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A Study of MDX-1106 in Patients With Selected Refractory or Relapsed Malignancies (MDX1106-01)

This study has been completed.
Information provided by:
Bristol-Myers Squibb Identifier:
First received: February 27, 2007
Last updated: April 22, 2010
Last verified: April 2010

February 27, 2007
April 22, 2010
August 2006
November 2009   (final data collection date for primary outcome measure)
incidence and severity of treatment-emergent adverse events [ Time Frame: if they occur, they will be monitored through resolution of the event ] [ Designated as safety issue: Yes ]
  • incidence and severity of treatment-emergent adverse events
  • vital sign measurements
  • clinical laboratory tests
  • physical examinations
  • electrocardiograms
Complete list of historical versions of study NCT00441337 on Archive Site
  • Clinical laboratory tests [ Time Frame: study duration ] [ Designated as safety issue: No ]
  • physical examination [ Time Frame: screening ] [ Designated as safety issue: No ]
  • electrocardiograms [ Time Frame: study completion ] [ Designated as safety issue: No ]
  • vital sign measurements [ Time Frame: study duration - each visit ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
A Study of MDX-1106 in Patients With Selected Refractory or Relapsed Malignancies
A Phase 1, Open Label, Dose-escalation, Safety and Pharmacokinetic Study of MDX-1106 in Patients With Selected or Relapsed Malignancies

To determine the safety and tolerability of MDX-1106 when administered to patients with advanced non-small cell lung cancer, colorectal cancer, malignant melanoma, renal clear cell cancer or hormone refractory prostate cancer

Six patients will be enrolled at each dose level of 0.3, 1.0, 3.0 and 10mg/kg; the remaining 10 to 15 patients may subsequently be enrolled at a dose at or below the maximum tolerated dose (MTD) during the dose-escalation portion of the study. Patients who respond may receive additional doses of drug.

Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Carcinoma, Non-Small-Cell Lung
  • Colorectal Cancer
  • Malignant Melanoma
  • Renal Cancer
  • Prostate Cancer
Biological: MDX-1106
patients will receive a single dose of MDX-1106 at 0.3, 1.0, 3.0 or 10 mg/kg as a 90 minute infusion.
Other Name: MDX-1106
Experimental: 1
patients will receive active MDX-1106 drug
Intervention: Biological: MDX-1106
George S, Pili R, Carducci MA, Kim JJ. Role of immunotherapy for renal cell cancer in 2011. J Natl Compr Canc Netw. 2011 Sep 1;9(9):1011-8. Review.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2009
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Relapsed/refractory non-small cell lung cancer, colorectal adenocarcinoma, malignant melanoma, renal (clear) cell carcinoma, or hormone-refractory prostate adenocarcinoma
  • Prior treatment must have been completed at least 4 weeks prior to enrollment
  • No untreated primary or metastatic brain or meningeal tumors
  • ECOG PS 0 or 1
  • Meet all screening laboratory values

Exclusion Criteria:

  • History of severe hypersensitivity reactions to other monoclonal antibodies
  • No active autoimmune disease or a documented history of autoimmune disease
  • No prior therapy with an anti-PD-1 or anti-CTLA-4 antibody
  • No active infection
  • No concomitant immunosuppressive medications
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
MDX1106-01, CA209-001
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
April 2010

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