MSHLIpilimumab Injection Concentrate 50 mg/ 10 mL
1) Nivolumab in combination with ipilimumab for untreated intermediate- or poor-risk advanced renal cell carcinoma. The doses of nivolumab and ipilimumab should not exceed: 3mg/kg nivolumab and 1mg/kg ipilimumab every 3 weeks for 4 doses.
2) Nivolumab in combination with ipilimumab for the treatment of advanced unresectable or metastatic malignant melanoma. The doses of nivolumab and ipilimumab should not exceed: 1mg/kg nivolumab and 3mg/kg ipilimumab every 3 weeks for 4 doses.
3) Nivolumab in combination with ipilimumab for unresectable malignant pleural mesothelioma. Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for this condition. The doses of nivolumab and ipilimumab should not exceed: 3mg/kg nivolumab every 2 weeks and 1mg/kg ipilimumab every 6 weeks. Treatment with nivolumab and ipilimumab should be stopped at 2 years, or earlier if disease progresses.
4) Nivolumab in combination with ipilimumab for untreated, unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma. The doses of nivolumab and ipilimumab should not exceed: 3mg/kg nivolumab every 2 weeks and 1mg/kg ipilimumab every 6 weeks. Treatment with nivolumab and ipilimumab should be stopped at 2 years, or earlier if disease progresses.
5) Nivolumab in combination with ipilimumab for treatment of unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for unresectable or metastatic MSI-H or dMMR CRC. The doses of nivolumab and ipilimumab should not exceed: 3mg/kg nivolumab and 1mg/kg ipilimumab every 3 weeks for 4 doses, followed by nivolumab 240mg every 2 weeks or 480mg every 4 weeks as a single agent.
6) Nivolumab in combination with ipilimumab for treatment of advanced unresectable hepatocellular carcinoma (HCC) in patients with disease progression after 1 or more prior lines of systemic therapy, and who have adequate liver function as assessed by the Child-Pugh scoring system. Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for advanced unresectable HCC. The doses of nivolumab and ipilimumab should not exceed: 1mg/kg nivolumab and 3mg/kg ipilimumab every 3 weeks for 4 doses, followed by nivolumab 240mg every 2 weeks or 480mg every 4 weeks as a single agent.
7) Nivolumab in combination with ipilimumab and 2 cycles of platinum-based chemotherapy, for untreated metastatic or recurrent non-small cell lung cancer (NSCLC) in patients with no EGFR or ALK genomic tumour mutations. Treatment with nivolumab and ipilimumab should be stopped at 2 years, or earlier if disease progresses.