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

Noch nicht rekrutierend

NCT-Nummer:
NCT06281912

Studienbeginn:
März 2024

Letztes Update:
28.02.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Melanoma

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

Sponsor:
Azienda Ospedaliera di Perugia

Collaborator:
-

Kontakt

Mario Mandala, MD
Kontakt:
Phone: 00393386605619
E-Mail: mario.mandala@unipg.it» Kontaktdaten anzeigen

Roberta Matocci
Kontakt:
Phone: +390755784099
E-Mail: roberta.matocci@ospedale.perugia.it» Kontaktdaten anzeigen

Studienlocations
(3 von 13)

Ospedale universitario della Charité
Berlino
(Berlin)
Germany» Google-Maps

German Cancer Research Center (Deutsches Krebsforschungszentrum (DKFZ)
Heidelberg
(Baden-Württemberg)
Germany» Google-Maps

University Children's Hospital Tuebingen
Tuebingen
(Baden-Württemberg)
Germany» Google-Maps

Aix-Marseille Universite
Marseille
France» Google-Maps

Institut Curie
Paris
France» Google-Maps

Universita Degli Studi Di Firenze
Firenze
Italy» Google-Maps

Fondazione Irccs Istituto Nazionale Dei Tumori
Milano
Italy» Google-Maps

Universita Cattolica Del Sacro Cuore
Roma
Italy» Google-Maps

Princess Máxima Center for Pediatric Oncology (Prinses Máxima Centrum voor kinderoncologie)
Utrecht
Netherlands» Google-Maps

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Warsaw
Poland» Google-Maps

Institut Catala D'Oncologia
Barcellona
Spain» Google-Maps

Instituto de Investigaciones Biomédicas August Pi i Sunyer
Barcellona
Spain» Google-Maps

Karolinska University Hospital
Stockholm
Sweden» Google-Maps

Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. rate of objective response (Time Frame - 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:

1. adverse event incidence (Time Frame - 12 months):
Number of AE occurred during treatment defined using CTCAE v5.0

Studien-Arme

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

Quelle: ClinicalTrials.gov