Melanoma
Conditions
Keywords
Adjuvant, nivolumab
Brief summary
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.
Interventions
DRUGnivolumab
Administered as adjuvant therapy as per the market authorization in Australia
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with Relapse-Free Survival (RFS) | Up to 5 years post treatment initiation with adjuvant nivolumab therapy | 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
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | Up to 5 years post treatment initiation with adjuvant nivolumab therapy |
| Description of sociodemographic profile of participants | At treatment initiation with adjuvant nivolumab therapy |
| Description of clinical characteristics of participants | At treatment initiation with adjuvant nivolumab therapy |
| Prior medical history of participants | At treatment initiation with adjuvant nivolumab therapy |
| Description of nivolumab pattern of use | At treatment initiation with adjuvant nivolumab therapy |
| Health-related quality of life (HRQOL) of participants as assessed by European Quality of Life Five Dimensional Scale (EuroQOL-5D/EQ-5D) | Up to 5 years post treatment initiation with adjuvant nivolumab therapy |
| Percentage of Participants with Distant Metastasis-Free Survival (DMFS) | Up to 5 years post treatment initiation with adjuvant nivolumab therapy |
| HRQOL of participants as assessed by Functional Assessment of Cancer Therapy-Melanoma (FACT-M) questionnaire | Up to 5 years post treatment initiation with adjuvant nivolumab therapy |
| Participants' socioeconomic status as assessed by their highest education level | At treatment initiation with adjuvant nivolumab therapy |
| Description of care received as assessed by Healthcare Resource Utlization | During, and up to 5 years post discontinuation of nivolumab use |
| Number of participants experiencing immune-related Adverse Events (AEs) | Up to 5 years post treatment initiation with adjuvant nivolumab therapy |
| Number of participants experiencing non-immune-related AEs | Up to 5 years post treatment initiation with adjuvant nivolumab therapy |
| HRQOL of participants as assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ C-30) | Up to 5 years post treatment initiation with adjuvant nivolumab therapy |
Countries
Australia
Outcome results
None listed