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

Not yet recruiting

• Conditions: Advanced Melanoma; Early Melanoma

• Registration Number: NCT06281912
• Lead Sponsor: Azienda Ospedaliera di Perugia

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.

Study Timeline

• Study First Submitted: 2023-09-22
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-20
• Last Update Submitted: 2024-02-20
• Study First Posted: 2024-02-28
• Last Update Posted: 2024-02-28
• Study Start: 2024-03
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rate of objective response	12 months	efficay of anti PD-1 antibodies in adolescent, childhood and young through Tumor assessment revision adult with early and advanced melanomas

Secondary Outcome Measures

Name	Time	Method
adverse event incidence	12 months	Number of AE occurred during treatment defined using CTCAE v5.0

Trial Locations

Locations (13)

Instituto de Investigaciones Biomédicas August Pi i Sunyer; 🇪🇸 Barcellona, Spain

Aix-Marseille Universite; 🇫🇷 Marseille, France

Institut Curie; 🇫🇷 Paris, France

German Cancer Research Center (Deutsches Krebsforschungszentrum (DKFZ); 🇩🇪 Heidelberg, Germany

Ospedale universitario della Charité; 🇩🇪 Berlino, Germany

University Children's Hospital Tuebingen; 🇩🇪 Tuebingen, Germany

Universita Degli Studi Di Firenze; 🇮🇹 Firenze, Italy

Universita Cattolica Del Sacro Cuore; 🇮🇹 Roma, Italy

Princess Máxima Center for Pediatric Oncology (Prinses Máxima Centrum voor kinderoncologie); 🇳🇱 Utrecht, Netherlands

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy; 🇵🇱 Warsaw, Poland

Fondazione Irccs Istituto Nazionale Dei Tumori; 🇮🇹 Milano, Italy

Institut Catala D'Oncologia; 🇪🇸 Barcellona, Spain

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden