Administration of immune checkpoint inhibitors through an elastomeric pump. A patient preference study and cost analysis.

Since their introduction immune checkpoint inhibitors (ICIs) have become standard therapy in a rapidly increasing number of tumor
types and settings.
However, besides the many advantages these ICIs offer, new challenges arise. They put great strains on the available treatment
capacity of outpatient oncology clinics. In recent years a number of oncology monoclonal antibodies have become available as a
formulation for subcutaneous (SC) injection. These SC monoclonal antibodies such as rituximab, trastuzumab and daratumumab
have demonstrated to significantly reduce patient chair time, active healthcare professional (HCP) time, thereby reducing healthcare
costs. In addition to these advantages, they have also shown to be patients preferred method of administration and increase patient
satisfaction.
Recently in the Erasmus MC, positive experiences have been obtained with the use of elastomeric pumps during administration of
chemotherapy. ICI administration through an elastomeric pump (ICI-P) could be a safe and suitable option reduce patient chair time
by enabling patients to move more freely through the hospital during ICI infusion. Based on our own data it is estimated that full
adoption of elastomeric pumps for ICIs could increase the capacity of our outpatient clinic for these patients by 400%. Besides
these economic advantages, patients might also prefer ICI-P over ICI administration using a “classic” IV bag (ICI-B).
Therefore we shall conduct an open-label, randomized, two cohort, two-arm crossover study to investigate the patient preference
and healthcare professional preference for either ICI-B or ICI-P. Parallel to this trial an observational non-interventional microcosting
study shall be conducted.

Significantly more patients will express an overall preference for ICI-P versus ICI-B

Baseline screening 1st cycle ICI-B/ICI-P 2nd cycle ICI-B/ICI-P 3rd cycle ICI-P/ICI-B 4th cycle ICI-P/ICI-B
Medical history X

In- / exclusion criteria X

Provide Information about the study X

Written informed consent X

Nivolumab/Pembrolizumab monotherapy X X X X

Patient satisfaction questionnaire X X

Patient preference questionnaire X

HCP preference questionnaire X

Incidence of infusion site extravasations X X X X

Incidence of infusion related reactions X X X X

Monetary costs of healthcare resources per cycle of ICI-B X X X X

The total chair time required per cycle of ICI-B and ICI-P X X X X

Total and task-specific HCP time required per cycle of ICI-B and ICI-P X X X X

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 randomized 1:1 in group A-B or group B-A. group A-B shall receive 2 cycles ICI-B (hereafter referred to as treatment A) followed by 2 cycles of ICI-P (hereafter referred to as treatment B). Patients in group B-A shall first receive two cycles of treatment B followed by two cycles of treatment A. eligible patients shall complete a questionnaire after two cycles of treatment A and after two cycles of treatment B. All patients will receive a dose of nivolumab every four weeks (Q4W) or pembrolizumab every three weeks (Q3W) or every six weeks (Q6W).