A Prospective Non-Interventional Study in Participants Receiving Nivolumab in Adjuvant Setting for Resected Melanoma in Real-World Conditions in France

Overview

This is an observational prospective study to estimate in real world conditions the effectiveness, the safety profile and the pattern of use of adjuvant nivolumab in adults participants with stage III/IV resected melanoma, and subsequent treatments administered in case of relapse.

Full Title of Study: “A National, Prospective, Non- Interventional Study (NIS) in Patients Receiving Adjuvant Nivolumab Therapy for Resected Melanoma and Subsequent Treatments in Case of Relapse”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 15, 2027

Arms, Groups and Cohorts

  • Nivolumab treatment
    • Administered according to the market authorization in France

Clinical Trial Outcome Measures

Primary Measures

  • Relapse-Free Survival (RFS)
    • Time Frame: up to 60 months

Secondary Measures

  • Distant Metastasis-Free Survival (DMFS)
    • Time Frame: Up to 60 months
  • Overall Survival (OS)
    • Time Frame: Up to 60 months
  • Relapse-Free Survival 2 (RFS2)
    • Time Frame: Up to 60 months
  • Progression Free Survival (PFS)
    • Time Frame: Up to 60 months
  • Assessment of health related quality of life
    • Time Frame: Up to 60 Months
  • Assessment of sociodemographic characteristics
    • Time Frame: Up to 60 months
  • Assessment of clinical characteristics
    • Time Frame: Up to 60 months
  • Frequency of nivolumab therapy: number of infusions
    • Time Frame: Up to 60 months
  • Frequency of nivolumab therapy: number of dosing
    • Time Frame: Up to 60 months
  • Frequency of Nivolumab: pattern of use
    • Time Frame: Up to 60 months
  • Characteristics of nivolumab adjuvant safety profile: incidence
    • Time Frame: Up to 60 months
  • Characteristics of nivolumab adjuvant safety profile: grade
    • Time Frame: Up to 60 months
  • Characteristics of nivolumab adjuvant safety profile: type
    • Time Frame: Up to 60 months
  • Characteristics of nivolumab adjuvant safety profile: time to onset of select AEs
    • Time Frame: Up to 60 months
  • Characteristics of nivolumab adjuvant safety profile: time to onset of other immune- related AEs
    • Time Frame: Up to 60 months
  • Characteristics of nivolumab adjuvant safety profile: time to resolution of select AEs
    • Time Frame: Up to 60 months
  • Characteristics of nivolumab adjuvant safety profile: time to resolution of other immune-related AEs
    • Time Frame: Up to 60 months
  • Describe the use of subsequent therapies after relapse following adjuvant nivolumab
    • Time Frame: Up to 60 months
  • Estimate the effectiveness of systemic therapies administered after relapse following adjuvant nivolumab, in terms of time and duration of response
    • Time Frame: Up to 60 months
  • Estimate the effectiveness of systemic therapies administered after relapse following adjuvant nivolumab, in terms of overall response rate
    • Time Frame: Up to 60 months
  • Safety profile of systemic therapies administered after relapse in terms of severe adverse events incidence, type, management and outcome
    • Time Frame: Up to 60 months
  • Estimate the effectiveness of subsequents treatments administered after relapse in terms of PFS
    • Time Frame: Up to 60 months
  • Estimate the effectiveness of subsequents treatments administered after relapse in terms of RFS2
    • Time Frame: Up to 60 months
  • Estimate the effectiveness of subsequents treatments administered after relapse in terms of OS
    • Time Frame: Up to 60 months
  • Characteristics of nivolumab adjuvant safety profile: management
    • Time Frame: Up to 60 months
  • Characteristics of nivolumab adjuvant safety profile: outcome
    • Time Frame: Up to 60 months
  • Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Incidence
    • Time Frame: Up to 60 months
  • Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Type
    • Time Frame: Up to 60 months
  • Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Management
    • Time Frame: Up to 60 months
  • Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Outcome
    • Time Frame: Up to 60 months

Participating in This Clinical Trial

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

Inclusion Criteria

  • Participants 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
  • Participants who provide oral informed consent to participate in the study

Exclusion Criteria

  • Any participant with a current diagnosis of persisting advanced melanoma
  • Participants with a current primary diagnosis of a cancer other than advanced melanoma, ie, a cancer other than melanoma that requires systemic or other treatment or has not been treated curatively (as per discretion of the investigator)
  • Any participants 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 OS/RFS can be enrolled. In case of a blinded study, the treatment arm needs to be known).
  • Pregnant women
  • Person under guardianship

Other protocol defined inclusion/exclusion criteria apply

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bristol-Myers Squibb
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb
  • Overall Contact(s)
    • Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,, please email:, Clinical.Trials@bms.com

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