Moffitt Cancer Center: Clinical Trial 19158

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Clinical Trial 19158

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT02862275

Phase: Early Phase I
Prinicipal Investigator: Frederick Locke

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

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

Summary

This 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.

Objective

-To evaluate the safety of atezolizumab (MPDL3280A) administration in patients who have received ACT within 6 months of enrollment. -To evaluate the expansion of engrafted T cells following atezolizumab administration in the peripheral blood and within the tumor microenvironment. -To evaluate the phenotype and function of engrafted T cells following atezolizumab administration. -To observe and record anti-tumor activity. To evaluate the response rate using irRC and RECIST v1.1, or other tumor-specific criteria. -To evaluate survival outcomes and progression free survival using irRC and RECIST v1.1, or other tumor-specific criteria.

Treatments

Therapies

Medications

Atezolizumab (Tecentriq)

Inclusion Criteria

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

Prior ACT infusion within 6 months of 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 >= 10 mm (>= 1 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

Eastern Cooperative Oncology Group (ECOG) performance status equal to or less than 2

Life expectancy of greater than 3 months

Adequate hepatic, renal and bone marrow function

International normalized ratio (INR) and activated partial thromboplastin time (aPTT) equal to or less than 1.5 x upper limit of normal (ULN) (this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose)

Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 5 months (150 days) after the last dose of study agent

Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

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; 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 additional specific criteria are met

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 may be enrolled. The use of inhaled corticosteroids and mineralocorticoids 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 is allowed

Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded. Some exceptions apply

Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies

History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins

Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease

Patients with past or resolved hepatitis B infection may be eligible

Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)

History or risk of autoimmune disease that threatens vital organ function

History of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan; history of radiation pneumonitis in the radiation field is permitted

Active tuberculosis (TB)

Patients requiring treatment with a RANKL) who cannot discontinue it before treatment with atezolizumab

Severe infections within 4 weeks prior to cycle 1, day 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia

Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1

Received oral or intravenous (IV) antibiotics within 2 weeks prior to cycle 1, day 1; patients receiving prophylactic antibiotics are eligible

Major surgical procedure within 28 days prior to cycle 1, day 1 or anticipation of need for a major surgical procedure during the course of the study

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Patients positive for human immunodeficiency virus (HIV) are NOT excluded from this study; HIV-positive patients must meet additional criteria

Pregnant of breastfeeding

Additional criteria may apply

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.