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

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ClinicalTrials.gov Identifier: NCT03565991

Recruitment Status : Terminated (The study was terminated since there was no need for further safety or efficacy data to be collected. The participants having benefit from the investigational treatments have been moved to a continuation study (NCT05059522))

First Posted : June 21, 2018

Results First Posted : August 7, 2023

Last Update Posted : September 25, 2023

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Sponsor:

Information provided by (Responsible Party):

Pfizer

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.

Condition or disease	Intervention/treatment	Phase
Locally Advanced or Metastatic Solid Tumors Genes, BRCA 1	Drug: Avelumab Drug: Talazoparib	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	202 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Intervention Model Description:	Single arm study with two cohorts enrolled in parallel. Cohort 1 will enroll patients with locally advanced or metastatic solid tumors with one or more defects in the BRCA1 or BRCA2 genes Cohort 2 will enroll patients with locally advanced or metastatic solid tumors with one or more defects in the ATM gene
Masking:	None (Open Label)
Masking Description:	Open label
Primary Purpose:	Treatment
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
Actual Study Start Date :	June 18, 2018
Actual Primary Completion Date :	March 28, 2022
Actual Study Completion Date :	February 3, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Talazoparib Avelumab

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Combination of avelumab and talazoparib Single arm open label	Drug: Avelumab IV treatment Other Name: Bavencio Drug: Talazoparib Oral treatment Other Name: MDV3800, BMN 673

Outcome Measures

Primary Outcome Measures :

Percentage of Participants With Confirmed Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR) [ Time Frame: From the first dose of study treatment until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to approximately 24 months ]
For participants with solid tumors, except metastatic Castration Resistant Prostate Cancer (mCRPC), OR was defined as a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1), both confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. For participants with mCRPC, OR was defined as the percentage of participants with a best overall soft tissue response of CR or PR per RECIST v1.1 with no evidence of confirmed bone disease progression per Prostate Cancer Working Group 3 (PCWG3) criteria. Per RECIST v1.1, CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. Non-target PR lesions must be non-Progressive Disease (PD), where PD was unequivocal progression of pre-existing lesions.

Secondary Outcome Measures :

