Patient preference for administration of cancer immunotherapy via an elastomeric pump. A patient preference study and an economic analysis.

Phase 1

• Conditions: Solid tumors for which nivolumab or pembrolizumab monotherapy is an EMA approved indication. This includes (but is not limited to) melanoma, renal-cell cancer, NSCLC and head and neck cancer.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-000058-24-NL
• Lead Sponsor: Erasmus MC Cancer Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-18
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

-Age =18 years
-Able and willing to give written informed consent
-Planned treatment with nivolumab or pembrolizumab monotherapy (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 in medical history
-At least 4 remaining cycles of nivolumab or pembrolizumab monotherapy after inclusion in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 312
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 78

Exclusion Criteria

Prior hypersensitivity reactions to nivolumab or pembrolizumab (any grade).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified