Clinical trial NCT06281912: Impact of Anti PD-1 Therapy in Children, Adolescents and Young Adults (CAYA) Melanoma Patients
Official title: Impact of Anti PD-1 Therapy in Children, Adolescents and Young Adults (CAYA) Melanoma Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Early Melanoma
Advanced Melanoma
Keywords: PD-1 antibodies, childhood, adolescent, melanoma
Lead sponsor: Azienda Ospedaliera di Perugia
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 70
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adolescent, childhood and young adult with early and advanced melanomas treated with anti PD-1 therapy

Brief summary: 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

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: rate of objective response
timeFrame: 12 months
Secondary outcomes:
measure: adverse event incidence
timeFrame: 12 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Aix-Marseille Universite
city: Paris
country: France
facility: Institut Curie
city: Berlino
country: Germany
facility: Ospedale universitario della Charité
city: Heidelberg
country: Germany
facility: German Cancer Research Center (Deutsches Krebsforschungszentrum (DKFZ)
city: Tuebingen
country: Germany
facility: University Children's Hospital Tuebingen
city: Firenze
country: Italy
facility: Universita Degli Studi Di Firenze
city: Milano
country: Italy
facility: Fondazione Irccs Istituto Nazionale Dei Tumori
city: Roma
country: Italy
facility: Universita Cattolica Del Sacro Cuore
city: Utrecht
country: Netherlands
facility: Princess Máxima Center for Pediatric Oncology (Prinses Máxima Centrum voor kinderoncologie)
city: Warsaw
country: Poland
facility: Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
city: Barcellona
country: Spain
facility: Institut Catala D'Oncologia
city: Barcellona
country: Spain
facility: Instituto de Investigaciones Biomédicas August Pi i Sunyer
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
References: