The purpose of this study was to combine the PDR001 checkpoint inhibitor with each of four agents with immunomodulatory activity to identify the doses and schedule for combination therapy and to preliminarily assess the safety, tolerability, pharmacological and clinical activity of these combinations.
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Frequency of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) as a measure of safety
Timeframe: Throughout the study at every visit, an average of 1 year
Changes between baseline and post-baseline laboratory parameters and vital signs.
Timeframe: Baseline and throughout the study at every visit, an average of 1 year
Incidence of dose limiting toxicities (DLTs) of treatment (Escalation only)
Timeframe: During the first two cycles; Cycle = 28 days
Frequency of dose interruptions
Timeframe: Throughout the study at every visit, an average of 1 year
Dose intensities
Timeframe: Throughout the study at every visit, an average of 1 year
Severity of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) as a measure of safety
Timeframe: Throughout the study at every visit, an average of 1 year
Frequency of dose reductions
Timeframe: Throughout the study at every visit, an average of 1 year