MelanomaNICONCT02990611
Observational Study of Nivolumab Monotherapy or in Combination With Ipilimumab in Participants With Advanced Melanoma and in Participants With Adjuvant Nivolumab Therapy
An observational study of Melanoma, run by Bristol-Myers Squibb at 1 site in Germany.
Trial summary
The purpose of this study is to describe the safety and effectiveness of nivolumab treatment, either in monotherapy or in combination with ipilimumab, overall and according to various subgroups of interest, in participants with advanced melanoma and in participants with adjuvant nivolumab therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- How many people
- 1,087 participants
- Where
- 1 siteGermany
- Study dates
- 6 Dec 2016to 20 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Adult participants who are at least 18 years of age of the time of treatment decision with a primary diagnosis of advanced melanoma (histologically confirmed Stage III [unresectable] or Stage IV skin, ocular, or mucosal melanoma) and whose physician has already decided to initiate a treatment with nivolumab or nivolumab/ipilimumab for the first time for the treatment of melanoma, according to the label approved in Germany. Participants with a current primary diagnosis of a cancer other than advanced melanoma, participants currently included in an interventional clinical trial, or participants who have already received nivolumab in a prior line of therapy (for monotherapy arm) will all be excluded from this study. Adult participants in the adjuvant nivolumab treatment cohort will be enrolled after complete surgical resection and no evidence of disease after the treating physician has decided to initiate an adjuvant therapy with nivolumab according to the label approved in Germany.
Who may be able to join
- For Cohort 1 and 2: (Recruitment ended by 02/20/2020)
- Advanced melanoma (Stage III/Stage IV)
- Histologically confirmed diagnosis
- Treatment decision for nivolumab monotherapy or nivolumab/ipilimumab combination therapy has already been taken
- For Cohort 3: (Recruitment ended by 08/31/2020)
- Primary diagnosis of advanced melanoma after complete surgical tumor resection and no evidence of disease
- Treatment decision for adjuvant nivolumab therapy has already been taken
Who cannot join
- For Cohort 1 and 2: (Recruitment ended by 02/20/2020)
- Current primary diagnosis of a cancer other than advanced melanoma, that requires systemic or other treatment or has not been treated curatively (as per discretion of the investigator)
- Previous treatment with nivolumab, for nivolumab monotherapy cohort only
- Current active participation in an interventional clinical trial
- For Cohort 3: (Recruitment ended by 08/31/2020)
- Current diagnosis of persisting advanced melanoma or a cancer other than advanced melanoma that requires systemic or other treatment or has not been treated curatively (as per discretion of the investigator)
- Current active participation in an interventional clinical trial
- 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) of Nivolumab (BMS-936558) Monotherapy or in Combination With Ipilimumab in Patients With Advanced (Unresectable or Metastatic) Melanoma and in Patients With Adjuvant Nivolumab Therapy
The purpose of this study is to describe the safety and effectiveness of nivolumab treatment, either in monotherapy or in combination with ipilimumab, overall and according to various subgroups of interest, in participants with advanced melanoma and in participants with adjuvant nivolumab therapy.
- 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 |
|---|---|---|
| Cohort 1: Nivolumab/Ipilimumab combination therapy | Participants who start a new systemic therapy with nivolumab/ipilimumab combination therapy for the first time | |
| Cohort 2: Nivolumab monotherapy | Participants who start a new systemic therapy with nivolumab monotherapy for the first time | |
| Cohort 3: Nivolumab adjuvant therapy | Participants who start adjuvant treatment with nivolumab after complete surgical tumor resection and no evidence of disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS) of nivolumab/ipilimumab combination therapy
Measured: 5 years
Relapse free survival (RFS) of adjuvant nivolumab therapy
Measured: 5 years
Secondary outcomes (31)
Overall survival (OS) of nivolumab monotherapy
Measured: 5 years
Overall survival (OS) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy, according to other subgroups of interest
Measured: 5 years
Progression-free survival (PFS) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy
Measured: 5 years
Overall response rate (ORR) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy
Measured: 5 years
Best overall response (BOR) of nivolumab monotherapy and of nivolumab/ipilimumab combination therapy
Measured: 5 years
Best overall response rate (BORR) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy
Measured: 5 years
Duration of response of monotherapy and combination therapy
Measured: Up to 5 years
Distribution of sociodemographic characteristics: Age
Measured: 5 years
Distribution of sociodemographic characteristics: Gender
Measured: 5 years
Distribution of sociodemographic characteristics: BMI
Measured: 5 years
Distribution of clinical characteristics: Initial diagnosis of melanoma
