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Avelumab and Talazoparib in Untreated Advanced Ovarian Cancer (JAVELIN OVARIAN PARP 100)

Last updated on September 12, 2019

Study Location
Danbury Hospital
Danbury, Connecticut, 06810 United States
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Ovarian Cancer
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 carcinosarcoma with high-grade serous component.

- Patients must be candidates for bevacizumab in combination with platinum based
chemotherapy and previously untreated.

- Must have completed a primary surgical debulking procedure, or be candidates for
neoadjuvant chemotherapy with planned interval debulking surgery.

1. Patients who completed primary debulking must have had incompletely resected
disease that is macroscopically/grossly visible and at least with lesions >1 mm
and be randomized at a maximum of 8 weeks after surgery.

2. For patients who are candidates for neoadjuvant chemotherapy, the diagnoses must
have been confirmed by:

- Core tissue (not fine-needle aspiration) biopsy is required for diagnosis.

- Stage IIIC-IV documented via imaging or surgery (without attempt at

- Serum CA-125/CEA ratio >25. If the serum CA-125/CEA ratio is workup should be negative for the presence of a primary gastrointestinal or
breast malignancy (

- Randomization must occur within 8 weeks after diagnosis.

- Availability of an archival FFPE tumor tissue block or a minimum of 25 slides,
together with an accompanying original H&E slide. If archived FFPE tissue is not
available, a de novo (ie, fresh) tumor sample must be obtained in accordance with
local institutional practice for tumor biopsies. Tumor tissue must contain 40% or
greater tumor nuclei per central laboratory assessment.

- ECOG performance status 0-1

- Age >=18 years (or >=20 years in Japan).

- Adequate bone marrow, hepatic, and renal function and blood coagulation

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Non-epithelial tumors or ovarian tumors with low malignant potential (ie, borderline
tumors) or mucinous tumors.

- Patients for whom intraperitoneal cytotoxic chemotherapy is planned.

- Prior exposure to immunotherapy with interleukin (IL)-2, interferon alpha (IFN-?), or
an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte
associated antigen 4 (anti-CTLA4) antibody (including ipilimumab), or any other
antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint
pathways, excluding therapeutic anticancer vaccines.

- Prior treatment with a PARP inhibitor.

- Prior treatment with any anti-vascular endothelial growth factor (VEGF) drug,
including bevacizumab.

- Major surgery (other than debulking or exploratory surgery for ovarian cancer) for any
reason within 4 weeks prior to randomization and/or incomplete recovery from surgery.

- Prior radiotherapy to any portion of the abdominal cavity or pelvis. Prior radiation
for localized cancer of the breast, head and neck, or skin is permitted, provided that
it was completed more than three years prior to registration, and the patient remains
free of recurrent or metastatic disease.

- Prior targeted therapy (including but not limited to vaccines, antibodies, tyrosine
kinase inhibitors) or hormonal therapy for management of their ovarian, peritoneal
primary or fallopian tube carcinoma.

- Prior organ transplantation including allogenic stem cell transplantation.

- Diagnosis of Myelodysplastic Syndrome (MDS).

- 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
enrollment, have discontinued corticosteroid treatment for these metastases for at
least 4 weeks and are neurologically stable.

Active, not recruiting
Avelumab and Talazoparib in Untreated Advanced Ovarian Cancer (JAVELIN OVARIAN PARP 100)


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