Anatomic Stage IV Breast Cancer AJCC v8 Clinical Trial
Official title:
A Phase Ib Trial of M7824 and Eribulin in Patients With Metastatic Triple Negative Breast Cancer (TNBC)
This phase Ib trial studies the best dose and side effects of eribulin mesylate when given together with M7824)in treating patients with triple negative breast cancer that has spread to other places in the body. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as M7824, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving eribulin mesylate and M7824 may work better at treating triple negative breast cancer.
PRIMARY OBJECTIVES: I. To determine the recommended phase II dose (RP2D) of eribulin mesylate (eribulin) when in combination with the fixed dose of bintrafusp alfa (M7824) in patients with metastatic triple-negative breast cancer (TNBC). II. To evaluate the safety and tolerability of M7824 when in combination with eribulin in patients with metastatic TNBC. SECONDARY OBJECTIVES: I. To determine the best overall response (BOR) rate according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. II. To determine the overall response rate (ORR). OTHER OBJECTIVES: I. To assess immunologic/molecular responses to M7824 in combination with eribulin in patients with metastatic TNBC. II. Estimation of progression-free survival (PFS) in metastatic TNBC patients treated with M7824 in combination with eribulin. III. Perform correlative studies on blood and tissue samples to evaluate systemic and tumor biomarkers of response and resistance to M7824 and eribulin. IV. Correlative studies on blood and tissue samples will also be used to evaluate systemic and tumor biomarkers of response to M7824 and eribulin. OUTLINE: Patients receive bintrafusp alfa intravenously (IV) over 50-80 minutes on days 1, 15, and 29, and eribulin mesylate IV over 2-5 minutes on days 1, 8, 22, and 29. Treatment repeats every 42 days for up to 1 year in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 90 days. ;
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