This phase II trial studies how well avelumab in combination with binimetinib, utomilumab, or anti-OX40 antibody PF-04518600 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 patients 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. Patients on this trial will receive two weeks of treatment with one of three treatments to stimulate the bodies immune system, including the monoclonal antibodies, utomilumab, and the anti-OX40 antibody PF-04518600 which may help the body's immune system attack the cancer, and could interfere with the ability of tumor cells to grow and spread. The third medication is called binimetinib ,
You will be randomly (like the flip of a coin) placed into one of three groups: 1) avelumab with liposomal doxorubicin, 2) avelumab with liposomal doxorubicin and binimetinib, or 3) avelumab with sacituzumab govitecan. The treatment part of this study is when you receive the study drug(s). Before starting the treatment part of the study, you will be given a separate consent form. Study Procedures: The main screening procedures include a physical exam, pregnancy testing (for women of childbearing potential), blood collection, CT, MRI scan, or ultrasound, and tumor tissue biopsy. The screening procedures will take about 6-7 hours. After screening, you will be randomly assigned by chance (like the flip of a coin) to a study treatment group. If you consent to participate in the treatment part, you will receive study drug(s) as long as your disease is not getting worse, and you do not have any bad side effects. The study involves blood draws, physical exams, receipt of study drugs, imaging scans, questionnaires and ECHO or MUGA. You will meet with a member of the study team in addition to your oncology care team during your visits.
Requirements for healthy volunteers are different than for those with a specific condition. If you are interested in becoming a healthy volunteer for this study, use the below categories to determine if you are able to participate.
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA
Yara Abdou
LCCC - Clinical Trials
Clinical or Medical
Interventional
Cancer (Breast)
19-2355
Copyright © 2013-2022 The NC TraCS Institute, the integrated home of the NIH Clinical and Translational Science Awards (CTSA) Program at UNC-CH. This website is made possible by CTSA Grant UL1TR002489 and the National Center for Advancing Translational Sciences.
Questions?
