Patologia: Altre neoplasie
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 di controllo:
Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI
Riferimento: Francesca Spada
Istituto Oncologico Veneto IRCCS
Via Gattamelata 64 - 35128 Padova - PD
Azienda Ospedaliera Universitaria Senese
Viale Bracci 16 - 53100 Siena - SI
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA
Riferimento: Dr. Paolo Ascierto
Numero di iscrizione a registro: 2018-002601-57
Data di inserimento: 15.10.2019
Merck Sharp & Dohme Corp.
IEO - Istituto Europeo di Oncologia, Milano
Riferimento: Dr.ssa Francesca Spada