Atezolizumab in Treating Patients With Cancer Following Adoptive Cell Transfer

NCT02862275 | Active Not Recruiting Phase 1 FDA Drug

• 4 other identifiers: NCI-2016-01232PJC-02310014UM1CA186644
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 9

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Will be assessed according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.0 (CTCAE version 5.0 will be used starting 04/01/2018). Adverse experiences will be graded and recorded throughout the study and during the follow-up period.

  Up to 6 weeks

Secondary Outcomes (7)

• Expansion of engrafted T cells following atezolizumab administration in the peripheral blood and within the tumor microenvironment

  Up to 1 year

• Phenotype and function of engrafted T cells following atezolizumab administration

  Up to 1 year

• Anti-tumor activity

  Up to 1 year

• The response rate

  Up to 1 year

• Survival outcomes

  Up to 1 year

Study Arms (1)

Treatment (atezolizumab)

EXPERIMENTAL

Patients receive atezolizumab 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 CT, MRI, and biopsy on study. Patients also undergo blood sample collection on study.

Drug: Atezolizumab; Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Laboratory Biomarker Analysis; Procedure: Magnetic Resonance Imaging

Interventions

Atezolizumab DRUG

Given IV

Also known as: MPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A, MPDL328OA, RG 7446, RG-7446, RG7446, RO 5541267, RO-5541267, RO5541267, Tecentriq

Treatment (atezolizumab)

Biopsy Procedure PROCEDURE

Undergo tissue biopsy

Also known as: Biopsy, BIOPSY_TYPE, Bx

Treatment (atezolizumab)

Biospecimen Collection PROCEDURE

Undergo blood specimen collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (atezolizumab)

Computed Tomography PROCEDURE

Undergo CT scan

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

Treatment (atezolizumab)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (atezolizumab)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Treatment (atezolizumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or pathologically confirmed malignancy (hematologic or solid tumor) that is metastatic or unresectable and for which standard of care therapy does not exist or is no longer effective
• ACT infusion prior to study enrollment (cohorts include ACT with tumor infiltrating lymphocytes \[TIL\], human leukocyte antigen \[HLA\]-class I T cell receptor \[TCR\]-engineered lymphocytes, HLA-class II TCR-engineered lymphocytes, and chimeric antigen receptor \[CAR\]-engineered T cells)
• Prior ACT therapy should be completed, and residual disease documented by either radiographic progression or active disease observed on biopsy (i.e. hematologic or solid tumor malignancy must be deemed active by the treating investigator); the investigator may deem that the disease is active on the basis of a pre-treatment biopsy demonstrating viable tumor cells or clinical progression of disease (i.e. RECIST progression is not required)
• Solid tumor patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>= 20 mm (\>= 2 cm) with conventional techniques or as \>= 15 mm (\>= 1.5 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
• Leukemia and non-Hodgkin's lymphoma patients must have measurable disease according to the revised response criteria for malignant lymphoma
• Disease suitable for assessment by pre- and post-biopsies
• There is no limit to the number of lines of prior therapy; prior anti-programmed cell death (PD)-1 or anti-PD-ligand (L)1 therapy and other immunotherapies are allowed
• Prior anti-PD-1 or anti-PD-L1 therapy may not be administered after ACT and before study atezolizumab (MPDL3280A) administration
• All ACT related toxicities resolved to grade 1 with the exception of alopecia, vitiligo and endocrine abnormalities requiring replacement therapy which may be grade 2
• No prior other anti-cancer therapy, including ACT, for 28 days prior to study administration of atezolizumab
• Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of atezolizumab in patients \< 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
• Life expectancy of greater than 3 months
• Absolute neutrophil count \>= 1,000/mcL
• Platelets \>= 75,000/mcL (\>= 50,000 for patients with hematologic malignancies)

You may not qualify if:

• Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (other than alopecia) due to agents administered more than 4 weeks earlier; however, the following therapies are allowed:
• Hormone-replacement therapy or oral contraceptives
• Herbal therapy \> 1 week prior to cycle 1, day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to cycle 1, day 1)
• Palliative radiotherapy for bone metastases \> 2 weeks prior to cycle 1, day 1
• Patients who have received prior treatment with anti-CTLA-4 antibody may be enrolled, provided the following requirements are met:
• \> 6 weeks from the last dose
• No history of severe immune-related adverse effects from anti-CTLA-4 antibody (National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] grade 3 and 4)
• Treatment with any other investigational agent within 4 weeks prior to cycle 1, day 1
• Treatment with systemic immunostimulatory agents (including, but not limited to, interferon \[IFN\]-alpha or interleukin \[IL\]-2) within 6 weeks prior to cycle 1, day 1
• Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[anti-TNF\] agents) within 2 weeks prior to cycle 1, day 1
• Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea, premedication for a radiologic contrast allergy) may be enrolled
• The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
• Patients who receive low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed
• Patients taking bisphosphonate therapy for symptomatic hypercalcemia; use of bisphosphonate therapy for other reasons (e.g., bone metastasis or osteoporosis) is allowed
• Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded, with the following exceptions:

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (9)

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

Moffitt Cancer Center-International Plaza

Tampa, Florida, 33607, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Neoplasm Metastasis

Interventions

atezolizumab; Biopsy; Specimen Handling; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Marcus O Butler

  University Health Network Princess Margaret Cancer Center LAO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 11, 2016
• Study Start: May 24, 2017
• Primary Completion (Estimated): November 21, 2026
• Study Completion (Estimated): November 21, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

US (8); CA (1)