Atezolizumab in Treating Patients With Cancer Following Adoptive Cell Transfer

Hematopoietic and Lymphoid Cell Neoplasm Clinical Trial

Official title: A Pilot Study of Atezolizumab (MPDL3280A) Following Adoptive Cell Transfer in Active Hematologic or Solid Tumor Malignancies

Status Active, not recruiting

Clinical Trial 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 tumor cells to grow and spread.

Clinical Trial Description

PRIMARY OBJECTIVE:

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

SECONDARY OBJECTIVES:

I. To evaluate the expansion of engrafted T cells following atezolizumab administration in the peripheral blood and within the tumor microenvironment.

II. To evaluate the phenotype and function of engrafted T cells following atezolizumab administration.

III. To observe and record anti-tumor activity. IV. To evaluate the response rate using immune related Response Criteria (irRC) and Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1, or other tumor-specific criteria.

V. To evaluate survival outcomes and progression free survival using irRC and RECIST v1.1, or other tumor-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. Patients undergo computed tomography (CT), magnetic resonance imaging (MRI), and biopsy on study. Patients also undergo blood sample collection on study.

After completion of study treatment, patients are followed up at 4 weeks, 8 weeks, and then every 3 months thereafter. ;

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid Cell Neoplasm
• Metastatic Malignant Solid Neoplasm
• Neoplasms
• Unresectable Malignant Solid Neoplasm

• NCT number: NCT02862275
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: May 24, 2017
• Completion date: November 21, 2024