Melanoma Clinical Trial

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

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.

View Eligibility Criteria

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

Study is for people with:

Melanoma

Estimated Enrollment:

100

Study ID:

NCT06163170

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There is 1 Location for this study

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Cardinal Health
Dublin Ohio, 43017, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Estimated Enrollment:

100

Study ID:

NCT06163170

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

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