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
Assessment of Skin Lesions Using a Tissue Oxygen Imager Based on Protoporphyrin IX (PPIX) Fluorescence. This is an Open-label, Non-randomized, Feasibility Study That Includes a One-time Application of an FDA Approved Medication Followed by Local Imaging for Benign Skin Growth and Lesions Clinically
The primary objective of this study is the evaluation of the efficacy of the tissue oxygen imager based on PpIX DF in differentiating benign skin growth from non-melanoma skin cancer (NMSC).
Pembrolizumab and Hypofractionated Radiation Therapy for the Treatment of Mucosal Melanoma
This is an open-label, single center, one cohort, non-randomized, phase II study. The aim is to evaluate the efficacy and safety of the combination of hypofractionated radiotherapy (HRT) and pembrolizumab on local tumor control in mucosal melanoma patients. Treatment effect will be compared with historical radiation therapy-alone control data.