Measured: 5 years
Distribution of clinical characteristics: Diagnosis of advanced melanoma
Measured: 5 years
Distribution of clinical characteristics: Duration of disease from date of initial melanoma diagnosis to initial treatment in study, or date of study entry (if untreated)
Measured: 5 years
Distribution of clinical characteristics: Surgery of complete tumor resection and no evidence of disease
Measured: 5 years
Distribution of clinical characteristics: Clinical code and staging melanoma subtypes
Measured: 5 years
Distribution of clinical characteristics: Comorbidities
Measured: 5 years
Distribution of clinical characteristics: Diagnostic procedures
Measured: 5 years
Distribution of clinical characteristics: Mutation status
Measured: 5 years
Distribution of clinical characteristics: Performance status as measured by Eastern Cancer Oncology Group (ECOG) scale
Measured: 5 years
Distribution of clinical characteristics: Medical history
Measured: 5 years
Distribution of clinical characteristics: Concomitant medication
Measured: 5 years
Distribution of clinical characteristics: History of cancer
Measured: 5 years
Distribution of clinical characteristics: Previous enrollment in an interventional study randomized controlled trials (RCTS)
Measured: 5 years
Distribution of treatment patterns: Type of treatment previously received
Measured: 5 years
Distribution of treatment patterns: Stage of melanoma
Measured: 5 years
Distribution of treatment patterns: Current treatment details
Measured: 5 years
European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ C-30)
Measured: 5 years
Incidence of adverse events (AEs)
Measured: 5 years
Severity of adverse events (AEs)
Measured: 5 years
Distribution of management of adverse events (AEs)
Measured: 5 years
Overall survival (OS) of adjuvant therapy
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study start6 Dec 2016
- Primary completion20 Jun 2025
- Study completion20 Jun 2025
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
- 1,087 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
- NCT02990611
- Sponsor's protocol ID
- CA209-654
- Acronym
- NICO
- Status last verified
- Jul 2025
- First submitted
- 2 Dec 2016
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Gutzmer R, Weichenthal M, Eigentler T, Mohr P, Sickmann T, Ducker P, Gebhardt C, Haferkamp S, Kahler KC, Meier F, Pfohler C, Sindrilaru A, Terheyden P, von Wasielewski I, Ugurel S, Ulrich J, Utikal J, Weishaupt C, Schadendorf D. Real-world effectiveness and safety with nivolumab plus ipilimumab or nivolumab alone in patients with or without melanoma brain metastasis: Results from the German noninterventional NICO study. Int J Cancer. 2026 Aug 1;159(3):683-698. doi: 10.1002/ijc.70440. Epub 2026 Mar 15.
PubMed 41833546
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National, Prospective, Non-Interventional Study (NIS) of Nivolumab (BMS-936558) Monotherapy or in Combination With Ipilimumab in Patients With Advanced (Unresectable or Metastatic) Melanoma and in Patients With Adjuvant Nivolumab Therapy
- ClinicalTrials.gov ID
- NCT02990611
- Acronym / sponsor ID
- NICO / CA209-654
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,087 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2016 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 13 Dec 2016 (estimated)
- 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.
The purpose of this study is to describe the safety and effectiveness of nivolumab treatment, either in monotherapy or in combination with ipilimumab, overall and according to various subgroups of interest, in participants with advanced melanoma and in participants with adjuvant nivolumab therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Nivolumab/Ipilimumab combination therapy | – | –Participants who start a new systemic therapy with nivolumab/ipilimumab combination therapy for the first time |
| Cohort 2: Nivolumab monotherapy | – | –Participants who start a new systemic therapy with nivolumab monotherapy for the first time |
| Cohort 3: Nivolumab adjuvant therapy | – | –Participants who start adjuvant treatment with nivolumab after complete surgical tumor resection and no evidence of disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants who are at least 18 years of age of the time of treatment decision with a primary diagnosis of advanced melanoma (histologically confirmed Stage III [unresectable] or Stage IV skin, ocular, or mucosal melanoma) and whose physician has already decided to initiate a treatment with nivolumab or nivolumab/ipilimumab for the first time for the treatment of melanoma, according to the label approved in Germany. Participants with a current primary diagnosis of a cancer other than advanced melanoma, participants currently included in an interventional clinical trial, or participants who have already received nivolumab in a prior line of therapy (for monotherapy arm) will all be excluded from this study. Adult participants in the adjuvant nivolumab treatment cohort will be enrolled after complete surgical resection and no evidence of disease after the treating physician has decided to initiate an adjuvant therapy with nivolumab according to the label approved in Germany.
