Safety Study of AMG 820 and Pembrolizumab Combination in Select Advanced Solid Tumour Cancer

Official Title

A Phase1b/2 Study Assessing Safety and Anti-tumour Activity of AMG 820 in Combination With Pembrolizumab in Select Advanced Solid Tumours

Summary:

A multi-centre Phase 1b/2 study testing the combination of AMG 820 and pembrolizumab in subjects with select advanced solid tumours.

Trial Description

Primary Outcome:

  • Number of participants with treatment related adverse events as assessed by CTCAE version 4.0
  • Objective response rate of tumours using irRECIST criteria for total measureable tumour burden
  • Number of participants with treatment emergent adverse events as assessed by CTCAE version 4.0
Secondary Outcome:
  • Objective response rate of tumours using RECIST 1.1 criteria for total measurable tumour burden
  • Maximum observed concentration [Cmax] of AMG820
  • CD4, CD8, and CD68 cell numbers in pre-treatment tumour biopsy tissue
  • Minimum observed concentration [Cmin] of AMG 820
  • Area Under the Curve [AUC] of AMG820
Phase 1b is AMG 820 dose determining and aimed at assessing the safety and tolerability of the selected starting dose of AMG 820 in combination with pembrolizumab. Phase 2 of the study will further evaluate safety and tolerability and additionally test whether AMG 820 can enhance the anti-tumour activity observed historically with pembrolizumab alone and/or overcome lack of response to pembrolizumab monotherapy in subjects with select solid tumours.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society