Multiple Ascending Dose (MDX1105-01) (Anti-PDL1)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00729664
First received: August 4, 2008
Last updated: March 28, 2013
Last verified: May 2012
  Purpose

Collection of survival data, evaluation of PDL-1 expression in tumors, and evaluation of PD-L1 receptor occupancy in peripheral blood has been added.


Condition Intervention Phase
Cancer, Multiple Indications
Biological: Anti-PDL-1 antibody
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Multidose Study of BMS-936559 (MDX-1105) Administered Every 14 Days in Subjects With Selected Advanced or Recurrent Solid Tumors

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Safety, maximum tolerated dose (MTD) and dose-limiting toxicity(DLT)of MDX-1105 [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
  • Safety, maximum tolerated dose (MTD) and dose-limiting toxicity(DLT)of MDX-1105 [ Time Frame: Bi-weekly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Preliminary efficacy in solid tumors on the basis of objective responses [ Time Frame: Day 42 ] [ Designated as safety issue: No ]

Estimated Enrollment: 286
Study Start Date: April 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anti-PDL-1 antibody (Arm 1)
BMS-936559 (MDX-1105)
Biological: Anti-PDL-1 antibody
Solution, Intravenous, 0.1 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
  • BMS-936559
  • MDX 1105
Experimental: Anti-PDL-1 antibody (Arm 2)
BMS-936559 (MDX-1105)
Biological: Anti-PDL-1 antibody
Solution, Intravenous, 0.3 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
  • BMS-936559
  • MDX 1105
Experimental: Anti-PDL-1 antibody (Arm 3)
BMS-936559 (MDX-1105)
Biological: Anti-PDL-1 antibody
Solution, Intravenous, 1 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
  • BMS-936559
  • MDX 1105
Experimental: Anti-PDL-1 antibody (Arm 4)
BMS-936559 (MDX-1105)
Biological: Anti-PDL-1 antibody
Solution, Intravenous, 3 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
  • BMS-936559
  • MDX 1105
Experimental: Anti-PDL-1 antibody (Arm 5)
BMS-936559 (MDX-1105)
Biological: Anti-PDL-1 antibody
Solution, Intravenous, 10 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
  • BMS-936559
  • MDX 1105

Detailed Description:

This is an open label, multicenter, dose escalation and multidose study of MDX-11-5, a fully human monoclonal IgG4 antibody targeting the Programed Death-Ligand 1 (PD-L1).

The study will consist of 3 periods: Screening (up to 28 days), Treatment (up to 16 six-week cycles), and Follow-up (up to 6 months).

  Eligibility

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

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1
  • The malignancies include relapsed/refractory renal cell carcinoma, non-small cell lung cancer, colorectal adenocarcinoma, malignant melanoma, advanced/metastatic epithelial ovarian cancer, gastric cancer, pancreatic cancer and breastcancer
  • Must have measurable disease

Exclusion Criteria:

  • Prior therapy with an anti-PD 1, anti-PDL 1, or anti-Cytotoxic T-Lymphocyte Antigen 4 antibody (or any other agents that target T-cell co-stimulation)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729664

Locations
United States, California
The Angeles Clinic & Research Institute
Los Angeles, California, United States, 90025
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
University Of Chicago
Chicago, Illinois, United States, 60637
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21231
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, Ohio
University Of Cincinnati
Cincinnati, Ohio, United States, 45267
Ohio State University
Columbus, Ohio, United States, 43210
United States, Texas
Oncology Consultants, Pa
Houston, Texas, United States, 77024
The University Of Texas
Houston, Texas, United States, 77030
United States, Washington
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
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: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00729664     History of Changes
Other Study ID Numbers: CA210-001, MDX1105-01
Study First Received: August 4, 2008
Last Updated: March 28, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014