Key inclusion criteria (7 listed)
- For Cohort 1 and 2: (Recruitment ended by 02/20/2020)
- Advanced melanoma (Stage III/Stage IV)
- Histologically confirmed diagnosis
- Treatment decision for nivolumab monotherapy or nivolumab/ipilimumab combination therapy has already been taken
- For Cohort 3: (Recruitment ended by 08/31/2020)
Key exclusion criteria (8 listed)
- For Cohort 1 and 2: (Recruitment ended by 02/20/2020)
- Current primary diagnosis of a cancer other than advanced melanoma, that requires systemic or other treatment or has not been treated curatively (as per discretion of the investigator)
- Previous treatment with nivolumab, for nivolumab monotherapy cohort only
- Current active participation in an interventional clinical trial
- For Cohort 3: (Recruitment ended by 08/31/2020)
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
Overall survival (OS) of nivolumab/ipilimumab combination therapy
Time frame: 5 years
Relapse free survival (RFS) of adjuvant nivolumab therapy
Time frame: 5 years
31 secondary outcomes
Overall survival (OS) of nivolumab monotherapy
Time frame: 5 years
Overall survival (OS) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy, according to other subgroups of interest
Time frame: 5 years
Progression-free survival (PFS) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy
Time frame: 5 years
Overall response rate (ORR) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy
Time frame: 5 years
Best overall response (BOR) of nivolumab monotherapy and of nivolumab/ipilimumab combination therapy
Time frame: 5 years
Best overall response rate (BORR) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy
Time frame: 5 years
Duration of response of monotherapy and combination therapy
Time frame: Up to 5 years
Distribution of sociodemographic characteristics: Age
Time frame: 5 years
Distribution of sociodemographic characteristics: Gender
Time frame: 5 years
Distribution of sociodemographic characteristics: BMI
Time frame: 5 years
Distribution of clinical characteristics: Initial diagnosis of melanoma
Time frame: 5 years
Distribution of clinical characteristics: Diagnosis of advanced melanoma
Time frame: 5 years
Distribution of clinical characteristics: Duration of disease from date of initial melanoma diagnosis to initial treatment in study, or date of study entry (if untreated)
Time frame: 5 years
Distribution of clinical characteristics: Surgery of complete tumor resection and no evidence of disease
Time frame: 5 years
Distribution of clinical characteristics: Clinical code and staging melanoma subtypes
Time frame: 5 years
Distribution of clinical characteristics: Comorbidities
Time frame: 5 years
Distribution of clinical characteristics: Diagnostic procedures
Time frame: 5 years
Distribution of clinical characteristics: Mutation status
Time frame: 5 years
Distribution of clinical characteristics: Performance status as measured by Eastern Cancer Oncology Group (ECOG) scale
Time frame: 5 years
Distribution of clinical characteristics: Medical history
Time frame: 5 years
Distribution of clinical characteristics: Concomitant medication
Time frame: 5 years
Distribution of clinical characteristics: History of cancer
Time frame: 5 years
Distribution of clinical characteristics: Previous enrollment in an interventional study randomized controlled trials (RCTS)
Time frame: 5 years
Distribution of treatment patterns: Type of treatment previously received
Time frame: 5 years
Distribution of treatment patterns: Stage of melanoma
Time frame: 5 years
Distribution of treatment patterns: Current treatment details
Time frame: 5 years
European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ C-30)
Time frame: 5 years
Incidence of adverse events (AEs)
Time frame: 5 years
Severity of adverse events (AEs)
Time frame: 5 years
Distribution of management of adverse events (AEs)
Time frame: 5 years
Overall survival (OS) of adjuvant therapy
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Derived from this study: PubMed 41833546Gutzmer R, Weichenthal M, Eigentler T, Mohr P, Sickmann T, Ducker P, Gebhardt C, Haferkamp S, Kahler KC, Meier F, Pfohler C, Sindrilaru A, Terheyden P, von Wasielewski I, Ugurel S, Ulrich J, Utikal J, Weishaupt C, Schadendorf D. Real-world effectiveness and safety with nivolumab plus ipilimumab or nivolumab alone in patients with or without melanoma brain metastasis: Results from the German noninterventional NICO study. Int J Cancer. 2026 Aug 1;159(3):683-698. doi: 10.1002/ijc.70440. Epub 2026 Mar 15.
- BMS Clinical Trial InformationLink 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 Germany.
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 7 inclusion and 8 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: finished, as of the sponsor's last update on 11 Jul 2025. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall survival (OS) of nivolumab/ipilimumab combination therapy (time frame: 5 years). The study lists 2 primary outcomes in all. 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 NCT02990611, 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 11 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.