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

Phase 4

Recruiting

Conditions: NSCLC and head and neck cancer
renal-cell cancer
Solid or hematological tumors for which Nivolumab or Pembrolizumab monotherapy have an EMA approved indication. This includes (but is not limited to) melanoma
Various forms of cancer for which Nivolumab or Pembrolizumab monotherapy are prescribed as treatment
10027656

Registration Number: NL-OMON54425

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 390

Inclusion Criteria

- Age >=18 years;
- Able and willing to give written informed consent;
- Planned treatment with nivolumab or pembrolizumab monotherapy (subjects
treated with nivolumab/ipilimumab combination treatment can participate in the
trial on days during which they receive nivolumab monotherapy) or any other EMA
approved ICI as monotherapy for any EMA approved indication and with any dose;
- Adequate Dutch language proficiency (at least proficiency level C1)
- At least 2 prior cycles of Nivolumab or Pembrolizumab therapy
- At least 4 remaining cycles of Nivolumab or Pembrolizumab monotherapy after
inclusion in the study.

Exclusion Criteria

Prior infusion related reactions to Nivolumab or Pembrolizumab (any grade).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of this study is the percentage of patients indicating an<br /><br>overall preference for ICI-B or ICI-P.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Patient satisfaction score of ICI-B and ICI-P assessed using the Rituximab<br /><br>Administration Satisfaction Questionnaire (RASQ)<br /><br>- The incidence of IRRs according to CTCAE v5.0.<br /><br>- The incidence of infusion site extravasations according to CTCAE v5.0.<br /><br>- The percentage of HCPs indicating an overall preference for either ICI-B or<br /><br>ICI-P administration.<br /><br>- Monetary costs of health care resources per cycle of ICI-B and ICI-P.<br /><br>- The total chair time required per cycle of ICI-B and ICI-P.<br /><br>- Total and task-specific HCP time required per cycle of ICI-B and ICI-P.</p><br>