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Research & Clinical Trials > Study Search Tool > A Phase II Study to Evaluate the Safety and Anti-tumor Activity of Avelumab in Combination with Talazoparib in Patients with a BRCA or ATM Mutation

A Phase II Study to Evaluate the Safety and Anti-tumor Activity of Avelumab in Combination with Talazoparib in Patients with a BRCA or ATM Mutation

This study is open to:

Men and women with metastatic advanced solid tumor cancer who:

  • have a documented BRCA1, BRCA2 and/or ATM gene mutation in the tumor
  • have cancer that is not responsive to standard therapies
  • have available tumor tissue sample from a biopsy/surgery or a metastatic tumor biopsy
  • Participants must wait at least 2 weeks after last treatment or radiation before enrolling
This study is not open to:

Potential participants will be excluded who have:

  • received treatment within 2 weeks of enrollment
  • are receiving immunosuppressive medication at the time of study enrollment
  • significant heart or vascular disease
  • spread of cancer to their brain
  • were diagnosed with any other cancer within 2 years prior to study enrollment, except for: 
    • basal cell or squamous cell skin cancer
    • carcinoma in situ of the breast, bladder, or cervix
    • low-grade prostate cancer or other early-stage low-risk cancers
A Phase II Study to Evaluate the Safety and Anti-tumor Activity of Avelumab in Combination with Talazoparib in Patients with a BRCA or ATM Mutation

Immunotherapy and PARP Inhibitor Combo for Advanced Cancers Caused By a BRCA or ATM Mutation

Clinicaltrials.gov identifier:
NCT03565991

Treatment:
Breast
Ovarian
Pancreatic

Study Contact Information

To learn more about the study, call or email Pfizer Clinical Trial Contact Center, by phone:1-800-718-1021 or by email.

 

About the Study

This study is looking at how well two cancer drugs work together to treat certain advanced cancers. 

The researchers want to learn how safe and effective the combination of an immunotherapy (known as Avelumab) and a PARP inhibitor (known as Talazoparib) is for treating patients with locally advanced or metastatic solid tumors with a BRCA1, BRCA2, or ATM gene defect.

Type of Study

This is a single-arm, open-label study. This means that all patients in the study will receive the same treatments.

What the Study Entails

  • Study participants will all receive both treatments:
    • the immunotherapy agent Avelumab will be given as an intravenous (IV) treatment.
    • participants will take the PARP inhibitor Talazoparib orally.
  • Participants will continue treatment and receive evaluations for up to 24 months, or until they are no longer benefitting from the treatment (disease progression), they experience serious side effects or they decide they no longer wish to participate. 

Study Sites

  • California
    • Palo Alto, CA:  Stanford Cancer Center
    • Stanford, CA:  Stanford University School of Medicine    
  • Georgia
    • Alpharetta, GA:  Atlanta Cancer Care -Alpharetta
    • Athens, GA: Northside Hospital, Inc. - GCS/Athens
    • Atlanta, GA: Atlanta Cancer Care - Atlanta       
    • Atlanta, GA: Northside Hospital, Inc. - Central Research Department
    • Cumming, GA: Atlanta Cancer Care - Cumming  
    • Decatur, GA: Atlanta Cancer Care - Decatur     
    • Jonesboro, GA: Atlanta Cancer Care - Stockbridge
    • Macon, GA: Northside Hospital, Inc.-GCS/Macon
    • Marietta, GA: Northside Hospital, Inc.-GCS/Kennestone
  • Louisiana
    • New Orleans: Ochsner Clinic Foundation
  • Massachusetts
    • Boston, MA: Brigham and Women's Hospital
    • Boston, MA:  Dana Farber Cancer institute
  • Missouri
    • Creve Coeur, MO: Siteman Cancer Center - West County
    • St. Louis, MO: Barnes-Jewish Hospital    
    • Saint Louis, MO: Washington University School of Medicine
    • Saint Louis, MO: Siteman Cancer Center - South County   
    • St. Peters, MO:  Siteman Cancer Center - St.Peters 
  • New Jersey
    • Monmouth, NJ: Memorial Sloan Kettering Cancer Center- Monmouth
  • New York
    • Harrison, NY: Memorial Sloan Kettering Cancer Center- Westchester
    • New York, NY: Laura and Isaac Perlmutter Cancer Center at NYU Langone
    • New York, NY: Memorial Sloan Kettering Cancer Center
    • White Plains, NY: White Plains Hospital
  • Ohio
    • Columbus, OH: The Ohio State University Wexner Medical Center
    • Columbus, OH: Martha Morehouse Medical Plaza
  • Oklahoma
    • Oklahoma City, OK: Stephenson Cancer Center
  • Pennsylvania
    • Philadelphia, PA: Hospital of the University of Pennsylvania
    • Pittsburgh, PA: Magee-Women`s Hospital Women`s Cancer Center 
    • Pittsburgh, PA: UPMC Hillman Cancer Center Investigational Drug Service     
  • Tennessee
    • Chattanooga, TN: Tennessee Oncology 
    • Chattanooga, TN: The Sarah Cannon Research Institute
    • Cleveland, TN: Tennessee Oncology
    • Dickson, TN: Tennessee Oncology
    • Franklin, TN: Tennesse Oncology
    • Gallatin, TN: Tennessee Oncology
    • Hermitage, TN: Tennessee Oncology
    • Lebanon, TN: Tennessee Oncology
    • Murfreesboro, TN: Tennessee Oncology
    • Nashville, TN: The Sarah Cannon Research Institute 
    • Nashville, TN: Tennessee Oncology
    • Shelbyville, TN: Tennessee Oncology
    • Smyrna, TN: Tennessee Oncology
  • Texas
    • Houston, TX: The University of Texas           

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