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Completed

NCT Number: NCT06163170

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

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardinal Health

Dublin, Ohio, 43017, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nivolumab +/- ipilimumab

Drug

Participants treated with nivolumab +/- ipilimumab for unresectable/metastatic melanoma

Nivolumab

Drug

Participants treated with nivolumab as adjuvant therapy for resected stage IIB-IV melanoma

Primary outcomes

  1. Incidence of treatment-related adverse events

    Time frame: Up to 100 days after treatment discontinuation

  2. Incidence of all-cause adverse events

    Time frame: Up to 100 days after treatment discontinuation

Secondary outcomes

  1. Participant year of birth

    Time frame: Six months prior to index date

  2. Participant gender

    Time frame: Six months prior to index date

  3. Participant race

    Time frame: Six months prior to index date

  4. Participant ethnicity

    Time frame: Six months prior to index date

  5. Participant state/region of residence

    Time frame: Six months prior to index date

  6. Participant primary insurance payer at treatment initiation

    Time frame: Six months prior to index date

  7. Date of initial melanoma diagnosis

    Time frame: Six months prior to index date

  8. Date of index resection for participants treated with adjuvant nivolumab

    Time frame: Six months prior to index date

  9. Participant height

    Time frame: Initiation of index treatment

  10. Participant weight

    Time frame: Initiation of index treatment

  11. Stage of melanoma at diagnosis, assessed by American Joint Committee on Cancer criteria

    Time frame: Six months prior to index date

  12. Margins at index resection for participants treated with adjuvant nivolumab after resection

    Time frame: Six months prior to index date

  13. Lymph node biopsy results

    Time frame: Six months prior to index date

  14. Lymph node involvement - Stage III/IV only

    Time frame: Six months prior to index date

  15. Tumor ulceration status

    Time frame: Six months prior to index date

  16. Tumor ulceration characteristics

    Time frame: Six months prior to index date

  17. Eastern Cooperative Oncology Group Performance Status (ECOG-PS)

    Time frame: Initiation of index treatment

  18. Lactate dehydrogenase level

    Time frame: Initiation of index treatment

  19. Index treatment

    Time frame: Initiation of index treatment

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. Treatment-free interval (TFI)

    Time frame: From discontinuation of index treatment to date of initiation of subsequent therapy, assessed up to 108 months

  27. 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

  28. 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

  29. 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

  30. 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

    Number of participants with complete or partial response divided by the total number of participants

  31. 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

  32. 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

  33. 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

  34. 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

  35. 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

  36. 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

  37. 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

  38. 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

  39. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Real-World Evaluation of Patient Characteristics, Treatment Patterns, Safety, and Efficacy of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab for Pediatric Melanoma

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 8, 2023
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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