Spots Global Cancer Trial Database for Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors
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Trial Identification
Brief Title: Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors
Official Title: 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 JAVELIN BRCA/ATM
Study ID: NCT03565991
Study Description
Brief Summary: Avelumab in combination with talazoparib will be investigated in patients with locally advanced or metastatic solid tumors with a BRCA or ATM defect.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Stanford Cancer Center, Palo Alto, California, United States
Stanford Women's Cancer Center, Palo Alto, California, United States
Stanford Healthcare, Stanford, California, United States
Stanford University School of Medicine, Stanford, California, United States
Atlanta Cancer Care -Alpharetta, Alpharetta, Georgia, United States
Northside Hospital, Inc. - GCS/Athens, Athens, Georgia, United States
Northside Hospital, Inc. - GCS/Annex, Atlanta, Georgia, United States
Atlanta Cancer Care - Atlanta, Atlanta, Georgia, United States
Northside Hospital, Inc. - Central Research Department, Atlanta, Georgia, United States
Northside Hospital, Inc. - GCS/Northside, Atlanta, Georgia, United States
Northside Hospital, Inc. - GCS/Canton, Canton, Georgia, United States
Atlanta Cancer Care - Cumming, Cumming, Georgia, United States
Atlanta Cancer Care - Decatur, Decatur, Georgia, United States
Northside Hospital, Inc.-GCS/Stemmer, Decatur, Georgia, United States
Atlanta Cancer Care - Stockbridge, Jonesboro, Georgia, United States
Northside Hospital, Inc.-GCS/Macon, Macon, Georgia, United States
Northside Hospital, Inc.-GCS/Kennestone, Marietta, Georgia, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
Dana Farber Cancer institute, Boston, Massachusetts, United States
Siteman Cancer Center - West County, Creve Coeur, Missouri, United States
Barnes-Jewish Hospital, Saint Louis, Missouri, United States
Washington University Infusion Center Pharmacy, Saint Louis, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Siteman Cancer Center - South County, Saint Louis, Missouri, United States
Siteman Cancer Center - North County, Saint Louis, Missouri, United States
Siteman Cancer Center - St.Peters, Saint Peters, Missouri, United States
Memorial Sloan Kettering Cancer Center- Monmouth, Middletown, New Jersey, United States
Memorial Sloan Kettering Cancer Center- Westchester, Harrison, New York, United States
Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy, Long Island City, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, United States
Laura and Isaac Perlmutter Cancer Center, New York, New York, United States
NY Investigational Pharmacy, New York, New York, United States
NYU Langone Medical Center, New York, New York, United States
NYU Langone Radiology - 32nd Street, New York, New York, United States
NYU Langone Radiology Ambulatory Care Center East 41st Street, New York, New York, United States
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street)., New York, New York, United States
Rockefeller Outpatient Center, New York, New York, United States
Rockefeller Outpatient Pavilion (53rd Street), New York, New York, United States
Evelyn H. Lauder Breast and Imaging Center, New York, New York, United States
Memorial Hospital, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
White Plains Hospital, White Plains, New York, United States
The Ohio State University Wexner Medical Center, Columbus, Ohio, United States
The Ohio State University, Columbus, Ohio, United States
Stephanie Spielman Comprehensive Breast Cancer, Columbus, Ohio, United States
Martha Morehouse Medical Plaza, Columbus, Ohio, United States
OSU Gynecologic Oncology at Mill Run, Hilliard, Ohio, United States
Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Hospital of the University of Pennsylvania/Penn Investigational Drug Services, Philadelphia, Pennsylvania, United States
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Penn IDS Central, Philadelphia, Pennsylvania, United States
Magee-Women's Hospital Women's Cancer Center, Pittsburgh, Pennsylvania, United States
UPMC Hillman Cancer Center Investigational Drug Service, Pittsburgh, Pennsylvania, United States
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Tennessee Oncology, PLLC, Chattanooga, Tennessee, United States
The Sarah Cannon Research Institute, Chattanooga, Tennessee, United States
Tennessee Oncology, PLLC, Cleveland, Tennessee, United States
Tennessee Oncology, PLLC, Dickson, Tennessee, United States
Tennessee Oncology, PLLC, Franklin, Tennessee, United States
Tennessee Oncology, PLLC, Gallatin, Tennessee, United States
Tennessee Oncology, PLLC, Hermitage, Tennessee, United States
Tennessee Oncology, PLLC, Lebanon, Tennessee, United States
Tennessee Oncology, PLLC, Murfreesboro, Tennessee, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
The Sarah Cannon Research Institute, Nashville, Tennessee, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
Tennessee Oncology, PLLC, Shelbyville, Tennessee, United States
Tennessee Oncology, PLLC, Smyrna, Tennessee, United States
The University of Texas, Houston, Texas, United States
Institut Jules Bordet, Brussels, , Belgium
UZ Brussel, Brussel, , Belgium
Universitair Ziekenhuis Antwerpen, Edegem, , Belgium
Rigshospitalet, Copenhagen, , Denmark
Odense University Hospital, Odense C, , Denmark
Centre Jean Perrin, Clermont Ferrand, , France
Groupe Hospitalier La Rochelle-Ré-Aunis, La Rochelle, , France
Institut Regional du Cancer de Montpellier - ICM Val d'Aurelle, Montpellier Cedex 5, , France
Presidio AO-U, Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi, Torette Di Ancona, AN, Italy
IRCCS-Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), Meldola, FC, Italy
Azienda Socio-Sanitaria Territoriale Monza, Ospedale San Gerardo, Monza, MB, Italy
Fondazione IRCCS, Istituto Nazionale dei Tumori, Milano, MI, Italy
Istituto Europeo di Oncologia, Istituto di Ricovero e Cura a Carattere Scientifico, Milano, MI, Italy
Fondazione Pascale, IRCCS, Istituto Nazionale dei Tumori, Napoli, , Italy
Azienda Policlinico Umberto I, Universita La Sapienza, Oncologia B, Roma, , Italy
Fondazione Policlinico Universitario Agostino Gemelli Unità di Farmacologia Clinica, Roma, , Italy
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
Osaka International Cancer Institute, Osaka-shi, Osaka, Japan
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
Amsterdam University Medical Centre, location VUmc, Amsterdam, Noord Holland, Netherlands
Erasmus Universitair Medisch Centrum, Rotterdam, Zuid-holland, Netherlands
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
H.G.U. Gregorio Maranon, Madrid, , Spain
Clinica Universidad de Navarra, Madrid, , Spain
H.U. Fundación Jiménez Díaz, Madrid, , Spain
Hospital Universitario Virgen de Valme, Sevilla, , Spain
Barts Health NHS Trust, St Bartholomew's Hospital, London, , United Kingdom
Sarah Cannon Research Institute UK, London, , United Kingdom
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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