First-Line Nivolumab/Ipilimumab Followed by Nivolumab in a Clinically Diverse Population With Unresectable Stage III or IV Melanoma

Source: The Asco Post, June 2023

In the phase IIIb CheckMate 401 trial reported in the Journal of Clinical Oncology, Reinhard Dummer, MD, and colleagues described outcomes with first-line nivolumab/ipilimumab followed by nivolumab in a clinically diverse population of patients with unresectable stage III or IV melanoma, including patients with a poorer performance status, brain metastases, and different melanoma subtypes.

As stated by the investigators, “Although previous studies demonstrated clinical benefit with immunotherapy in patients with advanced melanoma, there is a paucity of data in patients with poor prognoses who are typically excluded from clinical trials. CheckMate 401 … evaluated the safety and efficacy of first-line nivolumab plus ipilimumab followed by nivolumab in clinically diverse patient populations with unresectable stage III [or] IV melanoma representative of real-life practice.”

Study Details
In the European-Australian trial, 533 patients enrolled between December 2015 and August 2017 were to receive nivolumab at 1 mg/kg plus ipilimumab at 3 mg/kg once every 3 weeks for four doses, followed by nivolumab at 3 mg/kg (240 mg following protocol amendment) once every 2 weeks for up to 24 months. Among the patients, 68% (n = 365) had cutaneous melanoma; 20% had ocular/uveal (n = 64), mucosal (n = 32), or acral (n = 10) melanoma; 10% (n = 55) had an Eastern Cooperative Oncology Group (ECOG) performance status of 2 (including 37 with cutaneous melanoma); and 8% (n = 42) had brain metastases (5% previously treated, 3% untreated).