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



Status:Recruiting
Conditions:Ovarian Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:July 19, 2018
End Date:May 18, 2026
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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A RANDOMIZED, OPEN-LABEL, MULTICENTER, PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AVELUMAB IN COMBINATION WITH CHEMOTHERAPY FOLLOWED BY MAINTENANCE THERAPY OF AVELUMAB IN COMBINATION WITH THE POLY (ADENOSINE DIPHOSPHATE [ADP]-RIBOSE) POLYMERASE (PARP) INHIBITOR TALAZOPARIB IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED OVARIAN CANCER (JAVELIN OVARIAN PARP100)

This is a Phase 3, randomized, open-label, multicenter study to evaluate the efficacy and
safety of avelumab in combination with chemotherapy followed by maintenance therapy of
avelumab in combination with the PARP inhibitor talazoparib in patients with previously
untreated advanced ovarian cancer. Eligible patients must have previously untreated
histologically confirmed Stage III IV epithelial ovarian, fallopian tube, or primary
peritoneal cancer and must be candidates for bevacizumab in combination with platinum based
chemotherapy.

This is a Phase 3, randomized, open-label, multicenter study to evaluate the efficacy and
safety of avelumab in combination with chemotherapy followed by maintenance therapy of
avelumab in combination with the PARP inhibitor talazoparib in patients with previously
untreated advanced ovarian cancer. Eligible patients must have previously untreated
histologically confirmed Stage III IV epithelial ovarian, fallopian tube, or primary
peritoneal cancer and must be candidates for bevacizumab in combination with platinum based
chemotherapy.

The primary purpose of the study is to demonstrate that avelumab in combination with
platinum-based chemotherapy followed by avelumab plus talazoparib maintenance is superior to
platinum-based chemotherapy plus bevacizumab followed by bevacizumab maintenance in
prolonging PFS in patients with advanced ovarian cancer.

Inclusion Criteria:

- 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
cytoreduction).

- Serum CA-125/CEA ratio >25. If the serum CA-125/CEA ratio is <25, then
workup should be negative for the presence of a primary gastrointestinal or
breast malignancy (<6 weeks before start of neoadjuvant treatment).

- 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:

- 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-α), 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.
We found this trial at
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Dickson, Tennessee 37055
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Baltimore, Maryland 21231
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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3550 Jerome Avenue
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1024 1st Street North
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Arlington Heights, Illinois 60005
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550 Peachtree St NE
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1364 Clifton Rd NE
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40 Chasely Street
Auchenflower, Queensland 4066
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Bedford, Texas 76022
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Danbury, Connecticut 06810
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Fayetteville, Arkansas 72703
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Murfreesboro, Tennessee 37130
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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3322 West End Avenue
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5900 Lake Wright Dr
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Scottsdale, Arizona 85258
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Shelbyville, Tennessee 37160
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7695 South Research Drive
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Tualatin, Oregon 97062
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721 Clinic Drive
Tyler, Texas 75701
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Vancouver, Washington 98684
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