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


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
Secondary Outcome:
  • 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

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.


Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society