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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a case series, a 76-year-old woman (Case 1) and an 85-year-old man (Case 2) were described, who developed active Mycobacterium tuberculosis (MTB) while receiving immunotherapy with ipilimumab/nivolumab, nivolumab, atezolizumab or cobimetinib [routes not stated] for melanoma.
Case 1: A 76-year-old woman, who had advanced melanoma, was enrolled in a clinical trial (Study no: NCT03068455). She was randomised to receive monotherapy with nivolumab 240mg every 2 weeks against the combination of ipilimumab/nivolumab 1 mg/kg every 3 weeks. Her medical history was significant for smoking, dyslipidemia, hypertension, coronary artery disease and osteopenia. In January 2018, following 8 doses of immunotherapy, she presented with grade 2 diarrhoea and started oral methylprednisolone 16mg...
- Anastasopoulou A, et al. Reactivation of tuberculosis in cancer patients following administration of immune checkpoint inhibitors: Current evidence and clinical practice recommendations. Journal for ImmunoTherapy of Cancer 7: 239, No. 1, 4 Sep 2019. Available from: URL: http://doi.org/10.1186/s40425-019-0717-7 - Greece