Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Hematopoietic and Lymphoid Cell Neoplasm
  • Metastatic Malignant Solid Neoplasm
  • Unresectable Malignant Solid Neoplasm
Type
Interventional
Phase
Phase 1
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 bloo...

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

Tracking Information

NCT #
NCT02862275
Collaborators
Not Provided
Investigators
Principal Investigator: Marcus O Butler University Health Network Princess Margaret Cancer Center LAO