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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06281912

Acronym

MELCAYA

Enrollment

Registered

2024-02-28

Start date

2024-03-31

Completion date

2024-11-30

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Melanoma, Early Melanoma

Keywords

PD-1 antibodies, childhood, adolescent, melanoma

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to 30 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
adverse event incidence	12 months	Number of AE occurred during treatment defined using CTCAE v5.0

Countries

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

Contacts

Primary ContactMario Mandala, MD

mario.mandala@unipg.it00393386605619

Backup ContactRoberta Matocci

roberta.matocci@ospedale.perugia.it+390755784099

Outcome results