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: September 15, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Metastatic Castration-resistant Prostrate Cancer (mCRPC)
Renal Cell Carcinoma (RCC)
Metastatic Melanoma (MEL)
Non-small Cell Lung Cancer (NSCLC)
Biological: BMS-936558 (MDX-1106)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1b, Open-label, Multicenter, Multidose, Dose-escalation Study of MDX-1106 in Subjects With Selected Advanced or Recurrent Malignancies

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 311
Study Start Date: January 2009
Estimated Study Completion Date: June 2015
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Melanoma - BMS-936558 (MDX-1106) 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
Experimental: RCC - BMS-936558 (MDX-1106) Biological: BMS-936558 (MDX-1106)
Solution, Intravenous, 1 - 10 mg/kg, Every 2 weeks, 3 years depending on response
Other Name: BMS-936558
Experimental: mCRPC - BMS-936558 (MDX-1106) Biological: BMS-936558 (MDX-1106)
Solution, Intravenous, 10 mg/kg, Every 2 weeks, 3 years depending on response
Other Name: BMS-936558
Experimental: NSCLC - BMS-936558 (MDX-1106) Biological: BMS-936558 (MDX-1106)
Solution, Intravenous, 1 - 10 mg/kg, Every 2 weeks, 3 years depending on response
Other Name: BMS-936558
Experimental: CRC - BMS-936558 (MDX-1106) Biological: BMS-936558 (MDX-1106)
Solution, Intravenous, 10 mg/kg, Every 2 weeks, 3 years depending on response
Other Name: BMS-936558

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730639

Locations
United States, Arizona
Pinnacle Oncology Hematology
Scottsdale, Arizona, United States, 85258
United States, Connecticut
Yale University School Of Medicine
New Haven, Connecticut, United States, 06520
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
University Of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Carolina Biooncology Institute
Huntersville, North Carolina, United States, 28078
United States, Ohio
Christ Hospital
Cincinnati, Ohio, United States, 45219
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Vanderbilt-Ingram Cancer Ctr
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Company, Ltd.
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: NCT00730639     History of Changes
Other Study ID Numbers: CA209-003, MDX1106-03
Study First Received: August 4, 2008
Last Updated: September 15, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Renal Cell
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 16, 2014