Immune checkpoint inhibitors (ICI) have improved the long-term survival of patients with metastatic tumors. However, approximately 50% of the patients treated with ICI develop serious immune-related adverse events (irAE). A recent study reported that grade 3 or higher irAE occurred in 49 of 124 patients (39.5%) who received nivolumab/ipilimumab and in 41 of 123 patients (33.3%) who received nivolumab alone. Other studies report an overall frequency of grade 3-5 irAE in 24% - 59% of patients treated with nivolumab 1 mg/kg body weight and ipilimumab 3 mg/kg body weight. An incidence of 33.3% was reported when patients were treated with nivolumab 3 mg/kg body weight and ipilimumab 1 mg/kg body weight. The most common events reported during combined ICI treatment are diarrhea, rash, pruritus, hepatitis, hypothyroidism, neurological disease and pneumonitis. These numbers show that irAE are a particularly frequent complication of ICI and limit their use.~Preliminary data demonstrate that irAEs induced by immune checkpoint blockade can be successfully treated with ECP (Apostolova et al. NEJM 2020). Therefore this clinical phase 1/2 trial is launched to validate the finding made with the individual patient in a prospective trial. The primary objective is evaluation of safety of ECP treatment in patients with irAEs. As a secondary objective, the study will determine the efficacy of ECP as a treatment for immune-related adverse events and its effect on tumor progression.
Preliminary data demonstrate that irAEs induced by immune checkpoint blockade can be successfully treated with ECP (Apostolova et al. NEJM 2020). Therefore this clinical phase 1/2 trial is launched to validate the finding made with the individual patient in a prospective trial. The primary objective is evaluation of safety of ECP treatment in patients with irAEs. As a secondary objective, the study will determine the efficacy of ECP as a treatment for immune-related adverse events and its effect on tumor progression.