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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-14

Study Completion Date

2023-11-10

Brief Summary

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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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Detailed Description

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Conditions

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Melanoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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

Nivolumab +/- ipilimumab

Intervention Type DRUG

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

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

Nivolumab

Intervention Type DRUG

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

Interventions

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Nivolumab +/- ipilimumab

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

Intervention Type DRUG

Nivolumab

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

Intervention Type DRUG

Eligibility Criteria

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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

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No