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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Melanoma

Treatments: Drug: Nivolumab; Drug: Nivolumab +/- ipilimumab

Study type: Observational

Funder types: Industry

Identifiers

NCT06163170

CA209-1068

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

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

Treatment:

Drug: Nivolumab +/- ipilimumab

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

Treatment:

Drug: Nivolumab