AbataCept for the Treatment of Immune-cHeckpoint Inhibitors Induced mYocarditiS
Status:
Not yet recruiting
Trial end date:
2024-09-01
Target enrollment:
Participant gender:
Summary
Immune-checkpoint-inhibitors (ICI) have revolutionized treatment for 20 cancer types. They
unleash anti-tumor immune responses. Unfortunately, in 0.36-1.23% of patients, this
activation can also lead to lethal immune-related adverse events (irAEs) that can affect any
organ. Among those irAEs, ICI-induced myocarditis are the most frequently fatal with death
rate reaching 50% in a large case-series of over 100 patients.
This study is a dose-finding Phase II trial where 3 abatacept IV regimen (A-10 mg/kg; B-20
mg/kg and C-25 mg/kg every week) will be tested aiming at reaching promptly (after the first
dose) and sustainably a CD86RO≥80% during the first 3 weeks of ICI-myocarditis management.
The main objective is to find the lowest dose required to achieve a circulating monocytes
CD86RO≥80% within the first week of treatment and sustainably over three weeks. The target
population is all adult patients with cancer (all cancer types) treated by immune checkpoint
inhibitors (anti-PD1, anti-PDL1, anti-CTLA4 monotherapies or combination) and presenting
drug-induced myocarditis.