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A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer (JAVELIN Ovarian 200)

Last updated on June 13, 2019

FOR MORE INFORMATION
Study Location
Arizona Oncology Associates, PC - HAL
Chandler, Arizona, 85224 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ovarian Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Histologically confirmed epithelial ovarian, fallopian tube, or peritoneal cancer.

- Platinum resistant/refractory disease, defined as disease progression within 180 days
following the last administered dose of platinum therapy (resistant), or lack of
response or disease progression while receiving the most recent platinum based
therapy (refractory), respectively.

- Received up to 3 lines of chemotherapy for platinum sensitive disease, most recently
platinum containing, and no prior therapy for platinum resistant disease.

- Measurable disease by investigator assessment with at least 1 unidimensional
measurable lesion by RECIST v.1.1 that has not previously been irradiated.

- Active autoimmune disease that might deteriorate when receiving an immunostimulatory
agents. Patients with diabetes type I, vitiligo, psoriasis, hypo or hyperthyroid
disease not requiring immunosuppressive treatment are eligible.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Non epithelial tumor, including malignant mixed Müllerian tumors without high grade
serous component, or ovarian tumors with low malignant potential (ie, borderline
tumors).

- Prior therapy with an anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti
cytotoxic T lymphocyte associated antigen 4 (CTLA 4) antibody (including ipilimumab,
tremelimumab or any other antibody or drug specifically targeting T cell co
stimulation or immune checkpoint pathways).

- Known symptomatic brain metastases requiring steroids. Patients with previously
diagnosed brain metastases are eligible if they have completed their treatment and
have recovered from the acute effects of radiation therapy or surgery prior to study
entry, have discontinued corticosteroid treatment for these metastases for at least 4
weeks prior to study entry and are neurologically stable.

- Diagnosis of any other malignancy within 5 years prior to registration, except for
adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of
the breast or of the cervix.

- Severe gastrointestinal conditions such as clinical or radiological evidence of bowel
obstruction within 4 weeks prior to study entry, uncontrolled diarrhea in the last 4
weeks prior to enrollment, or history of inflammatory bowel disease.

NCT02580058
Pfizer
Active, not recruiting
A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer (JAVELIN Ovarian 200)

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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