Evaluating different doses of nivolumab plus ipilimumab for advanced melanoma

This study compared the safety of two different doses of nivolumab (Opdivo) plus ipilimumab (Yervoy) for patients with advanced melanoma. This study concluded that patients treated with nivolumab at 3mg/kg and ipilimumab at 1mg/kg had fewer side effects.

Advanced melanoma can be difficult to treat. Nivolumab and ipilimumab are anti-cancer drugs used to treat advanced melanoma. These drugs are monoclonal antibodies. This type of treatment helps boost the body's immune system to attack cancer cells.

Nivolumab and ipilimumab are typically used together as a first-line treatment for advanced melanoma. The standard doses are 1 mg/kg for nivolumab and 3 mg/kg for ipilimumab. This combination can have some side effects. These may include tiredness, diarrhea, feeling sick, and skin rash. It is not known if 3 mg/kg for nivolumab and 1 mg/kg for ipilimumab lead to fewer side effects for these patients.

This study had 360 patients with advanced melanoma. Half of the patients received nivolumab at 3 mg/kg and ipilimumab at 1 mg/kg (N3+IP1). The other half received nivolumab at 1 mg/kg and ipilimumab at 3 mg/kg (N1+IP3). Patients were treated once every three weeks for four doses. 

After initial treatment, 68.3% (N3+IP1) and 57.3% (N1+IP3) of patients received nivolumab maintenance therapy. This is a low-dose treatment given over a long period of time to keep the cancer from coming back. Patients were followed-up for an average of 18.6 to 18.8 months.

Overall, 45.6% (N3+IP1) and 50.6% (N1+IP3) of patients responded to treatment. Similar numbers of patients in both groups had a complete disappearance of all signs of cancer (15.0% vs. 13.5%).

Overall, patients in the N3+IP1 group survived longer without tumor growth or spread compared to patients in the N1+IP3 group (9.9 months vs. 8.9 months). Slightly more patients in the N1+IP3 group were still alive 1 year later compared to the N3+IP1 group (81.0% vs. 79.7%).

Overall, slightly fewer patients in the N3+IP1 group reported side effects compared to the N1+IP3 group (85.6% vs. 93.8%). However, significantly more patients in the N3+IP1 group had serious side effects compared to the N1+IP3 group (48.3% vs. 33.9%). More patients in the N1+IP3 group stopped treatment due to sided effects (28.1% vs. 17.2%).

The study concluded that treatment with nivolumab at 3mg/kg and ipilimumab at 1mg/kg resulted in fewer side effects in patients with advanced melanoma.

This study was small. Also, the follow-up period was short. As a result, the survival data were not statistically different between the two groups. Larger studies with a longer follow-up are needed to confirm these results.