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

Use our guide to learn which trials are right for you!

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
67
sites
?
mi
from
Newark, NJ
Click here to add this to my saved trials
Baltimore, Maryland 21231
410-955-6190
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
?
mi
from
Bronx, NY
Click here to add this to my saved trials
1024 1st Street North
Alabaster, Alabama 35007
?
mi
from
Alabaster, AL
Click here to add this to my saved trials
Arlington Heights, Illinois 60005
?
mi
from
Arlington Heights, IL
Click here to add this to my saved trials
550 Peachtree St NE
Atlanta, Georgia 30308
(404) 686-4411
Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Atlanta, Georgia 30322
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Atlanta, Georgia 30322
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Atlanta, Georgia 30322
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
40 Chasely Street
Auchenflower, Queensland 4066
?
mi
from
Auchenflower,
Click here to add this to my saved trials
Baltimore, Maryland 21287
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Bedford, Texas 76022
?
mi
from
Bedford, TX
Click here to add this to my saved trials
Bessemer, Alabama 35022
?
mi
from
Bessemer, AL
Click here to add this to my saved trials
Birmingham, Alabama 35223
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Bronx, New York 10461
?
mi
from
Bronx, NY
Click here to add this to my saved trials
?
mi
from
Bronx, NY
Click here to add this to my saved trials
?
mi
from
Bronx, NY
Click here to add this to my saved trials
5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Danbury, Connecticut 06810
?
mi
from
Danbury, CT
Click here to add this to my saved trials
Dickson, Tennessee 37055
?
mi
from
Dickson, TN
Click here to add this to my saved trials
Fayetteville, Arkansas 72703
?
mi
from
Fayetteville, AR
Click here to add this to my saved trials
Fort Worth, Texas 76104
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Franklin, Tennessee 37067
?
mi
from
Franklin, TN
Click here to add this to my saved trials
Gallatin, Tennessee 37066
?
mi
from
Gallatin, TN
Click here to add this to my saved trials
Hermitage, Tennessee 37076
?
mi
from
Hermitage, TN
Click here to add this to my saved trials
Irvine, California 92614
?
mi
from
Irvine, CA
Click here to add this to my saved trials
?
mi
from
Irving, TX
Click here to add this to my saved trials
?
mi
from
Irving, TX
Click here to add this to my saved trials
Lebanon, Tennessee 37087
?
mi
from
Lebanon, TN
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
259 1st Street
Mineola, New York 11501
?
mi
from
Mineola, NY
Click here to add this to my saved trials
?
mi
from
Mineola, NY
Click here to add this to my saved trials
Mineola, New York 11501
?
mi
from
Mineola, NY
Click here to add this to my saved trials
?
mi
from
Mineola, NY
Click here to add this to my saved trials
Mineola, New York 11501
?
mi
from
Mineola, NY
Click here to add this to my saved trials
Murfreesboro, Tennessee 37130
?
mi
from
Murfreesboro, TN
Click here to add this to my saved trials
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,...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New Haven, Connecticut 06520
?
mi
from
New Haven, CT
Click here to add this to my saved trials
?
mi
from
Newark, NJ
Click here to add this to my saved trials
?
mi
from
Newark, NJ
Click here to add this to my saved trials
?
mi
from
Newark, NJ
Click here to add this to my saved trials
Newport Beach, California 92663
?
mi
from
Newport Beach, CA
Click here to add this to my saved trials
5900 Lake Wright Dr
Norfolk, Virginia 23502
(757) 466-8683
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Norwalk, Connecticut 06856
?
mi
from
Norwalk, CT
Click here to add this to my saved trials
Phoenix, Arizona 85016
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Portland, Oregon 97213
?
mi
from
Portland, OR
Click here to add this to my saved trials
Rogers, Arkansas 72758
?
mi
from
Rogers, AR
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
San Francisco, California 94114
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
San Francisco, California 94115
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
3700 California Street
San Francisco, California 94118
(415) 600-6000
California Pacific Medical Center - California Campus California Pacific Medical Center is one of the...
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
3700 California Street
San Francisco, California 94118
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Santa Barbara, California 93105
?
mi
from
Santa Barbara, CA
Click here to add this to my saved trials
Scottsdale, Arizona 85258
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
Shelbyville, Tennessee 37160
?
mi
from
Shelbyville, TN
Click here to add this to my saved trials
Smyrna, Tennessee 37167
?
mi
from
Smyrna, TN
Click here to add this to my saved trials
7695 South Research Drive
Tempe, Arizona 85284
?
mi
from
Tempe, AZ
Click here to add this to my saved trials
Tualatin, Oregon 97062
?
mi
from
Tualatin, OR
Click here to add this to my saved trials
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
721 Clinic Drive
Tyler, Texas 75701
?
mi
from
Tyler, TX
Click here to add this to my saved trials
Vancouver, Washington 98684
?
mi
from
Vancouver, WA
Click here to add this to my saved trials