A Dose-Escalation Study of the Safety and Pharmacokinetics of MOXR0916 and Atezolizumab With or Without Bevacizumab 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 With or Without Bevacizumab 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 with or without bevacizumab 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.

Trial Description

Primary Outcome:

  • Incidence of dose-limiting toxicities (DLTs)
  • Incidence of adverse events graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0
Secondary Outcome:
  • Maximum tolerated dose (MTD)
  • Pharmacokinetic parameters derived from serum MOXR0916 and serum atezolizumab concentrations: area under the concentration-time curve (AUC), maximum and minimum serum concentrations (Cmax and Cmin), clearance and volume of distribution at steady state
  • Overall survival (OS) determined as the time from first study treatment to death from any cause
  • Incidence of anti-MOXR0916, anti-atezolizumab, and anti-bevacizumab antibodies
  • Percentage of participants with objective response complete respons (CR) or partial response (PR) determined using RECIST v.1.1
  • Duration of response determined using RECIST v.1.1
  • Progression-free survival (PFS) determined using RECIST v.1.1

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.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society