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Phase II/III Study of Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer.
Overall Recruitment Status: Active, currently enrolling
 
Official Title
NRG-GY009 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
 
Region Sponsors
Mid-Atlantic
National Cancer Institute (NCI), NRG / NRG Oncology
 
Acronym KP IRB No.
NRG-GY009 1341275
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
The trial is open to females only, Age = 18. High grade ovarian cancer, including high grade serous; clear cell; endometrioid, grade 3; and others (adenocarcinoma, NOS; mixed epithelial carcinoma; undifferentiated carcinoma), Recurrent, platinum resistant ovarian cancer (defined as progression within < 6 months from completion of platinum based therapy. The date should be calculated from the last administered dose of platinum therapy), Measurable disease (defined by RECIST v 1.1) or evaluable disease (defined as solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions OR ascites and/or pleural effusion that has been pathologically demonstrated to be disease related in the setting of CA125 = 2xULN) and Performance Status 0, 1 or 2.
 
Purpose
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.
 
Detailed 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. This trial will also estimate and compare dose limiting toxicity (DLT) following cycle 1 of experimental regimens (pegylated liposomal doxorubicin hydrochloride [pegylated liposomal doxorubicin] [PLD] and atezolizumab and PLD/bevacizumab and atezolizumab). (Safety lead-in) II, the hazard of first progression or death (progression free survival [PFS]) of each experimental regimen relative to the reference regimen, PLD and bevacizumab. (Phase II study) III and the hazard of death and the hazard of first progression or death (PFS) of each experimental regimen relative to the reference regimen.
 
Gender Age Limit
Female
 
Inclusion Criteria
  • Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up
  • Women of child-bearing potential (WOCBP) must 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
  • Submission of tumor tissue is required for all patients, investigators should check with their site pathology department regarding release of biospecimens before approaching patients about participation in the trial
  • High grade ovarian cancer, including high grade serous, clear cell, endometrioid, grade 3, and others (adenocarcinoma, nitric oxide synthase [NOS], mixed epithelial carcinoma, undifferentiated carcinoma)
  • Measurable disease (defined by RECIST v. 1.1) or evaluable disease (defined as solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions OR ascites and/or pleural effusion that has been pathologically demonstrated to be disease related in the setting of cancer antigen [CA]25 >= 2 x upper limit of normal [ULN])
 
Exclusion Criteria
  • 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-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
  • 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
  • Patients who have not recovered from adverse events to < grade 1 (other than alopecia) due to agents administered more than 3 weeks earlier, however, the following therapies are allowed: 1. Hormone replacement therapy or oral contraceptives 2. Herbal therapy > 1 week prior to cycle 1, day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to cycle 1, day 1) 3.Palliative radiotherapy for bone metastases > 2 weeks prior to cycle 1, day 1
  • Treatment with any other investigational agent within 4 weeks prior to cycle 1, day 1
  • Treatment with systemic immunostimulatory agents (including, but not limited to, interferon [IFN]-alpha or interleukin [IL]-2) within 6 weeks prior to cycle 1, day

 
Keywords and/or Specific Medical Conditions
  • Obstetrics and Gynecology
  • Pathology
  • Oncology (Adult)
 
KP Clinical Facility
  • Burke Medical Center
  • Capitol Hill Medical Center
  • Gaithersburg Medical Center
  • Largo Medical Center
  • Springfield Medical Center
  • Tyson's Corner Medical Center
  • Woodlawn Medical Center
 
Clinical Area
  • Obstetrics and Gynecology
  • Oncology (Adult)
  • Pathology


Principal Investigator:
Leon Hwang, MD
Contact Information:
- Leslie Greenberg, MS, RN
-301-816-6426
-Leslie.K.Greenberg@kp.org
-Gaithersburg Medical Center


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