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A Phase 1 Study of Atezolizumab (an Engineered Anti-PDL1 Antibody) in Patients With Locally Advanced or Metastatic Solid Tumors

Status: Recruiting
Diagnosis: Melanoma
NCT ID: NCT01375842 (View complete trial on
DFCI Protocol ID: 11-314


This Phase I, multicenter, first in human, open-label, dose escalation study will evaluate the safety, tolerability, and pharmacokinetics of Atezolizumab administered as single agent by intravenous (IV) infusion to patients with locally advanced or metastatic solid malignancies or hematologic malignancies.


Conducting Institutions:
Beth-Israel Deaconess Medical Center, Dana-Farber Cancer Institute, Massachusetts General Hospital

Overall PI:
Frank Stephen Hodi, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Daniel Cho, MD, Beth Israel Deaconess Medical Center
Donald Lawrence, MD, Massachusetts General Hospital

Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060
Dana-Farber Cancer Institute: Janice Russell,
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Age >/=18 years, patients who are <18 years old may be enrolled after consultation with the Medical Monitor - Histologically or cytologically documented, incurable or metastatic solid tumor or hematologic malignancy - Representative tumor specimens in paraffin blocks/unstained slides, with an associated pathology report - Adequate hematologic and end organ function - Measurable disease per RECIST for patients with solid malignancies or per protocol-specified disease-specific criteria for patients with prostate cancer, glioblastoma multiforme (GBM), malignant lymphoma, or multiple myeloma - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: - Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases - History or risk of autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, vasculitis, etc.) - History of HIV, hepatitis B, or hepatitis C infection - Any signs or symptoms of infection - Malignancies other than disease under study within 5 years - Prior allogeneic stem cell transplant
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