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 pilot phase I trial studies the side effects of atezolizumab in treating patients with cancer following adoptive cell transfer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumour cells to grow and spread.

Trial Description

Primary Outcome:

• Incidence of adverse events

Secondary Outcome:

• 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
• Anti-tumour activity
• The response rate
• Survival outcomes
• Progression free survival
• Biomarker analysis

PRIMARY OBJECTIVE:

• To evaluate the safety of atezolizumab (MPDL3280A) administration in patients who have received adoptive cell transfer (ACT) prior to enrollment.

SECONDARY OBJECTIVES:

• To evaluate the expansion of engrafted T cells following atezolizumab administration in the peripheral blood and within the tumour microenvironment.
• To evaluate the phenotype and function of engrafted T cells following atezolizumab administration.
• To observe and record anti-tumour activity.
• 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.
• 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. Cycles 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