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

Advanced Melanoma Clinical Trial

— MELCAYA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06281912
• Other study ID #: 4504/23
• Status: Not yet recruiting
• Start date: March 2024
• Est. completion date: November 2024

Study information

• Verified date: February 2024
• Source: Azienda Ospedaliera di Perugia
• Contact: Mario Mandala, MD
• Phone: 00393386605619
• Email: mario.mandala[@]unipg.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Melanoma
• Melanoma

Locations

Country	Name	City	State
France	Aix-Marseille Universite	Marseille
France	Institut Curie	Paris
Germany	Ospedale universitario della Charité	Berlino
Germany	German Cancer Research Center (Deutsches Krebsforschungszentrum (DKFZ)	Heidelberg
Germany	University Children's Hospital Tuebingen	Tuebingen
Italy	Universita Degli Studi Di Firenze	Firenze
Italy	Fondazione Irccs Istituto Nazionale Dei Tumori	Milano
Italy	Universita Cattolica Del Sacro Cuore	Roma
Netherlands	Princess Máxima Center for Pediatric Oncology (Prinses Máxima Centrum voor kinderoncologie)	Utrecht
Poland	Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy	Warsaw
Spain	Institut Catala D'Oncologia	Barcellona
Spain	Instituto de Investigaciones Biomédicas August Pi i Sunyer	Barcellona
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera di Perugia

Countries where clinical trial is conducted

France,  Germany,  Italy,  Netherlands,  Poland,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of objective response	efficay of anti PD-1 antibodies in adolescent, childhood and young through Tumor assessment revision adult with early and advanced melanomas	12 months
Secondary	adverse event incidence	Number of AE occurred during treatment defined using CTCAE v5.0	12 months