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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00729664
First received: August 4, 2008
Last updated: September 3, 2015
Last verified: September 2015
August 4, 2008
September 3, 2015
February 2009
July 2015   (Final data collection date for primary outcome measure)
  • 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 ]
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 ]
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 ]
Evaluate preliminary efficacy in solid tumors on the basis of objective responses [ Time Frame: Days 1, 15 and 29 ]
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
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. 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.
 
Completed
281
July 2015
July 2015   (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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00729664
CA210-001
MDX1105-01 ( Other Identifier: BMS )
No
Not Provided
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
September 2015

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