Spots Global Cancer Trial Database for Study of Ipilimumab, Nivolumab, and Cabozantinib in Patients With Cutaneous Melanoma

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Trial Identification

Brief Title: Study of Ipilimumab, Nivolumab, and Cabozantinib in Patients With Cutaneous Melanoma

Official Title: A Phase II, Single-Arm Clinical Trial Evaluating the Triplet Combination of Ipilimumab, Nivolumab, and Cabozantinib in Patients With Anti-PD-1(L1) Refractory Cutaneous Melanoma

Study ID: NCT05200143

Conditions

Refractory Cutaneous Melanoma

Interventions

Ipilimumab

Nivolumab

Cabozantinib

Study Description

Brief Summary: The primary objective of this clinical trial is to evaluate the clinical efficacy and progression free survival of the triplet combination of ipilimumab + nivolumab + cabozantinib in patients with anti-PD-1/PD-L1 refractory metastatic cutaneous melanoma.

Detailed Description: This is a phase II, single arm, single institution clinical trial. Eligible adults with anti-PD-1 refractory, unresectable/metastatic cutaneous melanoma will be treated with the triplet combination of ipilimumab 1 mg/kg + nivolumab 3 mg/kg every 3 weeks for 4 cycles in addition to cabozantinib 40 mg/day. For cycles 5+, treatment will consist of nivolumab 480 mg IV every 4 weeks in combination with cabozantinib 40 mg/day. The total duration of therapy will be 24 months or until either disease progression or the occurrence of unacceptable drug-related toxicity. Regular tumor assessments should be performed to determine if PD is present.