Impact of Anti PD-1 Therapy in Children, Adolescents and Young Adults (CAYA) Melanoma Patients

Study Purpose

This is a retrospective observational cohort study, the primary objective is investigate the activity and efficacy of anti PD-1 antibodies in children, adolescents and young adult melanoma patients, with radically resected or metastatic disease

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	12 Years - 30 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patients of either sex aged ≥ 12 years; 2. Histologically confirmed melanoma; 3. Anti PD-1 Immunotherapy (Ipilimumab plus Nivolumab); 4. Previous and subsequent treatments will be collected; 5. Clinical and follow-up data available.

Exclusion Criteria:

1. No immunotherapy received; 2. No melanoma; 3. Age > 30 yrs

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06281912
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Azienda Ospedaliera di Perugia
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	France, Germany, Italy, Netherlands, Poland, Spain, Sweden
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Early Melanoma, Advanced Melanoma

Additional Details

The aim of the study is to evaluate the activity and efficacy of anti PD-1 antibodies in adolescent, childhood and young adult with early and advanced melanomas through a multicenter transnational European retrospective analysis Clinical outcomes will be retrospectively retrieved beginning from the primary diagnosis of melanoma. Clinical outcomes will be retrospectively evaluated starting from the time of start of treatment for up to a the most recent follow-up. Data collected will include demographic information, disease history, baseline conditions, clinical outcomes of interest.

Arms & Interventions

Arms

: adolescent/childhood

patients <20 years old with with stage III and IV melanoma diagnosis

: young adult

patients < 30 years with stage III and IV melanoma diagnosis

Interventions

Contact a Trial Team

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