A Phase 1 Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Solid Tumours

Official Title

A Phase I Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination With Tremelimumab (Anti-CTLA-4 Antibody) in Subjects With Advanced Solid Tumours

Summary:

This is a multicentre, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumour activity, PK and immunogenicity of MEDI4736 in combination with tremelimumab in subjects with select advanced solid tumours.

Trial Description

Primary Outcome:

• Number of subjects reporting adverse events
• Number of subjects reporting serious adverse events
• Number of subjects experiencing a dose-limiting toxicity
• Change from Baseline in laboratory evaluations
• Change from Baseline in vital signs
• Change from Baseline in electrocardiogram evaluations
• Overall Response Rate in Select Tumour Types

• Overall Response Rate
• Disease Control Rate
• Duration of Response
• Progression-Free Survival
• Overall Survival
• Individual MEDI4736 concentrations
• Individual tremelimumab concentrations
• MEDI4736 area under the concentration-curve
• Tremelimumab area under the concentration-curve
• Number of subjects that develop detectable antidrug antibodies to MEDI4736
• Number of subjects that develop antidrug antibodies to tremelimumab

View this trial on ClinicalTrials.gov