Table 3.

During treatment assessment

• Physical examination including oxygen saturation, performance status (ECOG), assessment of toxicity, concomitant medication

• Laboratory tests (hematology and chemistry panel), including

• Free T3/T4 and TSH (every 6 weeks)

• Pregnancy test for women of childbearing potential (every 4 weeks)

• Quality of life assessment (EORTC QLQ-C30 and STO-22) every 2 months (together with imaging)

• Blood draw for translational research (cycle 2, cycle 4/5 [Arm A/B] and progression and/or end of treatment)

• Echocardiography every 3 months

• Disease assessment by radiological imaging of the chest, abdomen, pelvis and all other sites of disease (CT/MRI-scan) every 8 weeks for up to 12 months and thereafter 3 monthly

• Quality of life will be assessed using the EORTC QLQ-C30 and STO-22 every 8 weeks together with tumor response assessment

Additional assessments during treatment with nivolumab, ipilimumab and trastuzumab in arm A until week 13 on day 12 of every cycle (+/−3 days)

• Physical examination including oxygen saturation, performance status (ECOG), assessment of toxicity, concomitant medication

• Laboratory tests (hematology and chemistry panel)