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: From baseline up to 30 days after last dose of study treatment, maximum up to 4.3 years approximately ]
An adverse event (AE) was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device. TEAEs were those events with onset dates occurring during the on-treatment period. A Serious Adverse Event (SAE) was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or resulted in congenital anomaly/birth defect. A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. TEAEs were graded by the investigator using National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) v4.03 as Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE.
Number of Participants With New or Worsening Hematology Laboratory Test Results During the On-Treatment Period [ Time Frame: From baseline up to 30 days after last dose of study treatment, maximum up to 4.3 years approximately ]
The laboratory results were graded according to the CTCAE v4.03 severity grade whenever applicable. Laboratory test abnormalities were summarized according to worst toxicity grade observed for each laboratory test. As per NCI CTCAE toxicity grading v4.03, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE. On-treatment period was defined as the time from the first dose of study treatment through minimum (30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day).
Number of Participants With New or Worsening Chemistry Laboratory Test Results During the On-Treatment Period [ Time Frame: From baseline up to 30 days after last dose of study treatment, maximum up to 4.3 years approximately ]
The laboratory results were graded according to the CTCAE v4.03 severity grade whenever applicable. Laboratory test abnormalities were summarized according to worst toxicity grade observed for each laboratory test. As per NCI CTCAE toxicity grading v4.03, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE. On-treatment period was defined as the time from the first dose of study treatment through minimum (30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day).
Serum Lowest (Trough) Concentration (Ctrough) of Avelumab [ Time Frame: Predose on Day 1 of Cycles 1, 3, 6, 12, 18, 24 and Day 15 of Cycle 1 ]
Ctrough was defined as predose concentration during multiple dosing. The determination method of Ctrough was observing directly from data. The lower limit of quantification (LLQ) was 0.2 mcg/mL. For Cycle 1 Day 1, as the number of observations above lower limit of quantification (NALQ) = 0, summary statistics were not presented.
Serum Maximum Concentration (Cmax) for Avelumab [ Time Frame: One hour post-dose on Day 1 of Cycles 1, 3, 6, 12, 18, 24 and Day 15 of Cycle 1 ]
Cmax was defined as maximum observed plasma concentration. The determination method of Cmax was observing directly from data.
Plasma Ctrough for Talazoparib [ Time Frame: Predose on Cycle 1 Days 1, 15 and Cycle 3 Day 1 ]
Ctrough was defined as predose concentration during multiple dosing. The determination method of Ctrough was observing directly from data. The lower limit of quantification (LLQ) was 25 pg/mL. For Cycle 1 Day 1, as the number of observations above lower limit of quantification (NALQ) = 0, summary statistics were not presented. Evaluable participants were participants with non-missing Ctrough concentrations at each specific time point and meeting 2 conditions: participants received 14 consecutive days of talazoparib dose without dosing interruption prior to sample collection (except on Cycle 1 Day 1) and sample collection within 24 hours ± 10% (2 hours and 24 minutes) after the previous day's dose and no more than 5 minutes (0.083 hours) after the administration of the dose on the day of PK sample collection. Predose PK samples on Cycle 1 Day 1 must have been collected prior to dose.
Plasma Post-dose Concentrations for Talazoparib [ Time Frame: Postdose (samples collected within 2 hours post dose plus/minus 12 minutes) on Days 1,15 of Cycle 1, and Day 1 of Cycle 3 ]
In this OM, the post-dose concentrations for talazoparib in plasma were reported.
Number of Participants by Avelumab Anti-drug Antibody (ADA) Categories [ Time Frame: Predose (within 2 hours before start of avelumab infusion) on Day 1 of Cycles 1, 3, 6, 12, 18, 24 and Day 15 of Cycle 1 ]
Blood samples were assayed for ADA using a validated assay. ADA never-positive = no positive ADA results at any time point. ADA ever-positive =at least one positive ADA result at any time point. Baseline ADA positive =a positive ADA result at baseline. Treatment-boosted ADA =a positive ADA result at baseline and the titer >=8×baseline titer at least once after treatment with avelumab. Treatment-induced ADA = participant was ADA-negative at baseline and had at least one positive post-baseline ADA result; or the participant had at least one positive post-baseline ADA result if no baseline sample. Transient ADA response = participants with treatment-induced ADA had (a single positive ADA result or duration between first and last positive result <16 weeks) and ADA result at the last assessment was not positive. Persistent ADA response =participants with treatment-induced ADA had duration between first and last positive ADA result >=16 weeks or a positive ADA result at the last assessment.
