This 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 (recurrent). Chemotherapy drugs, such as
pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the growth of
tumor 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.
I. Estimate the probability of a 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. Estimate and compare 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. Estimate and compare the hazard of death and the hazard of first
progression or death (PFS) of each experimental regimen relative to the reference regimen.
I. Estimate and compare the probabilities of response rate (objective response rate [ORR],
either partial or complete response) defined by Response Evaluation Criteria in Solid Tumors
(RECIST) version (v)1.1 criteria on each study regimen. (Phase II study) II. Estimate the
frequency and severity of adverse events as classified and graded with Common Terminology
Criteria for Adverse Events (CTCAE) in those patients who initiate their randomly assigned
study treatment. (Phase II study) III. Estimate and compare ORR in each treatment group.
(Phase III study) IV. Estimate the frequency and severity of adverse events in those patients
who initiate their randomly assigned study treatment. (Phase III study) V. Estimate and
compare mean patient reported outcome scores (PROs) as measured by National Comprehensive
Cancer Network (NCCN)-Functional Assessment of Cancer Therapy (FACT) ovarian symptom index
(NFOSI)-18 disease-related symptoms (DRS). (Phase III study) VI. Estimate and compare the
treatment groups on the basis of the PROs: treatment side effects (TSE), function/well-being
(FWB), fatigue (Functional Assessment of Chronic Illness Therapy [FACIT]-fatigue subscale)
and abdominal discomfort (FACT/Gynecologic Oncology Group [GOG]-abdominal discomfort [AD]
subscale). (Phase III study)
TRANSLATIONAL SCIENCE OBJECTIVES:
I. To determine whether biomarker levels in pre-treatment tissue, and pre- or on-treatment
peripheral blood, and stool specimens are associated with ORR, PFS and/or overall survival
II. To determine whether changes in quantitative biomarker parameters after the first 6 and
12 weeks of therapy predict ORR, PFS and/or OS.
OUTLINE: Patients will be randomized to 1 of 3 arms.
ARM I: Patients receive pegylated liposomal doxorubicin hydrochloride intravenously (IV) over
60 minutes on day 1 and atezolizumab IV over 30-60 minutes on days 1 and 15.
ARM II: Patients receive pegylated liposomal doxorubicin hydrochloride 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 III: Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on
day 1 and bevacizumab IV over 30-90 minutes on days 1 and 15.
In all arms, cycles repeat every 28 days in the absence of disease progression or
After completion of study treatment, patients are followed up every 3 months for up to 2
years, and then every 6 months for up to 3 years.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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