MelanomaAdjuMelNCT04550247
A Prospective Non-Interventional Study in Participants Receiving Nivolumab in Adjuvant Setting for Resected Melanoma in Real-World Conditions in France
An observational study of Melanoma, run by Bristol-Myers Squibb at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- How many people
- 362 participants
- Where
- 1 siteFrance
- Study dates
- 2 Sep 2020to 15 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will collect data primarily from hospital based dermatology and oncology care facilities
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A National, Prospective, Non- Interventional Study (NIS) in Patients Receiving Adjuvant Nivolumab Therapy for Resected Melanoma and Subsequent Treatments in Case of Relapse
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.
- Conditions
- Melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab treatment | Administered according to the market authorization in France |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-Free Survival (RFS)
Measured: up to 60 months
Secondary outcomes (30)
Distant Metastatasis-Free Survival (DMFS)
Measured: Up to 60 months
Overall Survival (OS)
Measured: Up to 60 months
Relapse-Free Survival 2 (RFS2)
Measured: Up to 60 months
Progression Free Survival (PFS)
Measured: Up to 60 months
Assessment of health related quality of life
Measured: Up to 60 Months
Assessment of sociodemographic characteristics
Measured: Up to 60 months
Assessment of clinical characteristics
Measured: Up to 60 months
Frequency of nivolumab therapy: number of infusions
Measured: Up to 60 months
Frequency of nivolumab therapy: number of dosing
Measured: Up to 60 months
Frequency of Nivolumab: pattern of use
Measured: Up to 60 months
Characteristics of nivolumab adjuvant safety profile: incidence
Measured: Up to 60 months
Characteristics of nivolumab adjuvant safety profile: grade
Measured: Up to 60 months
Characteristics of nivolumab adjuvant safety profile: type
Measured: Up to 60 months
Characteristics of nivolumab adjuvant safety profile: time to onset of select AEs
Measured: Up to 60 months
Characteristics of nivolumab adjuvant safety profile: time to onset of other immune- related AEs
Measured: Up to 60 months
Characteristics of nivolumab adjuvant safety profile: time to resolution of select AEs
Measured: Up to 60 months
Characteristics of nivolumab adjuvant safety profile: time to resolution of other immune-related AEs
Measured: Up to 60 months
Describe the use of subsequent therapies after relapse following adjuvant nivolumab
Measured: Up to 60 months
Estimate of the effectiveness of systemic therapies administered after relapse following adjuvant nivolumab, in terms of time and duration of response
Measured: Up to 60 months
Estimate of the effectiveness of systemic therapies administered after relapse following adjuvant nivolumab, in terms of overall response rate
Measured: Up to 60 months
Safety profile of systemic therapies administered after relapse in terms of severe adverse events incidence, type, management and outcome
Measured: Up to 60 months
Estimate the effectiveness of subsequents treatments administered after relapse in terms of PFS
Measured: Up to 60 months
Estimate the effectiveness of subsequents treatments administered after relapse in terms of RFS2
Measured: Up to 60 months
Estimate the effectiveness of subsequents treatments administered after relapse in terms of OS
Measured: Up to 60 months
Characteristics of nivolumab adjuvant safety profile: management
Measured: Up to 60 months
Characteristics of nivolumab adjuvant safety profile: outcome
Measured: Up to 60 months
Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Incidence
Measured: Up to 60 months
Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Type
Measured: Up to 60 months
Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Management
Measured: Up to 60 months
Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Outcome
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start2 Sep 2020
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550247
- Sponsor's protocol ID
- CA209-7HU
- Acronym
- AdjuMel
- Status last verified
- Mar 2022
- First submitted
- 9 Sep 2020
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National, Prospective, Non- Interventional Study (NIS) in Patients Receiving Adjuvant Nivolumab Therapy for Resected Melanoma and Subsequent Treatments in Case of Relapse
- ClinicalTrials.gov ID
- NCT04550247
- Acronym / sponsor ID
- AdjuMel / CA209-7HU
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nivolumab treatment | – | –Administered according to the market authorization in France |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will collect data primarily from hospital based dermatology and oncology care facilities
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relapse-Free Survival (RFS)
Time frame: up to 60 months
30 secondary outcomes
Distant Metastatasis-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 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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Derived from this study: PubMed 42667537Dalle 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.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by Bristol-Myers Squibb at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse-Free Survival (RFS) (time frame: up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04550247, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022.