Number of Participants With Neutralizing Antibodies (Nab) Levels Against Avelumab Ever-Positive [ Time Frame: Predose (within 2 hours before start of avelumab infusion) on Day 1 of Cycles 1, 3, 6, 12, 18, 24 and Day 15 of Cycle 1 ]
Nab ever-positive was defined as at least one positive Nab result at any time point. Samples positive for ADA with persistent treatment-induced ADA response could be analyzed for Nab.
Percentage of Participants With Confirmed OR as Assessed by The Investigator [ Time Frame: From the first dose of study treatment until the date of first documented disease progression or date of death from any cause, whichever comes first, assessed up to approximately 24 months ]
For participants with solid tumors, except mCRPC, OR was defined as a CR or PR per RECIST v1.1, both confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. For participants with mCRPC, OR was defined as the percentage of participants with a best overall soft tissue response of CR or PR per RECIST v1.1 with no evidence of confirmed bone disease progression per PCWG3 criteria. Per RECIST v1.1, CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. Non-target PR lesions must be non-PD, where PD was unequivocal progression of pre-existing lesions.
Time to Tumor Response (TTR) as Assessed by BICR [ Time Frame: Baseline up to approximately 24 months ]
For participants with solid tumors, except mCRPC: TTR was defined for participants with confirmed objective response (CR or PR) as the time from the first dose of study treatment to the first documentation of objective tumor response. For participants with mCRPC: TTR was defined as the time from the first dose of study treatment to the first objective evidence of soft tissue response with no evidence of confirmed bone disease progression on bone scan per PCWG3. Soft tissue response was defined as a Best Overall Response (BOR) of CR or PR per RECIST v1.1.
TTR as Assessed by Investigator [ Time Frame: Baseline up to approximately 24 months ]
For participants with solid tumors, except mCRPC: TTR was defined for participants with confirmed objective response (CR or PR) as the time from the first dose of study treatment to the first documentation of objective tumor response. For participants with mCRPC: TTR was defined as the time from the first dose of study treatment to the first objective evidence of soft tissue response with no evidence of confirmed bone disease progression on bone scan per PCWG3. Soft tissue response was defined as a BOR of CR or PR per RECIST v1.1.
Duration of Response (DoR) as Assessed by BICR [ Time Frame: Baseline up to approximately 24 months ]
For participants with solid tumors, except mCRPC: DoR was defined for participants with confirmed objective response (CR or PR) as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occured first. For participants with mCRPC: DoR was defined for participants with confirmed objective response (CR or PR) as the time from the first objective evidence of soft tissue response (subsequently confirmed) per RECIST v1.1 and no evidence of confirmed bone disease progression by PCWG3 to the first subsequent objective evidence of radiographic progression or death due to any cause, whichever occured first. Radiographic progression was defined as soft tissue progression evaluated per RECIST v1.1 or bone disease progression evaluated per PCWG3.
DoR as Assessed by Investigator [ Time Frame: Baseline up to approximately 24 months ]
For participants with solid tumors, except mCRPC: DoR was defined for participants with confirmed objective response (CR or PR) as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. For participants with mCRPC: DoR was defined for participants with confirmed objective response (CR or PR) as the time from the first objective evidence of soft tissue response (subsequently confirmed) per RECIST v1.1 and no evidence of confirmed bone disease progression by PCWG3 to the first subsequent objective evidence of radiographic progression or death due to any cause, whichever occurred first. Radiographic progression was defined as soft tissue progression evaluated per RECIST v1.1 or bone disease progression evaluated per PCWG3.
Progression Free Survival (PFS) as Assessed by BICR [ Time Frame: Baseline up to approximately 24 months ]
