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A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma - INCMGA00012-201 (POD1UM-201)

Studio Clinico

Patologia: Carcinoma a cellule di Merkel

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Richiesta mandatoria di tessuto: 

Linee di trattamento: Prima linea

Criteri di inclusione: 

- Signed informed consent.
- Diagnosis of MCC with distant metastatic disease or recurrent, advanced locoregional disease not amenable to surgery or radiation
- Eastern Cooperative Oncology Group performance status of 0 to 1.
- Measurable disease according to RECIST v1.1.
- Availability of tumor tissue (fresh or archival) for central pathology review.
- Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.

Criteri di esclusione: 

- Prior systemic therapy for MCC, including chemotherapy and prior PD-1 or PD-L1-directed therapy.
- Treatment with anticancer drugs or participation in another interventional clinical study within 21 days before the first administration of study drug.
- Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy (with the exceptions for anemia not requiring transfusion support and any grade of alopecia) and/or complications from prior surgical intervention within 7 days before starting study treatment.
- Radiation therapy administered within 2 weeks of first dose of study treatment or radiation therapy to the thoracic region that is > 30 Gy within 6 months of the first dose of study treatment.
- Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
- History of second malignancy within 3 years (with exceptions).
- Laboratory values outside the protocol-defined range at screening.
- Clinically significant pulmonary, cardiac, gastrointestinal or autoimmune disorders.
- Active bacterial, fungal, or viral infections, including hepatitis A, B, and C.
- Receipt of a live vaccine within 28 days of planned start of study therapy.
- Current use of protocol-defined prohibited medication.
- Known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures (eg, antihistamines and corticosteroids).
- Inability or unlikely, in the opinion of the investigator, to comply with the Protocol requirements.
- Participant who is pregnant or breastfeeding.

Trattamento sperimentale: 

Retifanlimab

Trattamento di controllo: 

NA

Centri partecipanti

Nord Italia

IRCCS A.O.U. San Martino - IST
Largo Rosanna Benzi 10 - 16132 Genova - GE

 

IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI

 

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

 

A.O.U. Policlinico di Modena
Via del Pozzo 71 - 41100 Modena - MO

 

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

 

IRCCS Candiolo (TO)
St.Provinciale Km 3,95 SP142 - 10060 Candiolo - TO
Fondazione del Piemonte per l'Oncologia

 

Centro Italia

Istituto Dermopatico dell'Immacolata
Via Monti di Creta 104 - 00167 Roma - RM

 

Azienda Ospedaliera Universitaria Senese
Viale Bracci 16 - 53100 Siena - SI
Policlinico Le Scotte

 

Sud Italia e isole

Istituto Tumori “Giovanni Paolo II” IRCCS
Viale Orazio Flacco 65 - 70124 Bari - BA

 

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

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2018-001627-39

Data di inserimento: 11.06.2021

Promotore

Incyte Corporation

CRO

IQVIA

Principal Investigator ITALIA

AOU Senese - Policlinico Le Scotte, Siena

Riferimento: Dr. non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: Siena

 

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