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Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer Treatment Study

Clinical Trial Title: 
Randomized, phase II/III study of pegylated liposomal doxorubicin & CTEP-supplied atezolizumab vs pegylated liposomal doxorubicin/bevacizumab & CTEP-supplied atezolizumab vs pegylated liposomal doxorubicin/bevacizumab in platinum resistant ovarian cancer.
Clinical Trial Protocol ID: 
18080203
Clinical Trial Investigator Name: 
Summer B. Dewdney, MD
Clinical Trial Protocol 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.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have the psychological ability and general health that permits completion of the study requirements and required follow up.
  • For women of child-bearing potential (WOCBP): Agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 5 months (150 days) after the last dose of study agent. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.
  • Submit of tumor tissue.
  • Have high grade ovarian cancer, including high grade serous; clear cell; endometrioid, grade 3; and others (adenocarcinoma, not otherwise specified [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.

You will be excluded from the study if any of the following criteria apply to you:

  • Have had prior allogeneic bone marrow transplantation or prior solid organ transplantation.
  • Have had systemic anticancer therapy (e.g., chemotherapy, targeted therapy) within 3 weeks prior to entering the study.
  • Have had hormonal therapy (e.g., tamoxifen, aromatase inhibitor) within 1 week prior to entering the study.
  • Have had prior treatment with anti-programmed cell death (PD)-1, anti- programmed cell death ligand (PD-L)1 or anti-cytotoxic T-lymphocyte-associated protein (CTLA)-4 therapeutic antibody or other similar agents.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Gynecologic Cancers
Contact Phone: 
(312) 942-2417
Contact Name: 
Lois Winkelman