What question did this study set out to answer?

This research aims to evaluate the effectiveness and safety of nivolumab combined with ipilimumab in patients with metastatic melanoma.

April 20, 2026Open Access

Clinical activity and safety of nivolumab in combination with ipilimumab in metastatic melanoma: findings from REALIPINIVO, a real-world study

Key Points

This research aims to evaluate the effectiveness and safety of nivolumab combined with ipilimumab in patients with metastatic melanoma.
Conducted a real-world study across six academic centers in southern Italy.
Analyzed outcomes in 72 metastatic melanoma patients.
Focused on efficacy and toxicity of nivolumab and ipilimumab combination.”],
results
achieved objective response rate of 54% (39 out of 72 patients).
Median progression-free survival was extended to 17.03 months (95% CI 4.8-18.6).
Better survival was linked to objective responses and lower disease burden.
all patients with objective responses had high or intermediate tumor mutational burden.
Immune-related adverse events were similar to literature comparisons, yet therapy discontinuation rates were lower.

Abstract

Introduction Metastatic melanoma has historically had a poor prognosis; however, survival has improved with immunotherapies, such as PD−1 and CTLA−4 inhibitors, and molecular targeted therapies for BRAF−mutant tumors. The combination of nivolumab and ipilimumab is highly effective, though with increased rates of toxicity. In Italy, since January 2022, such therapeutic combination has been approved and reimbursed only for metastatic melanoma patients with brain metastases or with PD−L1 expression 1%. Methods We conducted a real-world study in six academic centers in southern Italy and analyzed the efficacy and toxicity outcomes in 72 patients. Results The response rate was 54% (39/72) and, after 13.6 months of median follow-up, a longer median progression-free survival 17.03 months (95% CI 4.8-18.6) compared to the pivotal CheckMate-067 trial or to other real-world studies. Better survival correlated with objective responses (p0.0001) and low disease burden (less than three metastatic sites) (p=0.0415). All patients achieving an objective response had tumors with high or intermediatetumor mutational burden. The rates of immune-related adverse events were similar to those reported in the literature, but there was a lower therapy discontinuation rate. This might be due to more appropriate managing of emerging immunotherapy toxicities.

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