Registrationsdatum der Studie
25.09.2013
Einschluss der ersten teilnehmenden Person
14.10.2013
Rekrutierungsstatus
Recruiting
Wissenschaftlicher Titel (Datenquelle: WHO)
A Phase I/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors
Studientyp (Datenquelle: WHO)
Interventional
Design der Studie (Datenquelle: WHO)
Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase (Datenquelle: WHO)
Phase 1/Phase 2
Primäre Endpunkte (Datenquelle: WHO)
Proportion of subjects with Adverse Events (AEs);Proportion of subjects with Serious Adverse Events (SAEs);Proportion of Deaths;Proportion of subjects with laboratory abnormalities;Objective response rate (ORR);Disease control rate (DCR)
Sekundäre Endpunkte (Datenquelle: WHO)
Maximum observed serum concentration (Cmax) of BMS-986016 administered both alone and in combination with nivolumab;Time of maximum observed serum concentration (Tmax) of BMS-986016 administered both alone and in combination with nivolumab;Trough observed serum concentration (Ctrough) of BMS-986016 administered both alone and in combination with nivolumab;Concentration at the end of a dosing interval (Ctau) [Eg: concentration at 336 hours] of BMS-986016 administered both alone and in combination with nivolumab;Average concentration over a dosing interval [AUC(TAU)/tau] (Css,avg) of BMS-986016 administered both alone and in combination with nivolumab;Cmax accumulation index; ratio of Cmax at steady state to Cmax after the first dose (AI_Cmax) of BMS-986016 administered both alone and in combination with nivolumab;Progression-free survival (PFS);Duration of response (DOR);DCR;ORR;Best overall response (BOR);QTc interval from centrally read electrocardiograms (ECGs);Immunogenicity measured by ADA for BMS-986016 (all subjects) and nivolumab;Efficacy as measured by tumor assessment (RECIST);Degree of fluctuation (DF) or fluctuation index ([Cmax - Ctau]/Css,avg]) of BMS-986016 administered both alone and in combination with nivolumab;Ctau accumulation index; ratio of Ctau at steady state to Ctau after the first dose (AI_Ctau) of BMS-986016 administered both alone and in combination with nivolumab;Accumulation index; ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose (AI_AUC) of BMS-986016 administered both alone and in combination with nivolumab;Effective elimination half-life that explains the degree of Cmax accumulation observed (T-HALFeff Cmax) of BMS-986016 administered both alone and in combination with nivolumab;Effective elimination half-life that explains the degree of AUC accumulation observed (T-HALFeff AUC) of BMS-986016 administered both alone and in combination with nivolumab;Volume of distribution at steady state (Vss) of BMS-986016 administered both alone and in combination with nivolumab;Total body clearance (CLT) of BMS-986016 administered both alone and in combination with nivolumab;Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-986016 administered both alone and in combination with nivolumab
Kontakt für Auskünfte (Datenquelle: WHO)
Please refer to primary and secondary sponsors