Atezolizumab in Treating Patients With Cancer Following Adoptive Cell Transfer
Last updated on July 2021Recruitment
- 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