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

• Conditions: 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.

• Registration Number: NL-OMON25676
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• 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 (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

- 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
The primary endpoint of this study is the percentage of patients indicating an overall preference for ICI-B or ICI-P.

Secondary Outcome Measures

Name	Time	Method
- Patient satisfaction score of ICI-B and ICI-P assessed using the Rituximab Administration Satisfaction Questionnaire (RASQ).<br><br>- The incidence of infusion site extravasations according to CTCAE v5.0.<br><br>- The incidence of infusion related reactions according to CTCAE v5.0.<br><br>- The percentage of HCPs indicating an overall preference for either ICI-B or 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.