A Study of Atezolizumab (an Engineered Anti-Programmed Death-Ligand 1 [PDL1] Antibody) to Evaluate Safety, Tolerability and Pharmacokinetics in Participants With Locally Advanced or Metastatic Solid Tumors



Status:Completed
Conditions:Cancer, Cancer, Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/13/2018
Start Date:June 21, 2011
End Date:September 30, 2018

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A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Atezolizumab (MPDL3280A) Administered Intravenously as a Single Agent to Patients With Locally Advanced or Metastatic Solid Tumors or Hematologic Malignancies

This Phase I, multicenter, first-in-human, open-label, dose-escalation study will evaluate
the safety, tolerability, and pharmacokinetics of atezolizumab (MPDL3280A) administered as
single agent to participants with locally advanced or metastatic solid malignancies or
hematologic malignancies. The study will be conducted in two cohorts: Dose-escalation cohort
and Expansion cohort.


Inclusion Criteria:

- Participants who are 16 to 17 years old would be enrolled after consultation with the
Medical Monitor

- Histologically or cytologically documented, incurable or metastatic solid tumor or
hematologic malignancy that is advanced (non-resectable) or recurrent and progressing
since the last anti-tumor therapy and for which no recognized standard curative
therapy exists

- Representative tumor specimens in paraffin blocks (preferred) or at least 15 unstained
slides, with an associated pathology report

- Adequate hematologic and end organ function

- Measurable disease per RECIST v1.1 for participants with solid malignancies.
Disease-specific criteria for participants with prostate cancer, glioblastoma
multiforme (GBM), malignant lymphoma, or multiple myeloma

- For women of childbearing potential: agreement to remain abstinent or use
contraceptive methods

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- For participants who will undergo serial biopsy in dose-escalation cohort, baseline
tumor tissue samples should be of core needle biopsies for deep tumor tissue or organs
or excisional or punch biopsies for cutaneous or subcutaneous lesions (>/=5 millimeter
[mm] in diameter amenable to serial biopsy)

Exclusion Criteria:

- Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases

- Known hypersensitivity to pharmaceuticals produced in Chinese hamster ovary cells or
any component of the atezolizumab formulation

- History or risk of autoimmune disease (for example, systemic lupus erythematosus,
rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with
antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy,
Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis,
or glomerulonephritis)

- History of human immunodeficiency virus (HIV) infection, active hepatitis B (chronic
or acute), or hepatitis C infection

- Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1

- Malignancies other than disease under study within 5 years prior to Cycle 1, Day 1

- Participants with prior allogeneic bone marrow transplantation or prior solid organ
transplantation
We found this trial at
17
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Albany, New York 12206
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Baltimore, Maryland 21205
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450 Brookline Avenue
Boston, Massachusetts 02215
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5801 South Ellis Avenue
Chicago, Illinois 60637
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Chicago, IL
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9801 Kincey Avenue
Huntersville, North Carolina 28078
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3730 South Eastern Avenue
Las Vegas, Nevada 89169
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Los Angeles, California 90025
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Lyon, 69008
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Nashville, Tennessee 37203
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Nashville, Tennessee 37212
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333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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New Haven, CT
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5900 Lake Wright Dr
Norfolk, Virginia 23502
(757) 466-8683
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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Norfolk, VA
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8850 East Pima Center Parkway
Scottsdale, Arizona 85258
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291 Campus Drive
Stanford, California 94305
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Tampa, Florida 33612
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