BI-754091 and Afatinib for Refractory Esophageal Squamous Cell Carcinoma (BEAR Study)

You may not qualify if:

• Any investigational treatment, anti-tumour treatment within 4 weeks or within 5 half-life periods (whichever is shorter) prior to the initiation of trial treatment.
• Major surgery ('major' according to the Investigator's assessment) performed within 12 weeks prior to first trial treatment or planned within 12 weeks after screening, e.g., hip replacement.
• Any of the following cardiac criteria:
• Mean resting corrected QT interval (QTc) \>470 msec.
• Any clinically important abnormalities (as assessed by the Investigator) in rhythm, conduction, or morphology of resting ECGs, e.g., complete left bundle branch block, third degree heart block.
• Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age, or any concomitant medication known to prolong the QT interval.
• Patients with an ejection fraction (EF) \<55% or the lower limit of normal of the institutional standard (if the lower limit of normal of institutional standard is higher than 55%) will be excluded. Only in cases where the Investigator (or the treating physician or both) suspects cardiac disease with negative effect on the EF will the EF be measured during screening using an appropriate method according to local standards to confirm eligibility (e.g., echocardiogram, multi-gated acquisition scan). An historic measurement of EF no older than 6 months prior to first administration of trial drug can be accepted provided that there is clinical evidence that the EF value has not worsened since this measurement in the opinion of the Investigator or of the treating physician or both.
• Known history of human immunodeficiency virus infection.
• Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy.
• Known history of severe hypersensitivity reactions to other mAbs or known hypersensitivity to the trial drugs or their excipients.
• Known presence of symptomatic central nervous system (CNS) metastases, unless asymptomatic and off corticosteroids and anti-convulsant therapy for at least 2 weeks prior start of treatment.
• Immunosuppressive corticosteroid doses (\>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of study treatment.
• Men who plan to father a child while in the trial and for at least 6 months after the last administration of trial medication.
• Other malignancy within the past 5 years except for adequately treated basal or squamous cell skin cancer or cervical cancer in situ.
• Previously treated with any PD-1 inhibitors, PD-L1 inhibitors, or CTLA-4 inhibitors.
• +10 more criteria