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.

The primary objective of this study is to evaluate the patient preference for
either ICI-B or ICI-P. 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, and to perform a
cost analysis.

This study is a prospective, open-label, randomised, two-cohort, two-arm,
crossover, patient preference study.

Prior to the study, eligible patients have received a minimum of 2 cycles of
ICI treatment without the occurrence of hypersensitivity reactions. Thereafter,
eligible patients will be randomized 1:1 to receive either 2 cycles ICI-B
followed by 2 cycles of ICI-P (A-B), or 2 cycles of ICI-P followed by 2 cycles
of ICI-B (B-A).

Patients will be treated with Nivolumab or Pembrolizumab as standard of care.
The only additional burden for patients during participation in this trial are
the three questionnaires that need to be completed during the trial. The RASQ
is required to be completed twice (after 2nd and 4th administration of
Nivolumab/Pembrolizumab) during trial and the patient preference Questionnaire
is required to be completed after the last ICI administration during the trial.

Patients will be admitted to the outpatient clinic conform standard of care and
they will be randomized into two groups. Prior to the study, eligible patients
have received a minimum of 2 cycles of ICI treatment without the occurrence of
hypersensitivity reactions. Major risks are not expected during this study.
Nonetheless, we will carefully observe all included patients, during the whole
study period, conform standard of care.