According to a study published in the Journal of Clinical Oncology, combining nivolumab with ipilimumab is safe, efficacious, and potentially improves overall survival (OS) among patients with metastatic renal cell carcinoma (mRCC).1
Previous studies show that combining nivolumab, a PD-1 inhibitor, and ipilimumab, a CTLA-4 inhibitor, leads to improved outcomes in metastatic melanoma and lung cancer. The evidence from these studies led the authors to investigate the potential benefit of the combination in mRCC.
In the phase 1, dose-escalation CheckMate-016 study (ClinicalTrials.gov Identifier: NCT01472081), investigators randomly assigned patients into 3 arms: nivolumab 3mg/kg plus ipilimumab 1mg/kg (N3I1), nivolumab 1mg/kg plus ipilimumab 3mg/kg (N1I3), or nivolumab 3mg/kg plus ipilimumab 3mg/kg (N3I3).
Each treatment was administered every 3 weeks for up to 4 doses intravenously (IV) followed by nivolumab 3mg/kg IV monotherapy every 2 weeks until disease progression or intolerable toxicity.
The N3I1 and N1I3 arms had a 40.4% overall response rates (ORR), with ongoing responses in 42.1% of patients in the N3I1 arm vs 36.8% in the N1I3 arm. The 2-year OS was 67.3% in the N3I1 arm vs 69.9% in the N1I3 arm.
Grade 3 or 4 adverse effects (AE) were reported in 38.3% in the N3I1 arm vs 61.7% of patients in the N1I3 arm.
There were no confirmed responses in the N3I3 arm due to a high censoring percentage.
The study authors concluded that “the encouraging safety results in patients treated with the N3I1 combination regimen support the additional clinical investigation of N3I1 in a phase  study for patients with mRCC.”
- Hammers HJ, Plimack ER, Infante JR, et al. Safety and efficacy of nivolumab in combination with ipilimumab in metastatic renal cell carcinoma: the checkmate 016 study. J Clin Oncol. 2017 Jul 6. doi: 10.1200/JCO.2016.72.1985 [Epub ahead of print]