Nivolumab Plus Ipilimumab for Treatment‑Naïve Metastatic Uveal Melanoma: An Open‑Label, Multicenter, Phase II Trial
Combination therapy with nivolumab and ipilimumab improves 12‑month overall survival for patients with metastatic uveal melanoma, surpassing historical chemotherapy benchmarks and maintaining a manageable toxicity profile.
This single‑arm, phase II trial evaluated first‑line nivolumab (1 mg/kg q3 wk, then 3 mg/kg q2 wk) plus ipilimumab (3 mg/kg q3 wk) in 52 treatment‑naïve patients with metastatic uveal melanoma (MUM). The primary endpoint was 12‑month overall survival (OS). Results showed a 12‑month OS of 51.9 % (95 % CI 38.3–65.5) with a median OS of 12.7 months and median progression‑free survival of 3.0 months. Stable disease was observed in 51.9 % of patients and liver involvement was common. Toxicity was manageable. The study suggests nivolumab plus ipilimumab offers a modest OS benefit over historical chemotherapy controls.
Advancing systemic therapy options for metastatic uveal melanoma—a highly aggressive subtype with limited effective treatments—could improve survival outcomes and establish immunotherapy as a standard first‑line approach.
Bizonyítékszint: Korai humán adat. Kis vagy feltáró emberi adat.
Kapcsolódó jelek
- Beyond the Five-Year Milestone: Long‑term Survivorship of Melanoma Patients Treated Off‑Trial with anti‑PD‑1
- Uveal Melanoma – Trials in Disease – Overview of Information and Clinical Research
- A phase 1/2 trial of an immune-modulatory vaccine against IDO/PD-L1 in combination with nivolumab in metastatic melanoma
- Melanoma Research
- The Clinical Trial Landscape for Melanoma Therapies