For participants with solid tumors, except mCRPC: PFS was defined as the time from the first dose of study treatment to the date of disease progression by RECIST v1.1 or death due to any cause, whichever occurred first. For participants with mCRPC: PFS was defined as the time from the first dose of study treatment to documentation of radiographic progression in soft tissue evaluated per RECIST v1.1, in bone evaluated per PCWG3, or death, whichever occurred first.
PFS as Assessed by Investigator [ Time Frame: Baseline up to approximately 24 months ]
For participants with solid tumors, except mCRPC: PFS was defined as the time from the first dose of study treatment to the date of disease progression by RECIST v1.1 or death due to any cause, whichever occurred first. For participants with mCRPC: PFS was defined as the time from the first dose of study treatment to documentation of radiographic progression in soft tissue evaluated per RECIST v1.1, in bone evaluated per PCWG3, or death, whichever occurred first.
Overall Survival (OS) for All Participants [ Time Frame: Baseline up to approximately 24 months ]
OS was defined as the time from the first dose of study treatment to the date of death. Participants without an event (death) were censored at the date of last contact.
Time to Prostate-Specific Antigen (PSA) Progression for Participants With mCRPC [ Time Frame: Baseline up to approximately 24 months ]
For participants with mCRPC, time to PSA progression was defined as the time from the first dose to the date that a >=25% increase in PSA with an absolute increase of >=2 μg/L (2 ng/mL) above the nadir (or baseline for participants with no PSA decline) was documented, confirmed by a second consecutive PSA value obtained >=3 weeks (21 days) later.
Number of Participants With Confirmed PSA Response [ Time Frame: Baseline up to approximately 24 months ]
For participants with mCRPC, PSA response was defined as confirmed PSA decline >=50% compared to baseline. PSA response was calculated as a decline from baseline PSA (ng/mL) to the maximal PSA response with a threshold of 50%. A PSA response must have been confirmed by a second consecutive value at least 3 weeks later.
Number of Participants With Circulating Tumor Cell (CTC) Count Conversion [ Time Frame: Day 1 of Cycle 1 to Cycle 4 ]
For participants with mCRPC, CTC count conversion was defined as a decrease in CTC count from >=5 CTC per 7.5 mL of blood at baseline to <5 CTC per 7.5 mL of blood anytime on study.
Number of Participants With Cancer Antigen 125 (CA-125) Response [ Time Frame: Baseline, Day 1 of each treatment Cycle, maximum up to 4.3 years approximately ]
For participants with ovarian cancer, CA-125 response was defined as at least a 50% reduction in CA-125 levels from baseline. The response must have been confirmed and maintained for at least 28 days.
Number of Participants With Positive Programmed Death Ligand 1 (PD-L1) Expression in Baseline Tumor Tissue [ Time Frame: Baseline ]
PD-L1 expression on tumor and infiltrating immune cells was measured by immunohistochemistry (IHC). PD-L1 expression level was defined as the number of PD-L1 positive cells and/or qualitative assessment of PD-L1 staining on tumor and inflammatory cells in regions of interest. This OM reported the number of participants classified as positive according to scoring algorithms and cut-offs established from external sources.
Number of Participants With Different Status for Defects in BRCA1, BRCA2 and ATM [ Time Frame: Baseline ]
Participants were enrolled in the two cohorts based on BRCA 1/2 and ATM defect status assessed by the local laboratory. The participant BRCA and ATM status was assessed retrospectively by central laboratory, that may differ from the status assessed by the local laboratory. The ATM participants with a negative ATM status per the central laboratory were reported to have a positive ATM status per the local laboratory. Therefore, participants with negative ATM status might have been included in the ATM defect cohort. For defects in BRCA1, BRCA2 and ATM by central laboratory analysis, participants were classified as positive, negative, not analyzable or missing. The number of participants in each category of BRCA 1 defect, BRCA 2 defect, BRCA 1 or BRCA 2 defect and ATM defect were presented.
Number of Participants by Status of Tumor Mutational Burden (TMB) at Baseline [ Time Frame: Baseline ]
TMB was defined as the total number of mutations in the tumor genome, or number of mutations per megabase of DNA if derived from targeted sequencing. TMB categories were defined as high, low for a number of mutations per megabase >=10 and <10, respectively. The TMB category 'Not analyzable' included participants with available samples but not evaluable. The TMB category 'Missing' included participants with no sample available. The number of participants in each category at only baseline were tabulated.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03565991

