A Phase 1/2, Open-label Study to Evaluate the Safety and Antitumour Activity of MEDI0680 (AMP-514) in Combination With Durvalumab Versus Nivolumab Monotherapy in Subjects With Select Advanced Malignancies

Official Title

A Phase 1/2, Open-label Study to Evaluate the Safety and Antitumour Activity of MEDI0680 (AMP-514) in Combination With Durvalumab Versus Nivolumab Monotherapy in Subjects With Select Advanced Malignancies

Summary:

To evaluate the Safety and Antitumour Activity of MEDI0680 (AMP-514) in Combination with Durvalumab versus Nivolumab Monotherapy in Subjects with Select Advanced Malignancies.

Trial Description

Primary Outcome:

  • Dose Escalation: Number of subjects with adverse events
  • Dose Expansion: Antitumour activity
Secondary Outcome:
  • Dose Escalation: Antitumour activity of MEDI0680 in combination with MEDI4736 in subjects with select advanced malignancies
  • Dose Expansion: Safety of MEDI0680 Monotherapy and in combination with MEDI4736
  • Dose Expansion: Antitumour activity of MEDI0680 monotherapy and in combination with MEDI4736
  • Both Phases: Pharmacokinetics of MEDI0680 monotherapy and in combination with MEDI4736 and MEDI4736 in combination with MEDI0680
  • Both Phases: Immunogenicity of MEDI0680 and MEDI4736
  • PD-L1 as a predictive biomarker
This is a multicentre, open-label, Phase 1/2 study to evaluate the safety, tolerability, PK, immunogenicity, and antitumour activity of MEDI0680 in combination with durvalumab or nivolumab monotherapy in adult immunotherapy-naïve subjects with selected advanced malignancies.

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