| • Patients with locally advanced or metastatic cancers for which ICIs are SOC |
| • WHO Performance Status 0 or 1 |
| • ≥18 years of age |
| • Adequate normal organ and marrow function: |
| a) Haemoglobin ≥90 g/L |
| b) Neutrophil count ≥1.5 × 109/L |
| c) Platelet count ≥100 × 109/L |
| d) Bilirubin ≤1.5 × ULN |
| e) Aspartate aminotransferase/Alanine Aminotransferase ≤3 × ULN |
| f) eGFR >40 mL/min |
| • Resting 12-lead ECG with corrected QT interval <450 ms |
| • Following trial's contraception procedure |
| • Evidence of post-menopausal status or negative serum human chorionic gonado-trophin (HCG) pregnancy test for female pre/peri-menopausal patients |
| Inclusion Criteria – Cohort Specific |
| Renal |
| • Patients with unresectable locally advanced or metastatic renal cell carcinoma |
| (including clear cell and papillary histology) |
| • Intermediate or poor risk as defined in the International Metastatic Renal Cell |
| Carcinoma Database Consortium criteria (prior to the initial 12 weeks treatment |
| with ICI combination) |
| • No evidence of progression on ipilimumab and nivolumab induction therapy and |
| due to commence maintenance nivolumab |
| Melanoma |
| • Patients with locally advanced or metastatic melanoma. |
| • No evidence of progression on ipilimumab and nivolumab induction therapy and |
| due to commence maintenance nivolumab |
| OR |
| • Patients have received single agent pembrolizumab first line for 12 weeks, with no |
| evidence of progression and are due to commence maintenance pembrolizumab |
| every 6 weeks |
