At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 14 enrolled
Drug / intervention
Nivolumab/rHuPH20 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Open Label, Randomized, Non-Inferiority Pharmacokinetic Study of Nivolumab Subcutaneous (Nivo SC) Versus Intravenous (Nivo IV) Administration in Participants With Stage IIIA/B/C/D or Stage IV Adjuvant Melanoma Following Complete Resection
In Brief
A Phase 3 clinical trial evaluating Nivolumab/rHuPH20 and Nivolumab for Melanoma. Completed, enrolled 14 participants across 16 sites in 7 countries.
Detailed Summary
The purpose of this study is to assess the safety and tolerability of subcutaneous nivolumab vs intravenous nivolumab in participants with completely resected Stage IIIA/B/C/D or Stage IV melanoma.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesAustralia, Belgium, Italy, Poland, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2023202420252026
First PostedMar 2022
Enrollment StartAug 2022
Primary CompletionFeb 2024
TodayJul 2026
First PostedMar 28, 2022
Enrollment StartAug 2, 2022
Primary CompletionFeb 8, 2024
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 4.3 years ago
Interventions
Nivolumab/rHuPH20biological
Specified dose on specified days
Nivolumabbiological
Specified dose on specified days