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Clinical Trials/EUCTR2021-000058-24-NL
EUCTR2021-000058-24-NL
Active, not recruiting
Phase 1

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

Erasmus MC Cancer Institute0 sites390 target enrollmentMay 18, 2021
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ConditionsSolid 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]
DrugsOpdivoKeytruda

Overview

Phase
Phase 1
Intervention
Not specified
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.
Sponsor
Erasmus MC Cancer Institute
Enrollment
390
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 18, 2021
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Erasmus MC Cancer Institute

Eligibility Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Not specified

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