A single-arm study of the treatment of high-risk tumors with nivolumab and entinostat in children and adolescents
So-called high-risk tumors often progress very rapidly despite optimal treatment and are usually resistant to standard therapies. Immunotherapies and targeted drugs, such as the study drugs nivolumab and entinostat, offer new hope. Previous studies suggest that this combination may inhibit tumor growth in tumors with specific genetic characteristics. The goal of the INFORM2 study is to to investigate the efficacy of the combination therapy of nivolumab and entinostat in children and adolescents with treatment-resistant or recurrent high-risk tumors, and to compare whether the efficacy of this combination therapy differs in tumors with specific genetic alterations compared to those without these characteristics. Patients between the ages of 2 and 21 with a brain tumor or solid tumor classified as high-risk are eligible to participate. The tumor must either have a myc(n) amplification, a high mutation burden, or high PD-L1 expression—or none of these characteristics.
2–21 years · Relapsed / refractory · Phase I/II
