A Phase II Sequential Treatment Trial of Single Agent Nivolumab, Then Combination Ipilimumab + Nivolumab in Metastatic or Unresectable Non-Clear Cell Renal Cell Carcinoma (ANZUP1602).

Open-label, single-arm, phase 2 clinical trial that recruited adults with immunotherapy-naïve, advanced nccRCC. Key eligibility criteria included target lesion(s) according to RECIST 1.1, good performance status (ECOG 0-1), no history of significant autoimmune disease and tumour sample available (previously resected or fresh biopsy). Participants received nivolumab 240 mg i.v. two-weekly for up to 12 months (Part 1), followed by sequential addition of ipilimumab 1 mg/kg three-weekly for four doses to nivolumab if disease progression occurred during treatment (Part 2). Total of 83 participants were eligible for Part 1, including people with papillary (37/83, 45%), chromophobe (15/83, 18%) and other nccRCC subtypes (31/83, 37%); 41 participants enrolled in Part 2. Primary endpoint: objective tumour response rate (OTRR) Secondary endpoints included: duration of response (DOR), progression-free (PFS) and overall survival (OS), and toxicity (treatment-related adverse events).