MelanomaNCT06163170
A Study to Evaluate Treatment With Nivolumab Alone and Nivolumab Combined With Ipilimumab in Children With Melanoma
An observational study of Melanoma, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to describe real-world safety outcomes in children with melanoma who are treated with nivolumab alone or nivolumab in combination with ipilimumab for unresectable or metastatic melanoma, or treated with adjuvant nivolumab after resection of stage IIB-IV melanoma. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Melanoma
- What is being tested?
- Nivolumab +/- ipilimumab and Nivolumab
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2023to 10 Nov 2023
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric participants (<18 years of age) who were treated with nivolumab monotherapy or nivolumab combined with ipilimumab for unresectable or metastatic melanoma or treated with adjuvant nivolumab after resection of stage IIb-IV melanoma
Who may be able to join
- Participants with confirmed diagnosis of unresectable or metastatic cutaneous melanoma, or stage IIB-IV cutaneous melanoma who have undergone complete resection
- Initiated treatment with nivolumab monotherapy or in combination with ipilimumab for unresectable or metastatic melanoma, or as adjuvant therapy for resected stage IIb-IV melanoma, between January 1, 2015 and 6 months prior to data collection
- For the adjuvant nivolumab cohort, initiated treatment with nivolumab for stage IIb-IV melanoma within 12 weeks following index resection
- Aged <18 years at the time of nivolumab/ipilimumab treatment initiation
- At least 6 months of follow-up from index treatment date (unless deceased prior to end of 6 months)
Who cannot join
- Prior malignancy active within 3 years prior to nivolumab or ipilimumab treatment index date except for locally curable cancers that have been apparently cured (such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast)
- Receiving nivolumab therapy (monotherapy, combination with ipilimumab, or adjuvant therapy) for melanoma as part of a clinical trial during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-World Evaluation of Patient Characteristics, Treatment Patterns, Safety, and Efficacy of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab for Pediatric Melanoma
The purpose of this study is to describe real-world safety outcomes in children with melanoma who are treated with nivolumab alone or nivolumab in combination with ipilimumab for unresectable or metastatic melanoma, or treated with adjuvant nivolumab after resection of stage IIB-IV melanoma. Demographic and clinical characteristics, and treatment patterns, will also be described in this population.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab +/- ipilimumabDrug
Participants treated with nivolumab +/- ipilimumab for unresectable/metastatic melanoma
NivolumabDrug
Participants treated with nivolumab as adjuvant therapy for resected stage IIB-IV melanoma
| Study group | Role | What they receive |
|---|---|---|
| Participants treated with nivolumab +/- ipilimumab for unresectable/metastatic melanoma | Not described Receives: Drug: Nivolumab +/- ipilimumab | |
| Participants treated with nivolumab as adjuvant therapy for resected stage IIB-IV melanoma | Not described Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-related adverse events
Measured: Up to 100 days after treatment discontinuation
Incidence of all-cause adverse events
Measured: Up to 100 days after treatment discontinuation
Secondary outcomes (39)
Participant year of birth
Measured: Six months prior to index date
Participant gender
Measured: Six months prior to index date
Participant race
Measured: Six months prior to index date
Participant ethnicity
Measured: Six months prior to index date
Participant state/region of residence
Measured: Six months prior to index date
Participant primary insurance payer at treatment initiation
Measured: Six months prior to index date
Date of initial melanoma diagnosis
Measured: Six months prior to index date
Date of index resection for participants treated with adjuvant nivolumab
Measured: Six months prior to index date
Participant height
Measured: Initiation of index treatment
Participant weight
Measured: Initiation of index treatment
Stage of melanoma at diagnosis, assessed by American Joint Committee on Cancer criteria
Measured: Six months prior to index date
Margins at index resection for participants treated with adjuvant nivolumab after resection
Measured: Six months prior to index date
Lymph node biopsy results
Measured: Six months prior to index date
Lymph node involvement - Stage III/IV only
Measured: Six months prior to index date
Tumor ulceration status
Measured: Six months prior to index date
Tumor ulceration characteristics
Measured: Six months prior to index date
Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
Measured: Initiation of index treatment
Lactate dehydrogenase level
Measured: Initiation of index treatment
Index treatment
Measured: Initiation of index treatment
Number of lines of therapy received for unresectable/metastatic melanoma
Measured: From index therapy initiation to death or the date of last follow-up/study end date, whichever came first, assessed up to 108 months
Number of lines of therapy received post resection
Measured: From index therapy initiation to death or the date of last follow-up/study end date, whichever came first, assessed up to 108 months
Disease response characteristics
Measured: From index therapy initiation to death or the date of last follow-up/study end date, whichever came first, assessed up to 108 months
Disease recurrence characteristics
Measured: From index therapy initiation to death or the date of last follow-up/study end date, whichever came first, assessed up to 108 months
Duration of therapy (DOT)
Measured: From index therapy initiation to death or the date of last follow-up/study end date, whichever came first, assessed up to 108 months
Time to next treatment (TTNT)
Measured: From index therapy initiation to next subsequent systemic melanoma treatment post-nivolumab, death, or the date of last follow-up/study end date, whichever came first, assessed up to 108 months
Treatment-free interval (TFI)
Measured: From discontinuation of index treatment to date of initiation of subsequent therapy, assessed up to 108 months
Overall survival (OS)
Measured: From index therapy initiation to death or the date of last follow-up/study end date, whichever came first, assessed up to 108 months
Healthcare resource utilization assessed by the number of inpatient hospitalizations
Measured: From initiation of therapy until end of data collection date or death, whichever came first, assessed up to 108 months
Healthcare resource utilization assessed by the number of emergency department (ED) visits
Measured: From initiation of therapy until end of data collection date or death, whichever came first, assessed up to 108 months
Overall response rate (ORR) in participants with unresectable or metastatic disease
Number of participants with complete or partial response divided by the total number of participants
Measured: From index therapy initiation to the date of last follow-up/study end date, whichever came first, assessed up to 108 months
Progression-free survival (PFS) in participants with unresectable or metastatic disease
Measured: From index therapy initiation to date of first documented disease progression, death, or the date of last follow-up/study end date, whichever came first, assessed up to 108 months
Time to initial response (TTR) in participants with unresectable or metastatic disease
Measured: From index therapy initiation to date of the first physician-reported response (complete or partial response), assessed up to 108 months
Duration of response (DOR) in participants with unresectable or metastatic disease
Measured: From date of first physician-reported response (complete or partial response) to date of the first physician-reported disease progression, death, or date of last follow-up/study end date, whichever came first, assessed up to 108 months
Time to progression (TTP) in participants with unresectable or metastatic disease
Measured: From index therapy initiation to date of physician-reported disease progression, or the date of last follow-up/study end date, whichever came first, assessed up to 108 months
Time to local disease recurrence in participants with resected disease
Measured: From index therapy initiation to date of last follow-up/study end date, whichever came first, assessed up to 108 months
Recurrence free survival (RFS) in participants with resected disease
Measured: From index therapy initiation to date of first melanoma recurrence, death, or the date of last follow-up/study end date, whichever came first, assessed up to 108 months
Time to distant metastases in participants with resected disease
Measured: From index therapy initiation to date of last follow/up or study end date, whichever came first, assessed up to 108 months
Distant-metastasis free survival (DMFS) in participants with resected disease
Measured: From index therapy initiation to date of first distant melanoma metastasis, death, or the date of last follow-up/study end date, whichever came first, assessed up to 108 months
Type of disease recurrence/metastasis in participants with resected disease
Measured: From index therapy initiation to date of last follow-up visit or study end date, whichever came first, assessed up to 108 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start14 Aug 2023
- Primary completion25 Sep 2023
- Study completion10 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Retrospective
- Enrolment
- 100 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
- NCT06163170
- Sponsor's protocol ID
- CA209-1068
- Status last verified
- Apr 2024
- First submitted
- 20 Oct 2023
- Last updated
- 18 Apr 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Evaluation of Patient Characteristics, Treatment Patterns, Safety, and Efficacy of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab for Pediatric Melanoma
- ClinicalTrials.gov ID
- NCT06163170
- Acronym / sponsor ID
- CA209-1068
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 25 Sep 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 8 Dec 2023 (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.
The purpose of this study is to describe real-world safety outcomes in children with melanoma who are treated with nivolumab alone or nivolumab in combination with ipilimumab for unresectable or metastatic melanoma, or treated with adjuvant nivolumab after resection of stage IIB-IV melanoma. Demographic and clinical characteristics, and treatment patterns, will also be described in this population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants treated with nivolumab +/- ipilimumab for unresectable/metastatic melanoma | – | Drug: Nivolumab +/- ipilimumab |
| Participants treated with nivolumab as adjuvant therapy for resected stage IIB-IV melanoma | – | Drug: Nivolumab |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric participants (<18 years of age) who were treated with nivolumab monotherapy or nivolumab combined with ipilimumab for unresectable or metastatic melanoma or treated with adjuvant nivolumab after resection of stage IIb-IV melanoma
Key inclusion criteria (5 listed)
- Participants with confirmed diagnosis of unresectable or metastatic cutaneous melanoma, or stage IIB-IV cutaneous melanoma who have undergone complete resection
- Initiated treatment with nivolumab monotherapy or in combination with ipilimumab for unresectable or metastatic melanoma, or as adjuvant therapy for resected stage IIb-IV melanoma, between January 1, 2015 and 6 months prior to data collection
- For the adjuvant nivolumab cohort, initiated treatment with nivolumab for stage IIb-IV melanoma within 12 weeks following index resection
- Aged <18 years at the time of nivolumab/ipilimumab treatment initiation
- At least 6 months of follow-up from index treatment date (unless deceased prior to end of 6 months)
Key exclusion criteria (2 listed)
- Prior malignancy active within 3 years prior to nivolumab or ipilimumab treatment index date except for locally curable cancers that have been apparently cured (such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast)
- Receiving nivolumab therapy (monotherapy, combination with ipilimumab, or adjuvant therapy) for melanoma as part of a clinical trial during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nivolumab +/- ipilimumabParticipants treated with nivolumab +/- ipilimumab for unresectable/metastatic melanoma | Drug | Participants treated with nivolumab +/- ipilimumab for unresectable/metastatic melanoma |
| NivolumabParticipants treated with nivolumab as adjuvant therapy for resected stage IIB-IV melanoma | Drug | Participants treated with nivolumab as adjuvant therapy for resected stage IIB-IV melanoma |
Primary outcome
Incidence of treatment-related adverse events
Time frame: Up to 100 days after treatment discontinuation
Incidence of all-cause adverse events
Time frame: Up to 100 days after treatment discontinuation
39 secondary outcomes
Participant year of birth
Time frame: Six months prior to index date
Participant gender
Time frame: Six months prior to index date
Participant race
Time frame: Six months prior to index date
Participant ethnicity
Time frame: Six months prior to index date
Participant state/region of residence
Time frame: Six months prior to index date
Participant primary insurance payer at treatment initiation
Time frame: Six months prior to index date
Date of initial melanoma diagnosis
Time frame: Six months prior to index date
Date of index resection for participants treated with adjuvant nivolumab
Time frame: Six months prior to index date
Participant height
Time frame: Initiation of index treatment
Participant weight
Time frame: Initiation of index treatment
Stage of melanoma at diagnosis, assessed by American Joint Committee on Cancer criteria
Time frame: Six months prior to index date
Margins at index resection for participants treated with adjuvant nivolumab after resection
Time frame: Six months prior to index date
Lymph node biopsy results
Time frame: Six months prior to index date
Lymph node involvement - Stage III/IV only
Time frame: Six months prior to index date
Tumor ulceration status
Time frame: Six months prior to index date
Tumor ulceration characteristics
Time frame: Six months prior to index date
Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
Time frame: Initiation of index treatment
Lactate dehydrogenase level
Time frame: Initiation of index treatment
Index treatment
Time frame: Initiation of index treatment
Number of lines of therapy received for unresectable/metastatic melanoma
Time frame: From index therapy initiation to death or the date of last follow-up/study end date, whichever came first, assessed up to 108 months
Number of lines of therapy received post resection
Time frame: From index therapy initiation to death or the date of last follow-up/study end date, whichever came first, assessed up to 108 months
Disease response characteristics
Time frame: From index therapy initiation to death or the date of last follow-up/study end date, whichever came first, assessed up to 108 months
Disease recurrence characteristics
Time frame: From index therapy initiation to death or the date of last follow-up/study end date, whichever came first, assessed up to 108 months
Duration of therapy (DOT)
Time frame: From index therapy initiation to death or the date of last follow-up/study end date, whichever came first, assessed up to 108 months
Time to next treatment (TTNT)
Time frame: From index therapy initiation to next subsequent systemic melanoma treatment post-nivolumab, death, or the date of last follow-up/study end date, whichever came first, assessed up to 108 months
Treatment-free interval (TFI)
Time frame: From discontinuation of index treatment to date of initiation of subsequent therapy, assessed up to 108 months
Overall survival (OS)
Time frame: From index therapy initiation to death or the date of last follow-up/study end date, whichever came first, assessed up to 108 months
Healthcare resource utilization assessed by the number of inpatient hospitalizations
Time frame: From initiation of therapy until end of data collection date or death, whichever came first, assessed up to 108 months
Healthcare resource utilization assessed by the number of emergency department (ED) visits
Time frame: From initiation of therapy until end of data collection date or death, whichever came first, assessed up to 108 months
Overall response rate (ORR) in participants with unresectable or metastatic disease
Time frame: From index therapy initiation to the date of last follow-up/study end date, whichever came first, assessed up to 108 months
Progression-free survival (PFS) in participants with unresectable or metastatic disease
Time frame: From index therapy initiation to date of first documented disease progression, death, or the date of last follow-up/study end date, whichever came first, assessed up to 108 months
Time to initial response (TTR) in participants with unresectable or metastatic disease
Time frame: From index therapy initiation to date of the first physician-reported response (complete or partial response), assessed up to 108 months
Duration of response (DOR) in participants with unresectable or metastatic disease
Time frame: From date of first physician-reported response (complete or partial response) to date of the first physician-reported disease progression, death, or date of last follow-up/study end date, whichever came first, assessed up to 108 months
Time to progression (TTP) in participants with unresectable or metastatic disease
Time frame: From index therapy initiation to date of physician-reported disease progression, or the date of last follow-up/study end date, whichever came first, assessed up to 108 months
Time to local disease recurrence in participants with resected disease
Time frame: From index therapy initiation to date of last follow-up/study end date, whichever came first, assessed up to 108 months
Recurrence free survival (RFS) in participants with resected disease
Time frame: From index therapy initiation to date of first melanoma recurrence, death, or the date of last follow-up/study end date, whichever came first, assessed up to 108 months
Time to distant metastases in participants with resected disease
Time frame: From index therapy initiation to date of last follow/up or study end date, whichever came first, assessed up to 108 months
Distant-metastasis free survival (DMFS) in participants with resected disease
Time frame: From index therapy initiation to date of first distant melanoma metastasis, death, or the date of last follow-up/study end date, whichever came first, assessed up to 108 months
Type of disease recurrence/metastasis in participants with resected disease
Time frame: From index therapy initiation to date of last follow-up visit or study end date, whichever came first, assessed up to 108 months
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 18 Apr 2024.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 United States.
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 5 inclusion and 2 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 18 Apr 2024. 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 United States. 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?
Incidence of treatment-related adverse events (time frame: Up to 100 days after treatment discontinuation). 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?
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 18 Apr 2024.