Ovarian Cancer Clinical Trial

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

Summary

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

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

202

Study ID:

NCT03565991

Recruitment Status:

Active, not recruiting

Sponsor:

Pfizer

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There are 75 Locations for this study

See Locations Near You

Stanford Cancer Center
Palo Alto California, 94304, United States
Stanford Women's Cancer Center
Palo Alto California, 94304, United States
Stanford Healthcare
Stanford California, 94305, United States
Stanford University School of Medicine
Stanford California, 94305, United States
Atlanta Cancer Care -Alpharetta
Alpharetta Georgia, 30005, United States
Northside Hospital, Inc. - GCS/Athens
Athens Georgia, 30606, United States
Northside Hospital, Inc. - GCS/Annex
Atlanta Georgia, 30341, United States
Atlanta Cancer Care - Atlanta
Atlanta Georgia, 30342, United States
Northside Hospital, Inc. - Central Research Department
Atlanta Georgia, 30342, United States
Northside Hospital, Inc. - GCS/Northside
Atlanta Georgia, 30342, United States
Northside Hospital, Inc. - GCS/Canton
Canton Georgia, 30114, United States
Atlanta Cancer Care - Cumming
Cumming Georgia, 30041, United States
Atlanta Cancer Care - Decatur
Decatur Georgia, 30033, United States
Northside Hospital, Inc.-GCS/Stemmer
Decatur Georgia, 30033, United States
Atlanta Cancer Care - Stockbridge
Jonesboro Georgia, 30236, United States
Northside Hospital, Inc.-GCS/Macon
Macon Georgia, 31217, United States
Northside Hospital, Inc.-GCS/Kennestone
Marietta Georgia, 30060, United States
Ochsner Clinic Foundation
New Orleans Louisiana, 70121, United States
Brigham and Women's Hospital
Boston Massachusetts, 02115, United States
Dana Farber Cancer institute
Boston Massachusetts, 02215, United States
Siteman Cancer Center - West County
Creve Coeur Missouri, 63141, United States
Barnes-Jewish Hospital
Saint Louis Missouri, 63110, United States
Washington University Infusion Center Pharmacy
Saint Louis Missouri, 63110, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Siteman Cancer Center - South County
Saint Louis Missouri, 63129, United States
Siteman Cancer Center - North County
Saint Louis Missouri, 63136, United States
Siteman Cancer Center - St.Peters
Saint Peters Missouri, 63376, United States
Memorial Sloan Kettering Cancer Center- Monmouth
Middletown New Jersey, 07748, United States
Memorial Sloan Kettering Cancer Center- Westchester
Harrison New York, 10604, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York New York, 10016, United States
Laura and Isaac Perlmutter Cancer Center
New York New York, 10016, United States
NY Investigational Pharmacy
New York New York, 10016, United States
NYU Langone Medical Center
New York New York, 10016, United States
Rockefeller Outpatient Center
New York New York, 10022, United States
Memorial Hospital
New York New York, 10065, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
White Plains Hospital
White Plains New York, 10601, United States
The Ohio State University Wexner Medical Center
Columbus Ohio, 43210, United States
The Ohio State University
Columbus Ohio, 43210, United States
Martha Morehouse Medical Plaza
Columbus Ohio, 43221, United States
Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States
Hospital of the University of Pennsylvania/Penn Investigational Drug Services
Philadelphia Pennsylvania, 19104, United States
Hospital of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Magee-Women's Hospital Women's Cancer Center
Pittsburgh Pennsylvania, 15213, United States
UPMC Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States
Tennessee Oncology, PLLC
Chattanooga Tennessee, 37404, United States
The Sarah Cannon Research Institute
Chattanooga Tennessee, 37404, United States
Tennessee Oncology, PLLC
Cleveland Tennessee, 37311, United States
Tennessee Oncology, PLLC
Dickson Tennessee, 37055, United States
Tennessee Oncology, PLLC
Franklin Tennessee, 37067, United States
Tennessee Oncology, PLLC
Gallatin Tennessee, 37066, United States
Tennessee Oncology, PLLC
Hermitage Tennessee, 37076, United States
Tennessee Oncology, PLLC
Lebanon Tennessee, 37090, United States
Tennessee Oncology, PLLC
Murfreesboro Tennessee, 37129, United States
Tennessee Oncology, PLLC
Nashville Tennessee, 37203, United States
The Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Tennessee Oncology, PLLC
Nashville Tennessee, 37205, United States
Tennessee Oncology, PLLC
Nashville Tennessee, 37207, United States
Tennessee Oncology, PLLC
Nashville Tennessee, 37211, United States
Tennessee Oncology, PLLC
Shelbyville Tennessee, 37160, United States
Tennessee Oncology, PLLC
Smyrna Tennessee, 37167, United States
The University of Texas
Houston Texas, 77030, United States
Institut Jules Bordet
Brussels , 1000, Belgium
UZ Brussel
Brussel , 1090, Belgium
Universitair Ziekenhuis Antwerpen
Edegem , 2650, Belgium
Rigshospitalet
Copenhagen , 2100, Denmark
Odense University Hospital
Odense C , 5000, Denmark
Centre Jean Perrin
Clermont Ferrand , 63000, France
Groupe Hospitalier La Rochelle-Ré-Aunis
La Rochelle , 17000, France
Institut Regional du Cancer de Montpellier - ICM Val d'Aurelle
Montpellier Cedex 5 , 34298, France
Presidio AO-U, Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi
Torette Di Ancona AN, 60123, Italy
IRCCS-Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola FC, 47014, Italy
Azienda Socio-Sanitaria Territoriale Monza, Ospedale San Gerardo
Monza MB, 20900, Italy
Fondazione IRCCS, Istituto Nazionale dei Tumori
Milano MI, 20133, Italy
Istituto Europeo di Oncologia, Istituto di Ricovero e Cura a Carattere Scientifico
Milano MI, 20141, Italy
Fondazione Pascale, IRCCS, Istituto Nazionale dei Tumori
Napoli , 80131, Italy
Azienda Policlinico Umberto I, Universita La Sapienza, Oncologia B
Roma , 00161, Italy
Fondazione Policlinico Universitario Agostino Gemelli Unità di Farmacologia Clinica
Roma , 00168, Italy
National Cancer Center Hospital East
Kashiwa Chiba, 277-8, Japan
Osaka International Cancer Institute
Osaka-shi Osaka, 541-8, Japan
National Cancer Center Hospital
Chuo-ku Tokyo, 104-0, Japan
Amsterdam University Medical Centre, location VUmc
Amsterdam Noord Holland, 1081 , Netherlands
Erasmus Universitair Medisch Centrum
Rotterdam Zuid-holland, 3015 , Netherlands
Hospital Universitario Vall d'Hebron
Barcelona , 08035, Spain
H.G.U. Gregorio Maranon
Madrid , 28009, Spain
Clinica Universidad de Navarra
Madrid , 28027, Spain
H.U. Fundación Jiménez Díaz
Madrid , 28040, Spain
Hospital Universitario Virgen de Valme
Sevilla , 41014, Spain
Barts Health NHS Trust, St Bartholomew's Hospital
London , EC1A , United Kingdom
Sarah Cannon Research Institute UK
London , W1G 6, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

202

Study ID:

NCT03565991

Recruitment Status:

Active, not recruiting

Sponsor:


Pfizer

How clear is this clinincal trial information?

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