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NCT Number: NCT04550247

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Relapse-Free Survival (RFS)

    Time frame: up to 60 months

Secondary outcomes

  1. Distant Metastatasis-Free Survival (DMFS)

    Time frame: Up to 60 months

  2. Overall Survival (OS)

    Time frame: Up to 60 months

  3. Relapse-Free Survival 2 (RFS2)

    Time frame: Up to 60 months

  4. Progression Free Survival (PFS)

    Time frame: Up to 60 months

  5. Assessment of health related quality of life

    Time frame: Up to 60 Months

  6. Assessment of sociodemographic characteristics

    Time frame: Up to 60 months

  7. Assessment of clinical characteristics

    Time frame: Up to 60 months

  8. Frequency of nivolumab therapy: number of infusions

    Time frame: Up to 60 months

  9. Frequency of nivolumab therapy: number of dosing

    Time frame: Up to 60 months

  10. Frequency of Nivolumab: pattern of use

    Time frame: Up to 60 months

  11. Characteristics of nivolumab adjuvant safety profile: incidence

    Time frame: Up to 60 months

  12. Characteristics of nivolumab adjuvant safety profile: grade

    Time frame: Up to 60 months

  13. Characteristics of nivolumab adjuvant safety profile: type

    Time frame: Up to 60 months

  14. Characteristics of nivolumab adjuvant safety profile: time to onset of select AEs

    Time frame: Up to 60 months

  15. Characteristics of nivolumab adjuvant safety profile: time to onset of other immune- related AEs

    Time frame: Up to 60 months

  16. Characteristics of nivolumab adjuvant safety profile: time to resolution of select AEs

    Time frame: Up to 60 months

  17. Characteristics of nivolumab adjuvant safety profile: time to resolution of other immune-related AEs

    Time frame: Up to 60 months

  18. Describe the use of subsequent therapies after relapse following adjuvant nivolumab

    Time frame: Up to 60 months

  19. Estimate of 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

  20. Estimate of the effectiveness of systemic therapies administered after relapse following adjuvant nivolumab, in terms of overall response rate

    Time frame: Up to 60 months

  21. 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

  22. Estimate the effectiveness of subsequents treatments administered after relapse in terms of PFS

    Time frame: Up to 60 months

  23. Estimate the effectiveness of subsequents treatments administered after relapse in terms of RFS2

    Time frame: Up to 60 months

  24. Estimate the effectiveness of subsequents treatments administered after relapse in terms of OS

    Time frame: Up to 60 months

  25. Characteristics of nivolumab adjuvant safety profile: management

    Time frame: Up to 60 months

  26. Characteristics of nivolumab adjuvant safety profile: outcome

    Time frame: Up to 60 months

  27. Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Incidence

    Time frame: Up to 60 months

  28. Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Type

    Time frame: Up to 60 months

  29. Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Management

    Time frame: Up to 60 months

  30. Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Outcome

    Time frame: Up to 60 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Acronym: AdjuMel

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Sep 16, 2020
Registry last updated
Mar 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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