Clinical trial · Observational
A Study of Patients Receiving Adjuvant Nivolumab Therapy for Melanoma That Has Been Removed
An Observational Study in Patients Receiving Adjuvant Nivolumab Therapy for Resected Melanoma
NCT03771859CI-TRIAL-00113334completedClinicalTrials.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)
An observational study of melanoma participants who are eligible for and who have initiated treatment with adjuvant nivolumab as part of routine clinical practice.
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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Participants who initiate adjuvant treatment with nivolumab
Primary outcomes (1)
- measure
- RFS (relapse free survival)
- timeFrame
- 5 years
Secondary outcomes (10)
- measure
- DMFS (distant metastasis free survival)
- timeFrame
- 5 years
- measure
- OS (overall survival)
- timeFrame
- 5 years
- measure
- Distribution of sociodemographic characteristics in participants initiating nivolumab
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a primary diagnosis of melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection and have no evidence of disease. * Decision to treat with adjuvant nivolumab therapy has already been taken * At least 18 years of age at the time of treatment decision * Patients who provide written informed consent to participate in the study (for retrospectively enrolled patients who are deceased at time of study start, a consent waiver will be sought) Exclusion Criteria: * Any patient with a diagnosis of persisting advanced melanoma prior to first administration of nivolumab * Any patient currently enrolled in an interventional clinical trial for his/her melanoma treatment (note: patients who have completed their participation in an interventional trial or who are no longer receiving the study drug and are only followed up for Overall Survival (OS)/ Relapse Free Survival (RFS) can be enrolled. In case of a blinded study, the treatment arm needs to be known). Other protocol defined inclusion/exclusion criteria could apply
References
Publications (0)
Data not yet available
No reference posted for this study.