A Phase 1b Study of MDX-1106 in Subjects With Advanced or Recurrent Malignancies (MDX1106-03)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ono Pharmaceutical Company, Ltd.
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00730639
First received: August 4, 2008
Last updated: October 13, 2014
Last verified: May 2014

August 4, 2008
October 13, 2014
January 2009
February 2013   (final data collection date for primary outcome measure)
To characterize the safety and tolerability of multiple doses of BMS-936558 (MDX-1106) [ Time Frame: 70 days post last dose of study drug ] [ Designated as safety issue: Yes ]
To characterize the safety and tolerability of multiple doses of MDX-1106 [ Time Frame: Up to 12 eight (8) week cycles, each cycle is comprised of 4 doses, on days 1,15,29,and 43 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00730639 on ClinicalTrials.gov Archive Site
  • Immunogenicity of multiple doses of BMS-936558 [ Time Frame: up to 12 eight (8) week cycles ] [ Designated as safety issue: No ]
  • Pharmacokinetic (PK) profile of multiple doses of BMS-936558 [ Time Frame: Samples collection for PK analysis through Cycle 3 (first 24 weeks) of study therapy. ] [ Designated as safety issue: No ]
  • Assess the efficacy of BMS-936558 (MDX-1106) as monotherapy [ Time Frame: Every 8 weeks throughout study participation. ] [ Designated as safety issue: No ]
  • The dose response relationship in melanoma and in NSCLC [ Time Frame: 56 of each cycle (up to cycle 18) and if available including off-study and follow-up visits (approximately up to 46 weeks) ] [ Designated as safety issue: No ]
  • Measures of humoral and cellular immune responses to tumor antigens and recall responses to non-tumor antigens such as T cell reactivity against melanoma peptides [ Time Frame: Day 1 of each cycle (up to cycle 18) and if available including off-study and follow-up visits (approximately up to 46 weeks) ] [ Designated as safety issue: No ]
    These will be measured only at selected study sites and for subsets of selected tumors, and are very exploratory in nature
  • Immunogenicity and PK of multiple doses [ Time Frame: up to 12 eight week cycles ] [ Designated as safety issue: No ]
  • Assess the efficacy of MDX-1106 as monotherapy [ Time Frame: up to 12 eight week cycles ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Phase 1b Study of MDX-1106 in Subjects With Advanced or Recurrent Malignancies
A Phase 1b, Open-label, Multicenter, Multidose, Dose-escalation Study of MDX-1106 in Subjects With Selected Advanced or Recurrent Malignancies

The purpose of this study is to determine the safety and effectiveness of MDX-1106 in patients with certain types of cancer. Another purpose is to determine how MDX-1106 is absorbed and distributed within the body, and how it's eventually eliminated.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Metastatic Castration-resistant Prostrate Cancer (mCRPC)
  • Renal Cell Carcinoma (RCC)
  • Metastatic Melanoma (MEL)
  • Non-small Cell Lung Cancer (NSCLC)
  • Biological: BMS-936558 (MDX-1106)
    Solution, Intravenous, 0.1 mg/kg - 10 mg/kg, Every 2 weeks, 3 years depending on response
    Other Name: BMS-936558
  • Biological: BMS-936558 (MDX-1106)
    Solution, Intravenous, 1 - 10 mg/kg, Every 2 weeks, 3 years depending on response
    Other Name: BMS-936558
  • Biological: BMS-936558 (MDX-1106)
    Solution, Intravenous, 10 mg/kg, Every 2 weeks, 3 years depending on response
    Other Name: BMS-936558
  • Experimental: Melanoma - BMS-936558 (MDX-1106)
    Intervention: Biological: BMS-936558 (MDX-1106)
  • Experimental: RCC - BMS-936558 (MDX-1106)
    Intervention: Biological: BMS-936558 (MDX-1106)
  • Experimental: mCRPC - BMS-936558 (MDX-1106)
    Intervention: Biological: BMS-936558 (MDX-1106)
  • Experimental: NSCLC - BMS-936558 (MDX-1106)
    Intervention: Biological: BMS-936558 (MDX-1106)
  • Experimental: CRC - BMS-936558 (MDX-1106)
    Intervention: Biological: BMS-936558 (MDX-1106)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
311
June 2015
February 2013   (final data collection date for primary outcome measure)

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Subjects must have mCRPC,RCC, MEL, Non-small-cell lung cancer (NSCLC), or Colorectal Cancer (CRC), that is advanced (non-resectable), or recurrent and for which no alternative, curative standard exists
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
  • Must have at least 1 measurable lesion
  • Subjects with mCRPC and with only non-measurable bone lesions must have either progression new lesions or have Prostate-specific antigen (PSA) progression within the 6-week period before study administration
  • At least 1 and up to 5 prior systemic therapies for advanced/recurrent disease
  • Prior treated brain or meningeal metastases must be without Magnetic resonance imaging (MRI) evidence of progression for at least 8 weeks and off immunosuppressive doses of systemic steroids for at least 2 weeks before study drug administration
  • Prior systemic radiation therapy must have been completed at least 4 weeks before study drug administration. Prior focal radiotherapy completed at least 2 weeks prior to study drug administration
  • Immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids must be discontinued at least 2 weeks before study drug administration
  • Prior surgery that required general anesthesia must be completed at least 2 weeks before study drug administration. Surgery requiring local/epidural anesthesia must be completed at least 72 hours before study drug administration

Exclusion Criteria:

  • History of severe hypersensitivity reactions to other Monoclonal antibody (mAb)s
  • Subjects with any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, except for subjects with vitiligo or resolved childhood asthma/atopy
  • Prior therapy with an anti-Programmed death-1 (PD-1), anti-PD-L1, anti-PDL-2, or anti- Cytotoxic t-lymphocyte antigen-4 (CTLA-4) antibody (or any other antibody targeting T cell co-stimulation pathways)
  • Known history of Human Immunodeficiency Virus
  • Active infection requiring therapy, positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA)
  • Underlying medical conditions that will make the administration of study drug hazardous
  • Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids
  • Use of other investigational drugs (drugs not marketed for any indication) within 28 days or at least 5 half-lives (whichever is longer) before study drug administration
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00730639
CA209-003, MDX1106-03
Yes
Bristol-Myers Squibb
Bristol-Myers Squibb
Ono Pharmaceutical Company, Ltd.
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
May 2014

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