Clinical trial · Observational
An Observational Study of Adjuvant (Post-surgery) Therapy With Nivolumab for Resected (Completely Removed) Melanoma in Australia
A Prospective Observational Study in Patients Receiving Adjuvant Nivolumab Therapy for Resected Melanoma in Australia
NCT04146324CI-TRIAL-00085085completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is designed to estimate the effectiveness of nivolumab when given to participants after removing their cancer with surgery, over a 5-year follow-up, in real-world conditions in Australia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Adjuvant nivolumab therapy
- description
- Participants receiving nivolumab as an adjuvant therapy according to the market authorization in Australia
- interventionNames
- Drug: nivolumab
Primary outcomes (1)
- measure
- Percentage of Participants with Relapse-Free Survival (RFS)
- timeFrame
- Up to 5 years post treatment initiation with adjuvant nivolumab therapy
- description
- The time between the date of randomisation and the date of first recurrence, new primary melanoma, or death due to any cause, whichever occurred first.
Secondary outcomes (13)
- measure
- Percentage of Participants with Distant Metastasis-Free Survival (DMFS)
- timeFrame
- Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Adults with a primary diagnosis of melanoma with involvement of lymph nodes or metastatic disease who have undergone complete surgical removal and have no evidence of disease * Decision to treat with adjuvant nivolumab therapy has already been taken * Ability to provide written informed consent to participate in the study Exclusion Criteria: * Adults with a current diagnosis of persisting advanced melanoma * Adults currently enrolled in an interventional clinical trial for his/her melanoma treatment Other protocol-defined inclusion/exclusion criteria apply
References
Publications (0)
Data not yet available
No reference posted for this study.