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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04146324




Registration number
NCT04146324
Ethics application status
Date submitted
29/10/2019
Date registered
31/10/2019
Date last updated
26/01/2022

Titles & IDs
Public title
An Observational Study of Adjuvant (Post-surgery) Therapy With Nivolumab for Resected (Completely Removed) Melanoma in Australia
Scientific title
A Prospective Observational Study in Patients Receiving Adjuvant Nivolumab Therapy for Resected Melanoma in Australia
Secondary ID [1] 0 0
CA209-7CK
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - nivolumab

Adjuvant nivolumab therapy - Participants receiving nivolumab as an adjuvant therapy according to the market authorization in Australia


Treatment: Drugs: nivolumab
Administered as adjuvant therapy as per the market authorization in Australia
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with Relapse-Free Survival (RFS)
Timepoint [1] 0 0
Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Secondary outcome [1] 0 0
Percentage of Participants with Distant Metastasis-Free Survival (DMFS)
Timepoint [1] 0 0
Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Secondary outcome [3] 0 0
Description of sociodemographic profile of participants
Timepoint [3] 0 0
At treatment initiation with adjuvant nivolumab therapy
Secondary outcome [4] 0 0
Description of clinical characteristics of participants
Timepoint [4] 0 0
At treatment initiation with adjuvant nivolumab therapy
Secondary outcome [5] 0 0
Prior medical history of participants
Timepoint [5] 0 0
At treatment initiation with adjuvant nivolumab therapy
Secondary outcome [6] 0 0
Description of nivolumab pattern of use
Timepoint [6] 0 0
At treatment initiation with adjuvant nivolumab therapy
Secondary outcome [7] 0 0
Health-related quality of life (HRQOL) of participants as assessed by European Quality of Life Five Dimensional Scale (EuroQOL-5D/EQ-5D)
Timepoint [7] 0 0
Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Secondary outcome [8] 0 0
HRQOL of participants as assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ C-30)
Timepoint [8] 0 0
Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Secondary outcome [9] 0 0
HRQOL of participants as assessed by Functional Assessment of Cancer Therapy-Melanoma (FACT-M) questionnaire
Timepoint [9] 0 0
Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Secondary outcome [10] 0 0
Participants' socioeconomic status as assessed by their highest education level
Timepoint [10] 0 0
At treatment initiation with adjuvant nivolumab therapy
Secondary outcome [11] 0 0
Description of care received as assessed by Healthcare Resource Utlization
Timepoint [11] 0 0
During, and up to 5 years post discontinuation of nivolumab use
Secondary outcome [12] 0 0
Number of participants experiencing immune-related Adverse Events (AEs)
Timepoint [12] 0 0
Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Secondary outcome [13] 0 0
Number of participants experiencing non-immune-related AEs
Timepoint [13] 0 0
Up to 5 years post treatment initiation with adjuvant nivolumab therapy

Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com



- 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
9/12/2026
Actual
Sample size
Target
Accrual to date
Final
150
Recruitment in Australia
Recruitment state(s)
ACT,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - Garran
Recruitment hospital [2] 0 0
Local Institution - Birtinya
Recruitment hospital [3] 0 0
Local Institution - Cairns
Recruitment hospital [4] 0 0
Local Institution - Greenslopes
Recruitment hospital [5] 0 0
Local Institution - Herston
Recruitment hospital [6] 0 0
Local Institution - Woolloongabba
Recruitment hospital [7] 0 0
Local Institution - Woodville South
Recruitment hospital [8] 0 0
Local Institution - Box Hill
Recruitment hospital [9] 0 0
Local Institution - Malvern
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
4575 - Birtinya
Recruitment postcode(s) [3] 0 0
4870 - Cairns
Recruitment postcode(s) [4] 0 0
4120 - Greenslopes
Recruitment postcode(s) [5] 0 0
4031 - Herston
Recruitment postcode(s) [6] 0 0
4012 - Woolloongabba
Recruitment postcode(s) [7] 0 0
5001 - Woodville South
Recruitment postcode(s) [8] 0 0
3128 - Box Hill
Recruitment postcode(s) [9] 0 0
3144 - Malvern

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04146324
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04146324