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A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel Cell Carcinoma - INCMGA0012-201

Studio Clinico

Patologia: Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Richiesta mandatoria di tessuto: 

Linee di trattamento: Prima linea, Seconda linea, Terza/N linea

Criteri di inclusione: 

- Signed informed consent.
- Diagnosis of MCC with distant metastatic disease as a component of tumor burden and no more than 3 prior systemic treatments, inclusive of systemic adjuvant therapy.
- 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 programmed cell death protein 1 (PD-1) or programmed cell death ligand protein 1 (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 in 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 90 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.

Schema di trattamento: 

INCMGA00012 administered at the recommended Phase 2 dose by IV infusion once every 28 days.

Trattamento sperimentale: 

INCMGA00012

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

Overall response rate in chemotherapy-naive participants [ Time Frame: Up to approximately 3 years ]
Defined as the percentage of participants with an objective response (complete response [CR] or partial response [PR]) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as determined by independent central radiographic review (ICR).

Centri partecipanti

Centro Italia

Istituto Nazionale Tumori “Regina Elena”
Via Elio Chianesi 53 - 00144 Roma - RM

Riferimento: Dr. Giancarlo Antonini Cappellini

 

Sud Italia e isole

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

Riferimento: Dr. Paolo Ascierto
Telefono: 0815903236
Email: p.ascierto@istitutotumori.na.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NCT03599713

Data di inserimento: 22.03.2019

Promotore

Incyte Corporation

CRO

na

Principal Investigator ITALIA

Istituto Nazionale dei Tumori IRCCS - Fondazione Pascale, Napoli

Riferimento: Dr. Paolo Ascierto

Telefono: 0815903236

Email: p.ascierto@istitutotumori.na.it

Localita: Napoli

 

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