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

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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54425

Enrollment

390

Registered

2021-05-18

Start date

2021-10-19

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

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

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
- 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.	—

Measure

Time frame

- 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.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)