Solid tumors for which nivolumab or pembrolizumab monotherapy has an EMA approved indication. This includes (but is not limited to) melanoma, renal-cell cancer, NSCLC and head and neck cancer.
Conditions
Interventions
Prior to the study, eligible patients have received a minimum of 3 doses of nivolumab or pembrolizumab without the occurrence of hypersensitivity reactions. Thereafter, eligible patients will be rando
Sponsors
Erasmus MC
Eligibility
Inclusion criteria
Inclusion criteria: - Age =18 years; - Able and willing to give written informed consent; - Planned treatment with Nivolumab or Pembrolizumab monotherapy (in case of Nivolumab with or without prior treatment with Nivolumab/Ipilimumab) for any EMA approved indication and with any dose; - Adequate Dutch language proficiency (at least proficiency level C1) - At least 3 prior cycles of Nivolumab or Pembrolizumab therapy - At least 4 remaining cycles of Nivolumab or Pembrolizumab monotherapy after inclusion in the study.
Exclusion criteria
Exclusion criteria: - Prior infusion related reactions to Nivolumab or Pembrolizumab (any grade).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is the percentage of patients indicating an overall preference for ICI-B or ICI-P. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Patient satisfaction score of ICI-B and ICI-P assessed using the Rituximab Administration Satisfaction Questionnaire (RASQ). - The incidence of infusion site extravasations according to CTCAE v5.0. - The incidence of infusion related reactions according to CTCAE v5.0. - The percentage of HCPs indicating an overall preference for either ICI-B or ICI-P administration. - Monetary costs of health care resources per cycle of ICI-B and ICI-P. - The total chair time required per cycle of ICI-B and ICI-P. - Total and task-specific HCP time required per cycle of ICI-B and ICI-P. | — |
Contacts
Public ContactBirgit Koch
Erasmus MC
Outcome results
None listed