A Study to Evaluate Treatment With Nivolumab Alone and Nivolumab Combined With Ipilimumab in Children With Melanoma

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06163170
• Other study ID #: CA209-1068
• Status: Completed
• Start date: August 14, 2023
• Est. completion date: November 10, 2023

Study information

• Verified date: April 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 10, 2023
• Est. primary completion date: September 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• Nivolumab +/- ipilimumab
Participants treated with nivolumab +/- ipilimumab for unresectable/metastatic melanoma
• Nivolumab
Participants treated with nivolumab as adjuvant therapy for resected stage IIB-IV melanoma

Locations

Country	Name	City	State
United States	Cardinal Health	Dublin	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls