A Phase 1b Study of MDX-1106 in Subjects With Advanced or Recurrent Malignancies - Full Text View

Sponsor:	Bristol-Myers Squibb
Collaborator:	Ono Pharmaceutical Company, Ltd.
Information provided by (Responsible Party):	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00730639

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 I

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:

MedlinePlus related topics: Cancer Lung Cancer Melanoma

U.S. FDA Resources

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 ]

Estimated Enrollment:	290
Study Start Date:	October 2008
Estimated Study Completion Date:	October 2015
Estimated Primary Completion Date:	October 2015 (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

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

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

Locations

United States, Connecticut
Yale Comprehensive Cancer Center	Recruiting
New Haven, Connecticut, United States, 06520
Contact: Study Coordinator 203-785-2604
Principal Investigator: Mario Sznol, MD
United States, Maryland
John Hopkins University	Recruiting
Baltimore, Maryland, United States, 21231
Contact: Alice Pons ponsal@jhmi.edu
Principal Investigator: Julie Brahmer, MD
United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Study Coordinator 617-726-0605
Sub-Investigator: Donald P Lawrence, MD
Dana-Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Study Coordinator 617-582-7116
Principal Investigator: F. Stephen Hodi, MD
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Study Coordinator 617-632-9293
Sub-Investigator: David F. McDermott, MD
United States, Michigan
University of Michigan Comprehensive Cancer Center, Ravitz Phase 1 Center	Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Study Coordinator, BSN 734-615-6661
Principal Investigator: David C. Smith, MD
United States, New York
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Latisha Pace pacel@mskcc.org
Principal Investigator: Richard Carvajal, MD
United States, North Carolina
Carolina BioOncology Institute Cancer Therapy and Research Center	Recruiting
Huntersville, North Carolina, United States, 28078
Contact: Study Coordinator 704-947-6599
Principal Investigator: John Powderly, MD
United States, Ohio
The Christ Hospital	Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Kim Dissanayake kim.dissanayake@thechristhospital.com
Principal Investigator: Philip Leming, MD
United States, Tennessee
Vanderbilt-Ingram Cancer Center	Recruiting
Nashville, Tennessee, United States, 37232
Contact: Serena Rucker, RN Serena.rucker@vanderbilt.edu
Principal Investigator: Jeffrey Sosman, MD

Sponsors and Collaborators

Bristol-Myers Squibb

Ono Pharmaceutical Company, Ltd.

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00730639 History of Changes
Other Study ID Numbers:	MDX1106-03, CA209-003
Study First Received:	August 4, 2008
Last Updated:	October 19, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Non-Small-Cell Lung
Carcinoma, Renal Cell
Lung Neoplasms
Melanoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site

Lung Diseases
Respiratory Tract Diseases
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on February 12, 2012