Patologia: Altre neoplasie
Fase di studio: II
Richiesta mandatoria di tessuto: Sì
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 di controllo:
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).
IRCCS A.O.U. San Martino - IST
Largo Rosanna Benzi 10 - 16132 Genova - GE
U.O. Oncologia Medica 2
Istituto Nazionale Tumori “Regina Elena”
Via Elio Chianesi 53 - 00144 Roma - RM
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA
Riferimento: Dr. Paolo Ascierto
Numero di iscrizione a registro: NCT03599713
Data di inserimento: 22.03.2019
Data di aggiornamento: 25.07.2019
Istituto Nazionale dei Tumori IRCCS - Fondazione Pascale, Napoli
Riferimento: Dr. Paolo Ascierto