2. Progression-free survival at 6 months (PFS6m, proportion alive and progression-free at 6 months, RECIST 1.1, iRECIST)
3. OTRR and disease control (DCR = CR, PR, or SD at 6 months, iRECIST) rate (DCRR)
4. Time to objective tumour response (OTR), duration of OTR (RECIST 1.1 and iRECIST)
5. Time to first skeletal related event (SRE)
6. Frequency and severity of adverse events (CTCAE v4.03), particularly selected immune-related adverse events (IRAE)
7. Frequency of treatment delays and discontinuation due to toxicity
8. Associations between clinical outcomes and possible prognostic and/or predictive biomarkers (tissue and circulating) including those related to immune and RANK/L signalling.