Locations

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United States, California
Stanford Cancer Center
Palo Alto, California, United States, 94304
Stanford Women's Cancer Center
Palo Alto, California, United States, 94304
Stanford Healthcare
Stanford, California, United States, 94305
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Georgia
Atlanta Cancer Care -Alpharetta
Alpharetta, Georgia, United States, 30005
Northside Hospital, Inc. - GCS/Athens
Athens, Georgia, United States, 30606
Northside Hospital, Inc. - GCS/Annex
Atlanta, Georgia, United States, 30341
Atlanta Cancer Care - Atlanta
Atlanta, Georgia, United States, 30342
Northside Hospital, Inc. - Central Research Department
Atlanta, Georgia, United States, 30342
Northside Hospital, Inc. - GCS/Northside
Atlanta, Georgia, United States, 30342
Northside Hospital, Inc. - GCS/Canton
Canton, Georgia, United States, 30114
Atlanta Cancer Care - Cumming
Cumming, Georgia, United States, 30041
Atlanta Cancer Care - Decatur
Decatur, Georgia, United States, 30033
Northside Hospital, Inc.-GCS/Stemmer
Decatur, Georgia, United States, 30033
Atlanta Cancer Care - Stockbridge
Jonesboro, Georgia, United States, 30236
Northside Hospital, Inc.-GCS/Macon
Macon, Georgia, United States, 31217
Northside Hospital, Inc.-GCS/Kennestone
Marietta, Georgia, United States, 30060
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana Farber Cancer institute
Boston, Massachusetts, United States, 02215
United States, Missouri
Siteman Cancer Center - West County
Creve Coeur, Missouri, United States, 63141
Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
Washington University Infusion Center Pharmacy
Saint Louis, Missouri, United States, 63110
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Siteman Cancer Center - South County
Saint Louis, Missouri, United States, 63129
Siteman Cancer Center - North County
Saint Louis, Missouri, United States, 63136
Siteman Cancer Center - St.Peters
Saint Peters, Missouri, United States, 63376
United States, New Jersey
Memorial Sloan Kettering Cancer Center- Monmouth
Middletown, New Jersey, United States, 07748
United States, New York
Memorial Sloan Kettering Cancer Center- Westchester
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy
Long Island City, New York, United States, 11101
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
Laura and Isaac Perlmutter Cancer Center
New York, New York, United States, 10016
NY Investigational Pharmacy
New York, New York, United States, 10016
NYU Langone Medical Center
New York, New York, United States, 10016
NYU Langone Radiology - 32nd Street
New York, New York, United States, 10016
NYU Langone Radiology Ambulatory Care Center East 41st Street
New York, New York, United States, 10017
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
New York, New York, United States, 10021
Rockefeller Outpatient Center
New York, New York, United States, 10022
Rockefeller Outpatient Pavilion (53rd Street)
New York, New York, United States, 10022
Evelyn H. Lauder Breast and Imaging Center
New York, New York, United States, 10065
Memorial Hospital
New York, New York, United States, 10065
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
White Plains Hospital
White Plains, New York, United States, 10601
United States, Ohio
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
The Ohio State University
Columbus, Ohio, United States, 43210
Stephanie Spielman Comprehensive Breast Cancer
Columbus, Ohio, United States, 43212
Martha Morehouse Medical Plaza
Columbus, Ohio, United States, 43221
OSU Gynecologic Oncology at Mill Run
Hilliard, Ohio, United States, 43026
United States, Oklahoma
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Hospital of the University of Pennsylvania/Penn Investigational Drug Services
Philadelphia, Pennsylvania, United States, 19104
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Penn IDS Central
Philadelphia, Pennsylvania, United States, 19104
Magee-Women's Hospital Women's Cancer Center
Pittsburgh, Pennsylvania, United States, 15213
UPMC Hillman Cancer Center Investigational Drug Service
Pittsburgh, Pennsylvania, United States, 15232
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Tennessee Oncology, PLLC
Chattanooga, Tennessee, United States, 37404
The Sarah Cannon Research Institute
Chattanooga, Tennessee, United States, 37404
Tennessee Oncology, PLLC
Cleveland, Tennessee, United States, 37311
Tennessee Oncology, PLLC
Dickson, Tennessee, United States, 37055
Tennessee Oncology, PLLC
Franklin, Tennessee, United States, 37067
Tennessee Oncology, PLLC
Gallatin, Tennessee, United States, 37066
Tennessee Oncology, PLLC
Hermitage, Tennessee, United States, 37076
Tennessee Oncology, PLLC
Lebanon, Tennessee, United States, 37090
Tennessee Oncology, PLLC
Murfreesboro, Tennessee, United States, 37129
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37203
The Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37205
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37207
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37211
Tennessee Oncology, PLLC
Shelbyville, Tennessee, United States, 37160
Tennessee Oncology, PLLC
Smyrna, Tennessee, United States, 37167
United States, Texas
The University of Texas
Houston, Texas, United States, 77030
Belgium
Institut Jules Bordet
Brussels, Belgium, 1000
UZ Brussel
Brussel, Belgium, 1090
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, 2650
Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Odense University Hospital
Odense C, Denmark, 5000
France
Centre Jean Perrin
Clermont Ferrand, France, 63000
Groupe Hospitalier La Rochelle-Ré-Aunis
La Rochelle, France, 17000
Institut Regional du Cancer de Montpellier - ICM Val d'Aurelle
Montpellier Cedex 5, France, 34298
Italy
Presidio AO-U, Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi
Torette Di Ancona, AN, Italy, 60123
IRCCS-Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola, FC, Italy, 47014
Azienda Socio-Sanitaria Territoriale Monza, Ospedale San Gerardo
Monza, MB, Italy, 20900
Fondazione IRCCS, Istituto Nazionale dei Tumori
Milano, MI, Italy, 20133
Istituto Europeo di Oncologia, Istituto di Ricovero e Cura a Carattere Scientifico
Milano, MI, Italy, 20141
Fondazione Pascale, IRCCS, Istituto Nazionale dei Tumori
Napoli, Italy, 80131
Azienda Policlinico Umberto I, Universita La Sapienza, Oncologia B
Roma, Italy, 00161
Fondazione Policlinico Universitario Agostino Gemelli Unità di Farmacologia Clinica
Roma, Italy, 00168
Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
Osaka International Cancer Institute
Osaka-shi, Osaka, Japan, 541-8567
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
Netherlands
Amsterdam University Medical Centre, location VUmc
Amsterdam, Noord Holland, Netherlands, 1081 HV
Erasmus Universitair Medisch Centrum
Rotterdam, Zuid-holland, Netherlands, 3015 GD
Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 08035
H.G.U. Gregorio Maranon
Madrid, Spain, 28009
Clinica Universidad de Navarra
Madrid, Spain, 28027
H.U. Fundación Jiménez Díaz
Madrid, Spain, 28040
Hospital Universitario Virgen de Valme
Sevilla, Spain, 41014
United Kingdom
Barts Health NHS Trust, St Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
Sarah Cannon Research Institute UK
London, United Kingdom, W1G 6AD

