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
Phase:
Diagnosis: Cutaneous Skin Cancer
NCT ID: NCT01375842
(View complete trial on ClinicalTrials.gov)
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
Contacts:
Beth-Israel Deaconess Medical Center:
Cancer Trials Call Center, 617-667-3060
Dana-Farber Cancer Institute:
Suzanne MacRae, 617-632-5906,
smacrae@partners.org
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