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A Phase 1/2 Study of Relatlimab (Anti-LAG-3 Monoclonal Antibody) Administered in Combination With Both Nivolumab (Anti-PD-1 Monoclonal Antibody) and BMS-986205 (IDO1 Inhibitor) or in Combination With Both Nivolumab and Ipilimumab (Anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors - CA224-048

Studio Clinico

Patologia: Neoplasie del polmone, Melanoma, Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: I, II

Richiesta mandatoria di tessuto: 

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

Centri partecipanti

Nord Italia

IRCCS - IRST
Via P. Maroncelli 40 - 47014 Meldola - FC

Riferimento: Dr. Massimo Guidoboni

 

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: 2018-000058-22

Data di inserimento: 03.05.2019

Promotore

Bristol-Myers Squibb

CRO

/

Principal Investigator ITALIA

Istituto Nazionale dei Tumori IRCCS - Fondazione Pascale

Riferimento: Dr. Paolo Ascierto

Telefono: 0815903236

Email: p.ascierto@istitutotumori.na.it

Localita: Napoli

 

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