Sponsors and Collaborators

Pfizer

Investigators

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Study Director:	Pfizer CT.gov Call Center	Pfizer

Study Documents (Full-Text)

Documents provided by Pfizer:

Study Protocol [PDF] November 15, 2018

Statistical Analysis Plan [PDF] December 16, 2021

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Schram AM, Colombo N, Arrowsmith E, Narayan V, Yonemori K, Scambia G, Zelnak A, Bauer TM, Jin N, Ulahannan SV, Colleoni M, Aftimos P, Donoghue MTA, Rosen E, Rudneva VA, Telli ML, Domchek SM, Galsky MD, Hoyle M, Chappey C, Stewart R, Blake-Haskins JA, Yap TA. Avelumab Plus Talazoparib in Patients With BRCA1/2- or ATM-Altered Advanced Solid Tumors: Results From JAVELIN BRCA/ATM, an Open-Label, Multicenter, Phase 2b, Tumor-Agnostic Trial. JAMA Oncol. 2023 Jan 1;9(1):29-39. doi: 10.1001/jamaoncol.2022.5218. Erratum In: JAMA Oncol. 2023 Jul 1;9(7):1009.

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Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT03565991
Other Study ID Numbers:	B9991032 2018-000345-39 ( EudraCT Number )
First Posted:	June 21, 2018 Key Record Dates
Results First Posted:	August 7, 2023
Last Update Posted:	September 25, 2023
Last Verified:	August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL:	https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Pfizer:


BRCA, ATM

Additional relevant MeSH terms:

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Avelumab Talazoparib Antineoplastic Agents, Immunological Antineoplastic Agents	Poly(ADP-ribose) Polymerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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