorubicin/bevacizumab and CTEP-supplied atezolizumab vs. pegylated liposomal doxorubicin/bevacizumab in platinum-resistant ovarian cancer
This clinical trial is for patients who have been diagnosed with high-grade ovarian cancer, defined for this study as cancer of the ovary or ovaries, fallopian tube(s) or peritoneum, which is the serous membrane that lines the abdomen and covers the abdominal organs. Participants must have already undergone platinum-based chemotherapy, but their cancer has returned.
Researchers seek to determine how well pegylated liposomal doxorubicin (PLD) hydrochloride, a drug used in chemotherapy, works with monoclonal antibodies such as atezolizumab (Tecentriq®) and/or bevacizumab (Avastan®). It is thought that monoclonal antibodies may interfere with the ability of tumor cells to grow and spread. It is not yet known which combination of drugs will work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.
Participants are randomized into three treatment arms:
- Arm 1: PLD and atezolizumab
- Arm 2: PLD, bevacizumab and atezolizumab
- Arm 3: PLD and bevacizumab
- 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 is defined here as ovarian, fallopian tube or primary peritoneal cancer
- Recurrent, platinum-resistant ovarian cancer
- 1–2 prior regimens (including primary therapy); hormonal therapies (e.g., tamoxifen, aromatase inhibitors) will not count toward the prior regimen limit
Note: Additional inclusion criteria apply. Please contact the clinical trials coordinator for more information.
- Arm 1: Patients receive PLD IV over 60 minutes on day 1, and atezolizumab IV over 30–60 minutes on days 1 and 15
- Arm 2: Patients receive PLD IV over 60 minutes on day 1, bevacizumab IV over 30–90 minutes on days 1 and 15, and atezolizumab IV over 30–60 minutes on days 1 and 15
- Arm 3: Patients receive PLD IV over 60 minutes on day 1, and bevacizumab IV over 30–90 minutes on days 1 and 15
- Must have been diagnosed with high-grade ovarian cancer, fallopian tube cancer or peritoneal cancer
- Must have already undergone platinum-based chemotherapy and developed a resistance to the treatment