Home
Clinical Trials
Javelin BRCA/ATM: Avelumab Pl...

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

Last Updated: 2023-09-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-18

Study Completion Date

2023-02-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

NCT04550494

Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage IV Breast Cancer AJCC v8 Castration-Resistant Prostate Carcinoma +28 more

RECRUITING PHASE2

Avelumab in Third-Line Gastric Cancer (JAVELIN Gastric 300)

NCT02625623

Unresectable, Recurrent, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Gastric Cancer Third Line

COMPLETED PHASE3

Talazoparib in Treating Patients With Recurrent, Refractory, Advanced, or Metastatic Cancers and Alterations in the BRCA Genes

NCT02286687

Advanced Malignant Neoplasm ATM Gene Mutation BRCA1 Gene Mutation +5 more

ACTIVE_NOT_RECRUITING PHASE2

Avelumab and Trabectedin in Treating Patients With Liposarcoma or Leiomyosarcoma That is Metastatic or Cannot Be Removed by Surgery

NCT03074318

Metastatic Leiomyosarcoma Metastatic Liposarcoma Unresectable Leiomyosarcoma +1 more

TERMINATED PHASE1/PHASE2

Talazoparib and Avelumab in Participants With Metastatic Renal Cell Carcinoma

NCT04068831

Metastatic Renal Cell Carcinoma Fumarate Hydratase Deficient Renal Cell Carcinoma Succinate Dehydrogenase Deficient Renal Cell Carcinoma

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Locally Advanced or Metastatic Solid Tumors Genes, BRCA 1

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open label

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Combination of avelumab and talazoparib

Single arm open label

Group Type EXPERIMENTAL

Avelumab

Intervention Type DRUG

IV treatment

Talazoparib

Intervention Type DRUG

Oral treatment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Avelumab

IV treatment

Intervention Type DRUG

Talazoparib

Oral treatment

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Bavencio MDV3800, BMN 673

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Stanford Cancer Center

Palo Alto, California, United States

Site Status

Stanford Women's Cancer Center

Palo Alto, California, United States

Site Status

Stanford Healthcare

Stanford, California, United States

Site Status

Stanford University School of Medicine

Stanford, California, United States

Site Status

Atlanta Cancer Care -Alpharetta

Alpharetta, Georgia, United States

Site Status

Northside Hospital, Inc. - GCS/Athens

Athens, Georgia, United States

Site Status

Northside Hospital, Inc. - GCS/Annex

Atlanta, Georgia, United States

Site Status

Atlanta Cancer Care - Atlanta

Atlanta, Georgia, United States

Site Status

Northside Hospital, Inc. - Central Research Department

Atlanta, Georgia, United States

Site Status

Northside Hospital, Inc. - GCS/Northside

Atlanta, Georgia, United States

Site Status

Northside Hospital, Inc. - GCS/Canton

Canton, Georgia, United States

Site Status

Atlanta Cancer Care - Cumming

Cumming, Georgia, United States

Site Status

Atlanta Cancer Care - Decatur

Decatur, Georgia, United States

Site Status

Northside Hospital, Inc.-GCS/Stemmer

Decatur, Georgia, United States

Site Status

Atlanta Cancer Care - Stockbridge

Jonesboro, Georgia, United States

Site Status

Northside Hospital, Inc.-GCS/Macon

Macon, Georgia, United States

Site Status

Northside Hospital, Inc.-GCS/Kennestone

Marietta, Georgia, United States

Site Status

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Dana Farber Cancer institute

Boston, Massachusetts, United States

Site Status

Siteman Cancer Center - St.Peters

City of Saint Peters, Missouri, United States

Site Status

Siteman Cancer Center - West County

Creve Coeur, Missouri, United States

Site Status

Barnes-Jewish Hospital

St Louis, Missouri, United States

Site Status

Washington University Infusion Center Pharmacy

St Louis, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Siteman Cancer Center - South County

St Louis, Missouri, United States

Site Status

Siteman Cancer Center - North County

St Louis, Missouri, United States

Site Status

Memorial Sloan Kettering Cancer Center- Monmouth

Middletown, New Jersey, United States

Site Status

Memorial Sloan Kettering Cancer Center- Westchester

Harrison, New York, United States

Site Status