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A Phase 3 Open-label, Single Arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) as First Line Therapy in Participants With Advanced Merkel Cell Carcinoma (KEYNOTE-913 - MK-3475-913)

Studio Clinico

Patologia: Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico


Fase di studio: III

Linee di trattamento: Prima linea

Criteri di inclusione: 

- Be male or female and at least 12 years of age, at the time of signing the informed consent/assent.
- Have histologically confirmed diagnosis of locoregional MCC that has recurred following standard locoregional therapy with surgery and/or radiation therapy and is not amenable to local therapy or metastatic MCC (Stage IV) as per American Joint Committee on Cancer (AJCC) 8th edition guidelines.
- Have been untreated for advanced or metastatic disease except as follows:
    - Prior intratumoral therapy will be permitted.
    - Prior adjuvant or neoadjuvant therapy containing systemic chemotherapy will be permitted if treatment concluded at least 3 months prior to Cycle 1 Day 1 (C1D1).
    - Prior adjuvant or neoadjuvant therapy containing anti-PD-1/L1 or anti-CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) therapy will not be permitted.
- Have at least 1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 criteria as determined by the local site investigator/radiology assessment.
- Toxic effect(s) of the most recent prior therapy have resolved to Grade 1 or less (except alopecia).
- Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- Is not a woman of childbearing potential (WOCBP)
- Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis).
- A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 72 hours before the first dose of study intervention.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or Lansky Play-Performance Scale (LPS) ≥50 for pediatric participants up to and including 16 years of age.
- Have adequate organ function

Criteri di esclusione: 

Has symptomatic congestive heart failure (New York Heart Association Class III or IV heart disease)

Trattamento sperimentale: 


Trattamento di controllo: 


Centri partecipanti

Nord Italia

Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI

Riferimento: Francesca Spada
Telefono: 0257489258


Istituto Oncologico Veneto IRCCS
Via Gattamelata 64 - 35128 Padova - PD


Centro Italia

Azienda Ospedaliera Universitaria Senese
Viale Bracci 16 - 53100 Siena - SI


Sud Italia e isole

Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA

Riferimento: Dr. Paolo Ascierto
Telefono: 0815903236

Informazioni Generali


Numero di iscrizione a registro: 2018-002601-57

Data di inserimento: 15.10.2019


Merck Sharp & Dohme Corp.



Principal Investigator ITALIA

IEO - Istituto Europeo di Oncologia, Milano

Riferimento: Dr.ssa Francesca Spada

Telefono: 0257489258


Localita: Milano


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