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Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100)

Last updated on March 15, 2019

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Study Location
Alabama Oncology
Alabaster, Alabama, 35007 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 Stage III-IV epithelial ovarian, fallopian tube, or primary
peritoneal cancer, including malignant mixed Müllerian tumors with high grade serous
component

- Patients must be candidates for platinum based chemotherapy and previously untreated

- Patients must have completed a surgical debulking procedure, or be candidates for
neoadjuvant chemotherapy

- Availability of an archival formalin fixed, paraffin embedded (FFPE) tumor tissue
block or a minimum of 15 slides

- ECOG PS 0-1

- Adequate hematological, renal, and liver function

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

- Non epithelial tumors or ovarian tumors with low malignant potential (ie, borderline
tumors) or mucinous tumors

- Prior systemic anti-cancer treatment for EOC, FTC, or PPC including prior
immunotherapy with IL 2, IFN ?, or anti PD 1, anti PD L1, anti PD L2, anti CD137, or
anti cytotoxic T lymphocyte associated antigen 4 (anti CTLA 4) antibody (including
ipilimumab), or any other antibody or drug specifically targeting T cell co
stimulation or immune checkpoint pathways

- Patients for whom, in the opinion of the Investigator, there is clinical benefit to
administer bevacizumab as a first-line treatment and for whom bevacizumab is approved
and available in this setting.

- Cancer for which intraperitoneal cytotoxic chemotherapy is planned

- Active autoimmune disease (some exceptions include diabetes type I, vitiligo,
psoriasis, hypo- or hyperthyroidism not requiring immunosuppressive treatment)

NCT02718417
Pfizer
Active, not recruiting
Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100)

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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