Patologia: Melanoma, Neoplasie del polmone, Altre neoplasie
Osservazionale-Sperimentale: Sperimentale
Monocentrico-Multicentrico: Multicentrico
Randomizzato: No
Fase di studio: I, II
Richiesta mandatoria di tessuto: Sì
Linee di trattamento: Non applicabile
Criteri di inclusione:
- Histologic or cytologic confirmation of an incurable solid malignancy that is advanced (metastatic and/or unresectable), with measurable disease per RECIST v1.1
- Available tumor tissue for biomarker analysis
- Eastern Cooperative Oncology Group Performance Status (ECOG) status of 0 or 1
Criteri di esclusione:
- Participants with known or suspected uncontrolled CNS metastases or with the CNS as the only site of active disease
- Participants with a history of interstitial lung disease (ILD) / pneumonitis
- Prior malignancy active within the previous 3 years except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer
Trattamento sperimentale:
Arm A: Relatlimab + Nivolumab + BMS-986205
Arm B: Relatlimab + Nivolumab + Ipilimumab
Trattamento di controllo:
NA
Obiettivi primari dello studio:
1. Number of clinical laboratory test abnormalities [ Time Frame: approximately 4 years ]
2. Number of Adverse Events (AEs) [ Time Frame: approximately 4 years ]
3. Number of Serious Adverse Events (SAEs) [ Time Frame: approximately 4 years ]
4. Number of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria [ Time Frame: Up to 6 weeks ]
5. Number of AEs leading to discontinuation and deaths [ Time Frame: approximately 4 years ]
6. Objective Response Rate (ORR) [ Time Frame: approximately 4 years ]
7. Disease Control Rate (DCR) [ Time Frame: approximately 4 years ]
8. Median Duration of Response (mDOR) [ Time Frame: approximately 4 years ]
Obiettivi secondari dello studio:
1. Progression Free Survival (PFS) [ Time Frame: up to 4 years ]
Note generali:
Linea di trattamento:
Melanoma prima linea
NSCLC pretrattati
IRCCS - IRST Meldola Dino Amadori
Via P. Maroncelli 40 - 47014 Meldola - FC
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA
Riferimento: Dr. Paolo Ascierto
Telefono: 0815903236
Email: p.ascierto@istitutotumori.na.it
Numero di iscrizione a registro: 2018-000058-22
Data di inserimento: 03.05.2019
Bristol-Myers Squibb
/
Istituto Nazionale dei Tumori IRCCS - Fondazione Pascale
Riferimento: Dr. Paolo Ascierto
Telefono: 0815903236
Email: p.ascierto@istitutotumori.na.it
Localita: Napoli