A Study to Assess the Safety and Pharmacokinetics of MOXR0916 and Atezolizumab (Also Known as MPDL3280A or Anti-PD-L1) in Participants With Locally Advanced or Metastatic Solid Tumours

Official Title

A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of MOXR0916 and Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumours

Summary:

This Phase Ib, open-label, dose-escalation study will evaluate the safety, tolerability, and pharmacokinetics of the combination of MOXR0916 and atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid malignancy that has progressed after available standard therapy; or for which standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for which a clinical trial of an investigational agent is a recognized standard of care. Participants will be enrolled in two stages: a dose-escalation stage and an expansion stage.

Trial Description

Primary Outcome:

  • Number of Participants with Dose-Limiting Toxicities (DLTs)
  • Number of Participants with Adverse Events Graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0
Secondary Outcome:
  • Maximum Tolerated Dose (MTD) of MOXR0916
  • Recommended Phase II Dose (RP2D) of MOXR0916
  • Percentage of Participants with Anti-MOXR0916 and Anti-Atezolizumab Antibodies
  • Number of Cycles Received with MOXR0916
  • Dose Intensity of MOXR0916
  • Area under the Concentration-Time Curve (AUC) of MOXR0916
  • Serum Maximum Observed Concentration (Cmax) of MOXR0916
  • Serum Minimum Observed Concentration (Cmin) of MOXR0916
  • Clearance (CL) of MOXR0916
  • Volume of Distribution at Steady State (Vss) of MOXR0916
  • Serum Cmax of Atezolizumab
  • Serum Cmin of Atezolizumab
  • Percentage of Participants with Objective Response Determined Using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
  • Duration of Objective Response (DOR) Determined Using RECIST v1.1
  • Progression-Free Survival (PFS) Determined Using RECIST v1.1
  • Percentage of Participants with Objective Response Determined Using Modified RECIST
  • DOR Determined Using Modified RECIST
  • PFS Determined Using Modified RECIST
  • Overall Survival (OS)

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