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

NCT06163170 | Completed FDA Drug

• 1 other identifier: CA209-1068
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (2)

• Incidence of treatment-related adverse events

  Up to 100 days after treatment discontinuation

• Incidence of all-cause adverse events

  Up to 100 days after treatment discontinuation

Secondary Outcomes (39)

• Participant year of birth

  Six months prior to index date

• Participant gender

  Six months prior to index date

• Participant race

  Six months prior to index date

• Participant ethnicity

  Six months prior to index date

• Participant state/region of residence

  Six months prior to index date

Study Arms (2)

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

Drug: Nivolumab +/- ipilimumab

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

Drug: Nivolumab

Interventions

Nivolumab +/- ipilimumab DRUG

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

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

Nivolumab DRUG

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

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

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric participants (\<18 years of age) who were treated with nivolumab monotherapy or nivolumab combined with ipilimumab for unresectable or metastatic melanoma or treated with adjuvant nivolumab after resection of stage IIb-IV melanoma

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Cardinal Health

Dublin, Ohio, 43017, United States

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Melanoma

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: December 8, 2023
• Study Start: August 14, 2023
• Primary Completion: September 25, 2023
• Study Completion: November 10, 2023
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)