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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00729664
Recruitment Status : Completed
First Posted : August 7, 2008
Last Update Posted : September 7, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE August 4, 2008
First Posted Date  ICMJE August 7, 2008
Last Update Posted Date September 7, 2015
Study Start Date  ICMJE February 2009
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2012)
  • Safety, maximum tolerated dose (MTD) and dose-limiting toxicity(DLT)of MDX-1105 [ Time Frame: Weekly ]
  • Safety, maximum tolerated dose (MTD) and dose-limiting toxicity(DLT)of MDX-1105 [ Time Frame: Bi-weekly ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 4, 2008)		 To determine the safety, maximum tolerated dose(MTD and dose-limiting toxicity(DLT)of MDX-1105 [ Time Frame: MDX-1105 administered as an infusion every 14 days for a total of 3 infusions ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2012)		 Preliminary efficacy in solid tumors on the basis of objective responses [ Time Frame: Day 42 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2008)		 Evaluate preliminary efficacy in solid tumors on the basis of objective responses [ Time Frame: Days 1, 15 and 29 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multiple Ascending Dose (MDX1105-01)
Official Title  ICMJE A Phase 1, Multidose Study of BMS-936559 (MDX-1105) Administered Every 14 Days in Subjects With Selected Advanced or Recurrent Solid Tumors
Brief Summary Collection of survival data, evaluation of PDL-1 expression in tumors, and evaluation of PD-L1 receptor occupancy in peripheral blood has been added.
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cancer, Multiple Indications
Intervention  ICMJE
  • 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
  • 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
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Anti-PDL-1 antibody (Arm 1)
    BMS-936559 (MDX-1105)
    Intervention: Biological: Anti-PDL-1 antibody
  • Experimental: Anti-PDL-1 antibody (Arm 2)
    BMS-936559 (MDX-1105)
    Intervention: Biological: Anti-PDL-1 antibody
  • Experimental: Anti-PDL-1 antibody (Arm 3)
    BMS-936559 (MDX-1105)
    Intervention: Biological: Anti-PDL-1 antibody
  • Experimental: Anti-PDL-1 antibody (Arm 4)
    BMS-936559 (MDX-1105)
    Intervention: Biological: Anti-PDL-1 antibody
  • Experimental: Anti-PDL-1 antibody (Arm 5)
    BMS-936559 (MDX-1105)
    Intervention: Biological: Anti-PDL-1 antibody
Publications * Brahmer JR, Tykodi SS, Chow LQ, Hwu WJ, Topalian SL, Hwu P, Drake CG, Camacho LH, Kauh J, Odunsi K, Pitot HC, Hamid O, Bhatia S, Martins R, Eaton K, Chen S, Salay TM, Alaparthy S, Grosso JF, Korman AJ, Parker SM, Agrawal S, Goldberg SM, Pardoll DM, Gupta A, Wigginton JM. Safety and activity of anti-PD-L1 antibody in patients with advanced cancer. N Engl J Med. 2012 Jun 28;366(26):2455-65. doi: 10.1056/NEJMoa1200694. Epub 2012 Jun 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 3, 2015)		 281
Original Estimated Enrollment  ICMJE
 (submitted: August 4, 2008)		 40
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00729664
Other Study ID Numbers  ICMJE CA210-001
MDX1105-01 ( Other Identifier: BMS )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Bristol-Myers Squibb
Original Responsible Party Merarex Inc., Medarex Inc.
Current Study Sponsor  ICMJE Bristol-Myers Squibb
Original Study Sponsor  ICMJE Medarex
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date September 2015

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