Solid tumors for which nivolumab or pembrolizumab monotherapy is an EMA approved indication. This includes (but is not limited to) melanoma, renal-cell cancer, NSCLC and head and neck cancer.
Conditions
Interventions
Trade Name: Opdivo
Product Name: Nivolumab
Pharmaceutical Form: Concentrate for concentrate for solution for infusion
Trade Name: Keytruda
Product Name: Pembrolizumab
Pharmaceutical Form: Concentrate
Sponsors
Erasmus MC Cancer Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age =18 years - Able and willing to give written informed consent - Planned treatment with nivolumab or pembrolizumab monotherapy (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 in medical history - At least 4 remaining cycles of nivolumab or pembrolizumab monotherapy after inclusion in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 312 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 78
Exclusion criteria
Exclusion criteria: Prior hypersensitivity reactions to nivolumab or pembrolizumab (any grade).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the patient preference for either Immune Checkpoint Inhibitor (ICI) administered through an IV bag (hereafter called ICI-B) or ICI administration through an elastomeric pump (hereafter called ICI-P) in patients with a standard of care indication for ICI monotherapy.;Secondary Objective: Secondary objectives are: - to assess patient satisfaction with ICI-B and ICI-P - to establish the safety of ICI-B and ICI-P - to establish the healthcare professional preference for ICI-B or ICI-P - to perform a cost analysis. ;Primary end point(s): The percentage of patients indicating an overall preference for Nivolumab or Pembrolizumab administration via an elastomeric pump (ICI-P) or via an iv bag (ICI-P).;Timepoint(s) of evaluation of this end point: This endpoint shall be evaluated after the last of the four cycles of study treatment with nivolumab or pembrolizumab. Subjects shall fill out a questionnaire in which they, amongst other topics, express their overall preference for either method of administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints are: - Patient satisfaction score of ICI-B and ICI-P assessed using the Rituximab Administration Satisfaction Questionnaire (RASQ) - The incidence of IRRs according to CTCAE v5.0. - The incidence of infusion site extravasations 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. ;Timepoint(s) of evaluation of this end point: All secondary endpoints except patient satisfaction are evaluated continuously throughout the trial during the four cycles of nivolumab or pembrolizumab treatment during the study. Patient satisfaction is assessed directly after study treatment cycle number 2 and 4 using the RASQ. | — |
Countries
Netherlands
Contacts
Public ContactR. Malmberg
Erasmus MC Cancer Institute
Outcome results
None listed