Use the hyperlinks, where available to access additional clinical trial information.
A Phase Ib/II Trial of Ipilimumab-Nivolumab-Denosumab and Nivolumab-Denosumab in Patients with Unresectable Stage III and IV Melanoma
Other Non-Commercial Sponsor
Peter MacCallum Cancer Centre
This is a randomised controlled trial.
Patients in Arm A of the trial, will receive intravenous (IV) nivolumab (3 mg/kg IV) every 2 weeks for 4 doses and subcutaneous (SC) denosumab (120 mg) on D1, D8, D15 and D29. Thereafter, IV nivolumab (480 mg) and SC denosumab (120 mg) every 4 weeks for a total of 24 months
Patients in Arm B will recieve ipilimumab (3 mg/kg) in combination with nivolumab (1 mg/kg IV) every 3 weeks for 4 doses, with SC denosumab (120 mg) given on D1, D8, D15, D29, D57. This will be followed by nivolumab 480 mg IV and denosumab 120 mg SC ever 4 weeks for a total of 24 months.
Responses to treatment and progression will be regularly monitored until the last patient has been in survival follow-up for 5 years. Tumour and blood samples will also be taken to determine possible predictive biomarkers.