Study of the Safety and Pharmacokinetics of MPDL3280A Administered Intravenously As a Single Agent to 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 MPDL3280A administered as single agent by intravenous (IV) infusion to patients with locally advanced or metastatic solid 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: - Histologically or cytologically documented, incurable or metastatic solid malignancy that has failed to respond to all available standard therapy for which the patient is eligible or for which there is no standard therapy - Representative tumor specimens in paraffin blocks/unstained slides, with an associated pathology report - Adequate hematologic and end organ function - Measurable disease per RECIST - ECOG: 0-1 Exclusion Criteria: - Known primary central nervous system (CNS) malignancy or untreated or active CNS metastases - History of autoimmune disease (i.e. SLE, RA, inflammatory bowel disease, Type I DM, autoimmune thyroid disease, vasculitis, etc.) - History of HIV, hepatitis B, or hepatitis C infection - Any signs or symptoms of infection
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