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Trial record 1 of 2 for:    MDX-1105
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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
History of Changes

August 4, 2008
March 28, 2013
April 2009
December 2013   (final data collection date for primary outcome measure)
  • 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 ]
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 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00729664 on ClinicalTrials.gov Archive Site
Preliminary efficacy in solid tumors on the basis of objective responses [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
Evaluate preliminary efficacy in solid tumors on the basis of objective responses [ Time Frame: Days 1, 15 and 29 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Multiple Ascending Dose (MDX1105-01)
A Phase 1, Multidose Study of BMS-936559 (MDX-1105) Administered Every 14 Days in Subjects With Selected Advanced or Recurrent Solid Tumors

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

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).
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cancer, Multiple Indications
  • 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
  • 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
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. Epub 2012 Jun 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
286
December 2013
December 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00729664
CA210-001, MDX1105-01
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
May 2012

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