A Phase 1 Study of MPDL3280A (an Engineered Anti-PDL1 Antibody) in Patients With Locally Advanced or Metastatic Solid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Genentech, Inc.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01375842
First received: June 16, 2011
Last updated: April 7, 2014
Last verified: April 2014

June 16, 2011
April 7, 2014
June 2011
April 2014   (final data collection date for primary outcome measure)
  • Incidence of dose limiting toxicities (DLTs) [ Time Frame: Up to day 21 ] [ Designated as safety issue: No ]
  • Nature of dose limiting toxicities (DLTs) [ Time Frame: Up to day 21 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01375842 on ClinicalTrials.gov Archive Site
  • Incidence of adverse events graded according to NCI CTCAE v4.0 [ Time Frame: Up to 90 days after the last dose of study treatment or until initiation of another anti cancer therapy, whichever occurs first ] [ Designated as safety issue: No ]
  • Nature of adverse events graded according to NCI CTCAE v4.0 [ Time Frame: Up to 90 days after the last dose of study treatment or until initiation of another anti cancer therapy, whichever occurs first ] [ Designated as safety issue: No ]
  • Severity of adverse events graded according to NCI CTCAE v4.0 [ Time Frame: Up to 90 days after the last dose of study treatment or until initiation of another anti cancer therapy, whichever occurs first ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Phase 1 Study of MPDL3280A (an Engineered Anti-PDL1 Antibody) in Patients With Locally Advanced or Metastatic Solid Tumors
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

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 or hematologic malignancies.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Cancers
Drug: MPDL3280A
Intravenous (IV) infusion repeating dose
Experimental: A
Intervention: Drug: MPDL3280A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
344
November 2016
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 disease-specific criteria for patients with hematologic malignancies
  • ECOG: 0-1

Exclusion Criteria:

  • Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases
  • History or risk 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
  • Malignancies other than disease under study within 5 years
  • Prior allogeneic stem cell transplant
Both
18 Years and older
No
Contact: Reference Study ID Number: PCD4989g www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
United States,   United Kingdom,   France,   Spain
 
NCT01375842
PCD4989g, GO27831
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP