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Nivolumab and Ipilimumab in Metastatic Uveal Melanoma: Results From a Single-Arm Phase II Study
Meredith S Pelster1, Stephen K Gruschkus2, Roland Bassett2
1Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.
Purpose:
Metastatic uveal melanoma has poor overall survival (OS) and no approved systemic therapy options. Studies of single-agent immunotherapy regimens have shown minimal benefit. There is the potential for improved responses with the use of combination immunotherapy.
Patients And Methods:
We conducted a phase II study of nivolumab with ipilimumab in patients with metastatic uveal melanoma. Any number of prior treatments was permitted. Patients received nivolumab 1 mg/kg and ipilimumab 3 mg/kg for four cycles, followed by nivolumab maintenance therapy for up to 2 years. The primary outcome of the study was overall response rate (ORR) as determined by RECIST 1.1 criteria. Progression-free survival (PFS), OS, and adverse events were also assessed.
Results:
Thirty-five patients were enrolled, and 33 patients were evaluable for efficacy. The ORR was 18%, including one confirmed complete response and five confirmed partial responses. The median PFS was 5.5 months (95% CI, 3.4 to 9.5 months), and the median OS was 19.1 months (95% CI, 9.6 months to NR). Forty percent of patients experienced a grade 3-4 treatment-related adverse event.
Conclusion:
The combination regimen of nivolumab plus ipilimumab demonstrates activity in metastatic uveal melanoma, with deep and sustained confirmed responses.
Insights
Combination immunotherapy with nivolumab and ipilimumab shows promise for metastatic uveal melanoma, offering improved response rates and survival. This approach provides a potential new treatment option for patients with this rare cancer.
Area of Science:
- Oncology
- Immunotherapy
- Melanoma Research
Background:
- Metastatic uveal melanoma has a poor prognosis with limited systemic therapy options.
- Single-agent immunotherapies have demonstrated minimal efficacy in this patient population.
- Combination immunotherapy presents a potential strategy for enhanced treatment responses.
Purpose of the Study:
- To evaluate the efficacy and safety of a combination regimen of nivolumab and ipilimumab in patients with metastatic uveal melanoma.
- To determine the overall response rate (ORR) as the primary endpoint.
- To assess progression-free survival (PFS), overall survival (OS), and adverse events.
Main Methods:
- A phase II study was conducted enrolling 35 patients with metastatic uveal melanoma.
- Patients received nivolumab (1 mg/kg) plus ipilimumab (3 mg/kg) for four cycles, followed by nivolumab maintenance.
- Response was assessed by RECIST 1.1 criteria; PFS, OS, and adverse events were monitored.
Main Results:
- The overall response rate (ORR) was 18% (1 complete response, 5 partial responses) among 33 evaluable patients.
- Median progression-free survival (PFS) was 5.5 months, and median overall survival (OS) was 19.1 months.
- Grade 3-4 treatment-related adverse events occurred in 40% of patients.
Conclusions:
- The combination of nivolumab and ipilimumab demonstrates clinical activity in metastatic uveal melanoma.
- This regimen yields deep and sustained responses in a subset of patients.
- Combination immunotherapy offers a potential therapeutic advance for metastatic uveal melanoma.
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