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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00441337
First received: February 27, 2007
Last updated: April 22, 2010
Last verified: April 2010
  Purpose

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


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Colorectal Cancer
Malignant Melanoma
Renal Cancer
Prostate Cancer
Biological: MDX-1106
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Open Label, Dose-escalation, Safety and Pharmacokinetic Study of MDX-1106 in Patients With Selected or Relapsed Malignancies

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 39
Study Start Date: August 2006
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
patients will receive active MDX-1106 drug
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

Detailed Description:

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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441337

Locations
United States, Maryland
Johns Hopkins Unv., School of Medicine
Baltimore, Maryland, United States, 21231
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Missouri
Washington University School of Medicine - Barnes Jewish Hospital
St. Louis, Missouri, United States, 63110
United States, North Carolina
Carolina BioOncology Institute, PLLC
Huntersville, North Carolina, United States, 28078
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00441337     History of Changes
Other Study ID Numbers: MDX1106-01, CA209-001
Study First Received: February 27, 2007
Last Updated: April 22, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
malignancies
cancer
non small cell lung cancer
lung cancer
colorectal cancer
adenocarcinoma
melanoma
malignant melanoma
renal cancer
renal carcinoma
carcinoma
prostate cancer
prostate adenocarcinoma
Recurrent or treatment refractory malignancies

Additional relevant MeSH terms:
Prostatic Neoplasms
Melanoma
Colorectal Neoplasms
Neoplasms
Carcinoma
Carcinoma, Non-Small-Cell Lung
Carcinoma, Renal Cell
Kidney Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on September 30, 2014