Atezolizumab in Treating Patients with Cancer following Adoptive Cell Transfer

Active:	No
Cancer Type:	Hematopoietic Malignancies	NCT ID:	NCT02862275
Trial Phases:	Phase I	Protocol IDs:	10014 (primary) 10014 NCI-2016-01232 PJC-023
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	University Health Network Princess Margaret Cancer Center LAO
NCI Full Details:	http://clinicaltrials.gov/show/NCT02862275

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.

Objectives

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.

Treatment Sites in Georgia

Emory Saint Joseph's Hospital
5665 Peachtree Dunwoody Road NE
Atlanta, GA 30342
www.emoryhealthcare.org

Emory University Hospital - Atlanta
1364 Clifton Road NE
Atlanta, GA 30322
www.emoryhealthcare.org

Emory University Hospital - Midtown
550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.