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Active, not recruitingNCT04550247AdjuMelUpdated Mar 21, 2022

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

An observational study in Melanoma, sponsored by Bristol-Myers Squibb. Active, not recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-21.

Sponsored by Bristol-Myers Squibb · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
362
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Melanoma

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03

In context

Melanoma

3,073 studies on the registry are indexed under Melanoma; 529 are open to participants now.

This study's enrollment of 362 is above the median of 182 across 448 observational studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,562 studies on the registry; 118 are open to participants now.

Of its 435 completed or terminated interventional studies of FDA-regulated products, 227 (52%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study will collect data primarily from hospital based dermatology and oncology care facilities

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Inclusion criteria

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

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

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
362 participants (actual)
Patient registry
No

Groups and cohorts

  • Nivolumab treatment

    Administered according to the market authorization in France

06

What researchers measure

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

07

Study locations

1 site
  • Local Institution
    Lille, 59000, France
08

References and documents

Publications

  • Dalle S, Saiag P, Lebbe C, Grob JJ, Dreno B, Dalac S, Asselain B, Skowron F, Darras S, Jovenin N, Quereux G, Khammari A, Rieuf C, Brellier F, Mortier L. Real-World Use of Adjuvant Nivolumab for Resected Stage III-IV Melanoma: 2-Year Analysis of AdjuMel. Dermatol Ther (Heidelb). 2026 Aug 29. doi: 10.1007/s13555-026-01853-4. Online ahead of print. PubMed 42667537 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04550247
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Sep 16, 2020
Start date
Sep 2, 2020
Primary completion
Mar 15, 2027 (estimated)
Completion
Mar 15, 2027 (estimated)
Last update
Mar 21, 2022

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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