Atezolizumab in Treating Patients With Cancer Following Adoptive Cell Transfer

Official Title

A Pilot Study of Atezolizumab (MPDL3280A) Following Adoptive Cell Transfer in Active Hematologic or Solid Tumour Malignancies

Summary:

This phase I trial studies the side effects of atezolizumab in treating patients with cancer following adoptive cell transfer. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumour cells to grow and spread.

Trial Description

Primary Outcome:

  • Incidence of adverse events according to NCI CTCAE v. 4.0
Secondary Outcome:
  • Anti-tumour activity
  • Biomarker analysis
  • Expansion of engrafted T cells following atezolizumab administration in the peripheral blood and within the tumour microenvironment
  • Phenotype and function of engrafted T cells following atezolizumab administration
  • Progression free survival using irRC and RECIST v1.1, or other tumour-specific criteria
  • Survival outcomes using irRC and RECIST v1.1, or other tumour-specific criteria
  • The response rate using irRC and RECIST v1.1, or other tumour-specific criteria
PRIMARY OBJECTIVES:
I. To evaluate the safety of atezolizumab (MPDL3280A) administration in patients who have received adoptive cell transfer (ACT) within 6 months of enrollment. SECONDARY OBJECTIVES:
I. To evaluate the expansion of engrafted T cells following atezolizumab administration in the peripheral blood and within the tumour microenvironment. II. To evaluate the phenotype and function of engrafted T cells following atezolizumab administration. III. To observe and record anti-tumour activity. IV. To evaluate the response rate using immune related Response Criteria (irRC) and Response Evaluation Criteria in Solid Tumours (RECIST) version (v)1.1, or other tumour-specific criteria. V. To evaluate survival outcomes and progression free survival using irRC and RECIST v1.1, or other tumour-specific criteria. OUTLINE:

Patients receive atezolizumab intravenously (IV) over 30- 60 minutes on day 1. Courses repeat every 21 days for a total of 17 doses over up to 12 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 4 weeks, 8 weeks, and then every 3 months thereafter.

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