Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:June 18, 2018
End Date:December 2, 2022
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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A PHASE 2 STUDY TO EVALUATE SAFETY AND ANTI-TUMOR ACTIVITY OF AVELUMAB IN COMBINATION WITH TALAZOPARIB IN PATIENTS WITH BRCA OR ATM MUTANT TUMORS

Avelumab in combination with talazoparib will be investigated in patients with locally
advanced or metastatic solid tumors with a BRCA or ATM defect.

Avelumab is a human immunoglobulin (Ig)G1 monoclonal antibody (mAb) directed against
programmed death ligand 1 (PD-L1). Avelumab selectively binds to PD-L1 and competitively
blocks its interaction with programmed death receptor 1 (PD-1), thereby interfering with this
key immune checkpoint inhibition pathway. Avelumab is currently being investigated as single
agent and in combination with other anti cancer therapies in patients with locally advanced
or metastatic solid tumors and various hematological malignancies.

Talazoparib is a potent, orally bioavailable poly (adenosine diphosphate [ADP] ribose)
polymerase (PARP) inhibitor, which is cytotoxic to human cancer cell lines harboring gene
mutations that compromise deoxyribonucleic acid (DNA) repair, an effect referred to as
synthetic lethality, and by trapping PARP protein on DNA thereby preventing DNA repair,
replication, and transcription.

Avelumab in combination with talazoparib will be investigated in patients with locally
advanced (primary or recurrent) or metastatic solid tumors with a BReast CAncer
susceptibility gene (BRCA)1, or BRCA2, or ataxia telangiectasia mutated (ATM) gene defect.

Inclusion Criteria:

- BRCA1, BRCA2 and/or ATM gene defect.

- Histological diagnosis of locally advanced (primary or recurrent) or metastatic solid
tumors that are not amenable for treatment with curative intent

- Availability a tumor tissue sample from a diagnostic biopsy/surgery or a metastatic
tumor biopsy.

- Progressive disease at study enrollment.

- Minimum age 18 years (in Japan, minimum age 20 years).

- ECOG performance status 0 or 1.

- Adequate bone marrow, renal and liver function.

- For childbearing female patients, negative serum or urine pregnancy test at screening

- Signed and dated informed consent document.

Exclusion Criteria:

- Prior anti-cancer therapy or radiation therapy within 2 weeks prior to enrolment.
Palliative radiotherapy to metastatic lesion(s) permitted providing that it has been
completed at least 2 days prior to enrolment and no significant toxicity are expected.

- Major surgery within 4 weeks prior to study enrollment.

- Current use of immunosuppressive medication at the time of study enrollment.

- Known prior severe hypersensitivity to investigational products or any component in
their formulations

- Known history of immune-mediated colitis, inflammatory bowel disease, pneumonitis,
pulmonary fibrosis.

- Active or prior autoimmune disease that might deteriorate when receiving an
immunostimulatory agent.

- Prior organ transplantation including allogenic stem-cell transplantation.

- Administration of live attenuated vaccines within 4 weeks of study enrollment.

- Diagnosis of myelodysplastic syndrome.

- Known symptomatic brain metastases requiring steroids.

- Persisting toxicity related to prior therapy Grade >1.

- Known history of HIV or AIDS.

- Positive HBV or HCV test indicating acute or chronic infection.

- Active infection requiring systemic therapy.

- Clinically significant (active) cardiovascular disease: cerebral vascular
accident/stroke or myocardial infarction within 6 months prior to study enrollment;
unstable angina, congestive heart failure or a serious cardiac arrhythmia requiring
medication.

- Diagnosis of any other malignancy within 2 years prior to study enrollment, except for
adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of
the breast, bladder, or cervix, or low-grade prostate cancer or other early-stage
low-risk cancers.

- Pregnant or breastfeeding female patients; female or male patients who are able to
have children who are unable or unwilling to use contraception as outlined in the
protocol.
We found this trial at
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500 Westchester Avenue
Harrison, New York 10604
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75 Francis street
Boston, Massachusetts 02115
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3400 Spruce St
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 (215) 662-4000
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291 Campus Dr
Stanford, California 94305
(650) 725-3900
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Alpharetta, Georgia 30005
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Atlanta, Georgia 30342
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Atlanta, Georgia 30341
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
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Chattanooga, Tennessee 37404
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Chattanooga, Tennessee 37404
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Cleveland, Tennessee 37311
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Columbus, Ohio 43221
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Creve Coeur, Missouri 63141
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Cumming, Georgia 30041
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Decatur, Georgia 30033
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Decatur, Georgia 30033
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Dickson, Tennessee 37055
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Franklin, Tennessee 37067
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Gallatin, Tennessee 37066
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Hermitage, Tennessee 37076
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Houston, Texas 77030
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Jonesboro, Georgia 30236
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Lebanon, Tennessee 37087
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Macon, Georgia 31217
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Marietta, Georgia 30060
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480 Red Hill Road
Middletown, New Jersey 07748
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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
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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New Orleans, Louisiana 70121
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New York, New York 10022
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1275 York Avenue
New York, New York 10065
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Oklahoma City, Oklahoma 73104
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Palo Alto, California 94304
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900 Blake Wilbur Drive
Palo Alto, California 94305
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Pittsburgh, Pennsylvania 15213
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Saint Louis, Missouri 63110
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660 S Euclid Ave
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(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Peters, Missouri 63376
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Shelbyville, Tennessee 37160
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Smyrna, Tennessee 37167
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Stanford, California 94305
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