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

NCT06281912 | Not Yet Recruiting

• 1 other identifier: 4504/23
• Study Type: observational
• Target: 70
• Locations: 7 countries
• Sites: 13

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

Conditions

Early Melanoma; Advanced Melanoma

Keywords

PD-1 antibodies, childhood, adolescent, melanoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• adverse event incidence

  12 months

Study Arms (2)

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

Eligibility Criteria

• Age: 12 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Adolescent, childhood and young adult with early and advanced melanomas treated with anti PD-1 therapy

You may qualify if:

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

You may not qualify if:

• No immunotherapy received;
• No melanoma;
• Age \> 30 yrs

Sponsors & Collaborators

• Azienda Ospedaliera di Perugia: lead

Study Sites (13)

Aix-Marseille Universite

Marseille, France

Location

Institut Curie

Paris, France

Location

Ospedale universitario della Charité

Berlin, Germany

Location

German Cancer Research Center (Deutsches Krebsforschungszentrum (DKFZ)

Heidelberg, Germany

Location

University Children's Hospital Tuebingen

Tübingen, Germany

Location

Universita Degli Studi Di Firenze

Florence, Italy

Location

Fondazione Irccs Istituto Nazionale Dei Tumori

Milan, Italy

Location

Universita Cattolica Del Sacro Cuore

Roma, Italy

Location

Princess Máxima Center for Pediatric Oncology (Prinses Máxima Centrum voor kinderoncologie)

Utrecht, Netherlands

Location

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Warsaw, Poland

Location

Institut Catala D'Oncologia

Barcelona, Spain

Location

Instituto de Investigaciones Biomédicas August Pi i Sunyer

Barcelona, Spain

Location

Karolinska University Hospital

Stockholm, Sweden

Location

MeSH Terms

Conditions

Melanoma

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

Central Study Contacts

Mario Mandala, MD

CONTACT

00393386605619; mario.mandala@unipg.it

Roberta Matocci

CONTACT

+390755784099; roberta.matocci@ospedale.perugia.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: February 28, 2024
• Study Start: March 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); ES (2); SE (1); DE (3); IT (3); PL (1); FR (2)