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

Status
Active
Cancer Type
Unknown Primary
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT02862275
Protocol IDs
10014 (primary)
10014
NCI-2016-01232
PJC-023
Study Sponsor
University Health Network Princess Margaret Cancer Center LAO

Summary

This pilot 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 tumor cells to grow and spread.

Objectives

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 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. 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.

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.
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