RecruitingPhase 2NCT03971409

Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer

Innovative Combination Immunotherapy for Metastatic Triple Negative Breast Cancer (TNBC): A Multicenter, Multi-Arm Translational Breast Cancer Research Consortium Study


Sponsor

Laura Huppert, MD, BA

Enrollment

150 participants

Start Date

Jul 8, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial studies how well the combination of avelumab with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan works in treating patients with triple negative breast cancer that is stage IV or is not able to be removed by surgery (unresectable) and has come back (recurrent). Immunotherapy with checkpoint inhibitors like avelumab require activation of the patient's immune system. This trial includes a two week induction or lead-in of medications that can stimulate the immune system. It is our hope that this induction will improve the response to immunotherapy with avelumab. One treatment, sacituzumab Govitecan, is a monoclonal antibody called sacituzumab linked to a chemotherapy drug called SN-38. Sacituzumab govitecan is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as Tumor-associated calcium signal transducer 2 (TROP2) receptors, and delivers SN-38 to kill them. Another treatment, liposomal doxorubicin, is a form of the anticancer drug doxorubicin that is contained in very tiny, fat-like particles. It may have fewer side effects and work better than doxorubicin, and may enhance factors associated with immune response. The third medication is called binimetinib, which may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and may help activate the immune system. It is not yet known whether giving avelumab in combination with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan will work better in treating patients with triple negative breast cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests the immunotherapy drug avelumab in combination with one of three other drugs (binimetinib, sacituzumab govitecan, or liposomal doxorubicin) in women with advanced triple-negative breast cancer (TNBC) — a type of breast cancer that lacks common hormone receptors, making it harder to treat. **You may be eligible if...** - You are 18 or older - You have stage IV or unresectable triple-negative breast cancer - Your cancer is measurable on scans - Your general health level is good (ECOG 0 or 1) - You can perform normal or light daily activities **You may NOT be eligible if...** - Your breast cancer is not triple-negative - Your cancer is not measurable - Your overall health is too poor - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAnti-OX40 Antibody PF-04518600

Given IV

DRUGAvelumab

Given IV

DRUGBinimetinib

Given PO

BIOLOGICALUtomilumab

Given IV

DRUGLiposomal Doxorubicin

Given IV

DRUGSacituzumab Govitecan

Given IV


Locations(12)

O'Neal Comprehensive Cancer Center

Birmingham, Alabama, United States

University of California, San Francisco

San Francisco, California, United States

Georgetown University

Washington D.C., District of Columbia, United States

University of Chicago Medicine Comprehensive Cancer Center

Evergreen Park, Illinois, United States

Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University

Baltimore, Maryland, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Duke Cancer Institute

Durham, North Carolina, United States

Abramson Cancer Center, University of Pennsylvania

Philadelphia, Pennsylvania, United States

Vanderbilt University Ingram Cancer Center

Nashville, Tennessee, United States

Baylor College of Medicine

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT03971409


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