Immune related adverse events induced by treatment with immunotherapy
Conditions
Brief summary
To evaluate the rate of treatment-related adverse events (AEs) and serious adverse events (SAEs) in patients treated with ECP for immunecheckpoint inhibitor-induced colitis, pneumonitis, hepatitis or dermatitis. A positive result from the study is defined as ≤50% of the patients developing a treatment-related SAE.
Detailed description
Key secondary endpoints: • To evaluate the investigator-assessed objective response rate (ORR) to treatment after 6 and 12 weeks of ECP therapy The response criteria for each organ are described in chapter 6.2. • To assess time to response • To assess the duration of investigator-assessed clinical response • To assess overall survival (OS) at 1 year after end of ECP treatment • To measure the time to complete discontinuation of other immunosuppressive therapy
Interventions
Sponsors
Medical Center - University Of Freiburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the rate of treatment-related adverse events (AEs) and serious adverse events (SAEs) in patients treated with ECP for immunecheckpoint inhibitor-induced colitis, pneumonitis, hepatitis or dermatitis. A positive result from the study is defined as ≤50% of the patients developing a treatment-related SAE. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary endpoints: • To evaluate the investigator-assessed objective response rate (ORR) to treatment after 6 and 12 weeks of ECP therapy The response criteria for each organ are described in chapter 6.2. • To assess time to response • To assess the duration of investigator-assessed clinical response • To assess overall survival (OS) at 1 year after end of ECP treatment • To measure the time to complete discontinuation of other immunosuppressive therapy | — |
Countries
Germany
Outcome results
None listed