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An Observational Study of Adjuvant (Post-surgery) Therapy With Nivolumab for Resected (Completely Removed) Melanoma in Australia

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ClinicalTrials.gov Identifier: NCT04146324
Recruitment Status : Recruiting
First Posted : October 31, 2019
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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.

Condition or disease Intervention/treatment
Melanoma Drug: nivolumab

Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study in Patients Receiving Adjuvant Nivolumab Therapy for Resected Melanoma in Australia
Actual Study Start Date : October 24, 2019
Estimated Primary Completion Date : July 9, 2025
Estimated Study Completion Date : July 9, 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma
Drug Information available for: Nivolumab

Groups and Cohorts
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Group/Cohort Intervention/treatment
Adjuvant nivolumab therapy
Participants receiving nivolumab as an adjuvant therapy according to the market authorization in Australia
 Drug: nivolumab
Administered as adjuvant therapy as per the market authorization in Australia


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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults whose melanoma had spread to the lymph nodes or other parts of the body and was surgically removed, and who are receiving post-surgery treatment with nivolumab to decrease the risk of cancer coming back.
Criteria

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 Inclusion/Exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04146324


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #

Locations
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Australia, Australian Capital Territory
Local Institution Not yet recruiting
Garran, Australian Capital Territory, Australia, 2605
Contact: Site 0004         
Australia, Queensland
Local Institution Recruiting
Birtinya, Queensland, Australia, 4575
Contact: Site 0011         
Local Institution Recruiting
Cairns, Queensland, Australia, 4870
Contact: Site 0010         
Local Institution Recruiting
Greenslopes, Queensland, Australia, 4120
Contact: Site 0001         
Local Institution Recruiting
Herston, Queensland, Australia, 4031
Contact: Site 0008         
Local Institution Recruiting
Woolloongabba, Queensland, Australia, 4012
Contact: Site 0005         
Australia, South Australia
Local Institution Withdrawn
Adelaide, South Australia, Australia, 5000
Local Institution Recruiting
Woodville South, South Australia, Australia, 5001
Contact: Site 0006         
Australia, Victoria
Local Institution Recruiting
Box Hill, Victoria, Australia, 3128
Contact: Site 0002         
Local Institution Recruiting
Malvern, Victoria, Australia, 3144
Contact: Site 0003         
Local Institution Withdrawn
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04146324    
Other Study ID Numbers: CA209-7CK
First Posted: October 31, 2019    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
Adjuvant
nivolumab
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Nerve Tissue
Nevi and Melanomas
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents