Clinical trial NCT06163170: A Study to Evaluate Treatment With Nivolumab Alone and Nivolumab Combined With Ipilimumab in Children With Melanoma
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-12-08
Enrollment: 100
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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. Demographic and clinical characteristics, and treatment patterns, will also be described in this population.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of treatment-related adverse events
timeFrame: Up to 100 days after treatment discontinuation
measure: Incidence of all-cause adverse events
timeFrame: Up to 100 days after treatment discontinuation
Secondary outcomes:
measure: Participant year of birth
timeFrame: Six months prior to index date
measure: Participant gender
timeFrame: Six months prior to index date
measure: Participant race
timeFrame: Six months prior to index date
measure: Participant ethnicity
timeFrame: Six months prior to index date
measure: Participant state/region of residence
timeFrame: Six months prior to index date
measure: Participant primary insurance payer at treatment initiation
timeFrame: Six months prior to index date
measure: Date of initial melanoma diagnosis
timeFrame: Six months prior to index date
measure: Date of index resection for participants treated with adjuvant nivolumab
timeFrame: Six months prior to index date
measure: Participant height
timeFrame: Initiation of index treatment
measure: Participant weight
timeFrame: Initiation of index treatment
measure: Stage of melanoma at diagnosis, assessed by American Joint Committee on Cancer criteria
timeFrame: Six months prior to index date
measure: Margins at index resection for participants treated with adjuvant nivolumab after resection
timeFrame: Six months prior to index date
measure: Lymph node biopsy results
timeFrame: Six months prior to index date
measure: Lymph node involvement - Stage III/IV only
timeFrame: Six months prior to index date
measure: Tumor ulceration status
timeFrame: Six months prior to index date
measure: Tumor ulceration characteristics
timeFrame: Six months prior to index date
measure: Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
timeFrame: Initiation of index treatment
measure: Lactate dehydrogenase level
timeFrame: Initiation of index treatment
measure: Index treatment
timeFrame: Initiation of index treatment
measure: Number of lines of therapy received for unresectable/metastatic melanoma
timeFrame: From index therapy initiation to death or the date of last follow-up/study end date, whichever came first, assessed up to 108 months
measure: Number of lines of therapy received post resection
timeFrame: From index therapy initiation to death or the date of last follow-up/study end date, whichever came first, assessed up to 108 months
measure: Disease response characteristics
timeFrame: From index therapy initiation to death or the date of last follow-up/study end date, whichever came first, assessed up to 108 months
measure: Disease recurrence characteristics
timeFrame: From index therapy initiation to death or the date of last follow-up/study end date, whichever came first, assessed up to 108 months
measure: Duration of therapy (DOT)
timeFrame: From index therapy initiation to death or the date of last follow-up/study end date, whichever came first, assessed up to 108 months
measure: Time to next treatment (TTNT)
timeFrame: 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
measure: Treatment-free interval (TFI)
timeFrame: From discontinuation of index treatment to date of initiation of subsequent therapy, assessed up to 108 months
measure: Overall survival (OS)
timeFrame: From index therapy initiation to death or the date of last follow-up/study end date, whichever came first, assessed up to 108 months
measure: Healthcare resource utilization assessed by the number of inpatient hospitalizations
timeFrame: From initiation of therapy until end of data collection date or death, whichever came first, assessed up to 108 months
measure: Healthcare resource utilization assessed by the number of emergency department (ED) visits
timeFrame: From initiation of therapy until end of data collection date or death, whichever came first, assessed up to 108 months
measure: Overall response rate (ORR) in participants with unresectable or metastatic disease
timeFrame: From index therapy initiation to the date of last follow-up/study end date, whichever came first, assessed up to 108 months
measure: Progression-free survival (PFS) in participants with unresectable or metastatic disease
timeFrame: 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
measure: Time to initial response (TTR) in participants with unresectable or metastatic disease
timeFrame: From index therapy initiation to date of the first physician-reported response (complete or partial response), assessed up to 108 months
measure: Duration of response (DOR) in participants with unresectable or metastatic disease
timeFrame: 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
measure: Time to progression (TTP) in participants with unresectable or metastatic disease
timeFrame: 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
measure: Time to local disease recurrence in participants with resected disease
timeFrame: From index therapy initiation to date of last follow-up/study end date, whichever came first, assessed up to 108 months
measure: Recurrence free survival (RFS) in participants with resected disease
timeFrame: 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
measure: Time to distant metastases in participants with resected disease
timeFrame: From index therapy initiation to date of last follow/up or study end date, whichever came first, assessed up to 108 months
measure: Distant-metastasis free survival (DMFS) in participants with resected disease
timeFrame: 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
measure: Type of disease recurrence/metastasis in participants with resected disease
timeFrame: From index therapy initiation to date of last follow-up visit or study end date, whichever came first, assessed up to 108 months
Other outcomes:
Locations:
city: Dublin
country: United States
facility: Cardinal Health
state: Ohio
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: