What the trial was testing
The CheckMate 401 enrolled 533 patients with melanoma. The study was sponsored by Bristol-Myers Squibb and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was a large trial designed to confirm whether the treatment works well enough for wider use. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
71% alive at 2 years even with melanoma brain metastases.
Journal of Clinical Oncology · 2023 · NCT02599402
These findings — that at 24 months on nivolumab + ipilimumab in melanoma with brain metastases — were published in the Journal of Clinical Oncology and represent the headline result of the study.
Researchers tracked outcomes across 533 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with melanoma, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
Nivolumab (Opdivo) plus ipilimumab (Yervoy) is FDA-approved and available now as first-line treatment for advanced melanoma, including patients with brain metastases. Immune-related side effects can be serious and require quick recognition. Ask a melanoma oncologist if you qualify.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open melanoma trials
Safety and Efficacy of EIK1001 in Combo With Pembro Versus Placebo and Pembro as First-Line Therapy in Patients With Advanced Melanoma.
The study is for patients with advanced melanoma who are eligible for standard therapy with Pembrolizumab.
Effects of Anti-PD1 Adjuvant Checkpoint Blockade Immunotherapy on Atypical/Dysplastic Nevi
This study will examine the impact of anti-programmed cell death 1 (PD1) therapy given in the approved adjuvant therapeutic regimens upon the morphologic, histopathologic, molecular and immunologic as well as genomic features of atypical/dysplastic nevi (A/DN) in patients with a prior documented melanoma of Stages IIB, IIC, IIIA, IIIB, or IIIC and concurrent presence of two or more atypical nevi.