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Clinical Trial VICCPHI1138


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

Principal Investigator(s)

Jordan Berlin


  • Protocol No. VICCPHI1138
  • Open Date: 03/08/2012
  • Staging: Phase I
  • Age Group: Adults
  • Scope: National
  • Objective: To evaluate the safety and tolerability of MPDL3280A administered by IV infusion every 3 weeks (q3w) to patients with locally advanced or metastatic solid tumors or hemtologic malignancies To determine the maximum tolerated dose (MTD) and to evaluate the dose-limiting toxicities (DLTs) of MPDL3280A when administered as a single agent to patients by IV infusion q3w To identify a recommended Phase II dose of MPDL3280A
  • Disease Sites: Phase I
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: MPDL3280A
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01375842
  • Secondary Protocol No: PCD4989g


Patients are asked to take part in this research study because they have cancer that is locally advanced or metastatic solid tumors (cancer that has grown or spread) that did not respond to previous treatment(s) or for which previous treatment(s) were stopped because the side effects were not tolerable or you have non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM). Genentech is the Sponsor of this research study. Genentech will pay the study center to cover the study center's costs of conducting this research study. The purpose of this study is to test the safety of an investigational drug (MPDL3280A) in patients with locally advanced or metastatic solid tumors, NHL or MM at different dose levels. We also want to find out the best dose of MPDL3280A and what effects, good and/or bad, it has on tumors. Blood or tissue samples and related medical information collected during this study will be used by Genentech researchers and other researchers partnering with Genentech for research related to solid tumors, NHL and MM or how MPDL3280A works. Samples of blood or tissue may be used by researchers to learn more about how to predict response to treatment. Research on how MPLD3280A works may help develop new treatments or diagnostic tests in the future. Results from this research will be based on information from all of the patients who take part in this study and not just from one patient's samples. The use of MPDL3280A in this research study is investigational, which means that it is not yet approved by the U.S. Food and Drug Administration (FDA) for cancer treatment or any other disease. MPDL3280A has not been used in humans before. Participation is voluntary.


Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No


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