Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04146324
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04146324
Recruitment Status : Not yet recruiting
First Posted : October 31, 2019
Last Update Posted : October 31, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date October 29, 2019
First Posted Date October 31, 2019
Last Update Posted Date October 31, 2019
Estimated Study Start Date October 31, 2019
Estimated Primary Completion Date July 9, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 29, 2019)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: October 29, 2019)
  • Percentage of Participants with Distant Metastasis-Free Survival (DMFS) [ Time Frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy ]
  • Overall Survival (OS) [ Time Frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy ]
  • Description of sociodemographic profile of participants [ Time Frame: At treatment initiation with adjuvant nivolumab therapy ]
  • Description of clinical characteristics of participants [ Time Frame: At treatment initiation with adjuvant nivolumab therapy ]
  • Prior medical history of participants [ Time Frame: At treatment initiation with adjuvant nivolumab therapy ]
  • Description of nivolumab pattern of use [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy ]
  • Participants' socioeconomic status as assessed by their highest education level [ Time Frame: At treatment initiation with adjuvant nivolumab therapy ]
  • Description of care received as assessed by Healthcare Resource Utilization [ Time Frame: During, and up to 5 years post discontinuation of nivolumab use ]
  • Number of participants experiencing immune-related Adverse Events (AEs) [ Time Frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy ]
  • Number of participants experiencing non-immune-related AEs [ Time Frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Observational Study of Adjuvant (Post-surgery) Therapy With Nivolumab for Resected (Completely Removed) Melanoma in Australia
Official Title A Prospective Observational Study in Patients Receiving Adjuvant Nivolumab Therapy for Resected Melanoma in Australia
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Melanoma
Intervention Drug: nivolumab
Administered as adjuvant therapy as per the market authorization in Australia
Study Groups/Cohorts Adjuvant nivolumab therapy
Participants receiving nivolumab as an adjuvant therapy according to the market authorization in Australia
Intervention: Drug: nivolumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: October 29, 2019)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 9, 2025
Estimated Primary Completion Date July 9, 2025   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
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 #
Listed Location Countries Australia
Removed Location Countries  
 
Administrative Information
NCT Number NCT04146324
Other Study ID Numbers CA209-7CK
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor Bristol-Myers Squibb
Collaborators Not Provided
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date October 2019