Early MelanomaMELCAYANCT06281912
Impact of Anti PD-1 Therapy in Children, Adolescents and Young Adults (CAYA) Melanoma Patients
An observational study of Early Melanoma and Advanced Melanoma, run by Azienda Ospedaliera di Perugia at 13 sites in 7 countries.
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 Read more about this study
- Who is it for?
- Ages 12 to 30 years
- Conditions the study is for
- Early Melanoma, Advanced Melanoma
- Type of treatment
- Injection or infusion
- How many people
- 70 participants
- Where
- 13 sitesin 7 countries
- Study dates
- Mar 2024to Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescent, childhood and young adult with early and advanced melanomas treated with anti PD-1 therapy
Who may be able to join
- 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
Who cannot join
- No immunotherapy received;
- No melanoma;
- Age > 30 yrs
Trial locations and contacts
13 sites in 7 countries.
13 sites in 7 countries
Germany3 sites
Ospedale universitario della Charité
Berlin
German Cancer Research Center (Deutsches Krebsforschungszentrum (DKFZ)
Heidelberg
University Children's Hospital Tuebingen
Tübingen
Italy3 sites
Universita Degli Studi Di Firenze
Florence
Fondazione Irccs Istituto Nazionale Dei Tumori
Milan
Universita Cattolica Del Sacro Cuore
Roma
Spain2 sites
Institut Catala D'Oncologia
Barcelona
Instituto de Investigaciones Biomédicas August Pi i Sunyer
Barcelona
Netherlands1 site
Princess Máxima Center for Pediatric Oncology (Prinses Máxima Centrum voor kinderoncologie)
Utrecht
Poland1 site
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Warsaw
About this study
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
Read the 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.
- Conditions
- Early Melanoma, Advanced Melanoma
- Keywords
- PD-1 antibodies, childhood, adolescent, melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (1)
adverse event incidence
Number of AE occurred during treatment defined using CTCAE v5.0
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study startMar 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Perugia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Mandalà, Azienda Ospedaliera di Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281912
- Sponsor's protocol ID
- 4504/23
- Acronym
- MELCAYA
- Status last verified
- Feb 2024
- First submitted
- 22 Sep 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Anti PD-1 Therapy in Children, Adolescents and Young Adults (CAYA) Melanoma Patients
- ClinicalTrials.gov ID
- NCT06281912
- Acronym / sponsor ID
- MELCAYA / 4504/23
- Conditions
- Early Melanoma, Advanced Melanoma
- Keywords
- PD-1 antibodies, childhood, adolescent, melanoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera di PerugiaUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescent, childhood and young adult with early and advanced melanomas treated with anti PD-1 therapy
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- No immunotherapy received;
- No melanoma;
- Age > 30 yrs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
adverse event incidence
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
13 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Melanoma and Advanced Melanoma, run by Azienda Ospedaliera di Perugia at 13 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany, Italy, France, Spain, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mario Mandala, MD (00393386605619, mario.mandala@unipg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of objective response (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.