NCT02862275

Atezolizumab in Treating Patients With Cancer Following Adoptive Cell Transfer

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Atezolizumab	Given IV
PROCEDURE	Biopsy Procedure	Undergo tissue biopsy
PROCEDURE	Biospecimen Collection	Undergo blood specimen collection
PROCEDURE	Computed Tomography	Undergo CT scan
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI

Timeline

• Start date: 2017-05-24
• Primary completion: 2026-11-21
• Completion: 2026-11-21
• First posted: 2016-08-11
• Last updated: 2025-10-23

Locations

9 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study