Study Participants
renal, hepatic, and cardiac function, tumor, stage disease, Tumors, human immunodeficiency virus, Cancer
CANCER, DISEASE PROGRESSION, TUMOR, HEPATITIS B, HUMAN IMMUNODEFICIENCY VIRUS, METASTATIC TUMOR, DISEASE, TUMORS, ONCOLOGY, METASTATIC MELANOMA
Subjects were identified through the medical oncology clinical practices of the Abramson Cancer Center at the University of Pennsylvania (Philadelphia, PA), affiliated hospitals, and through referrals from outside hospitals and physicians. Eligible patients were adults ages ≥18 years with unresectable or mTNBC, as defined by lack of expression of the estrogen and progesterone receptors and lack of HER2 overexpression, or unresectable or metastatic melanoma. Tumors were required to have cMET expression in at least 30% of tumor cells (felt to represent at least moderate expression) based on IHC analysis at the University of Pennsylvania (Philadelphia, PA) performed on a primary or metastatic tumor sample either from screening biopsy or archival slides. Subjects were required to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, measurable disease as per RECIST version 1.1 in addition to a second site of disease accessible for biopsy or surgical resection, and disease progression on at least one prior therapy for advanced stage disease. Subjects were not required to have disease progression at the time of study enrollment. Adequate hematologic, renal, hepatic, and cardiac function was required and was defined by a serum creatinine ≤1.5 times upper limit of normal; total bilirubin, aspartate aminotransferase, and alanine aminotransferase ≤2 times upper limit of normal; and cardiac ejection fraction of ≥40% by echocardiogram. If prior immunotherapy was received, the last administered treatment was required to be received at least 2 weeks prior to study enrollment; prior genetically modified T cells were not permitted. Individuals with human immunodeficiency virus, active hepatitis B or C, or comorbidities felt to interfere with protocol compliance or interpretation of study results were excluded from study participation.The clinical trial protocol was approved by the Institutional Review Board at the University of Pennsylvania (Philadelphia, PA). All participants provided written informed consent prior to the conduct of any study-related procedures. The study was conducted in accordance with the FDA regulations, the International Conference on Harmonization Guidelines for Good Clinical Practice, and the Declaration of Helsinki.