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A Phase 1b Study of MDX-1106 in Subjects With Advanced or Recurrent Malignancies (MDX1106-03)
This study is currently recruiting participants.
Verified by Medarex, November 2009
First Received: August 4, 2008   Last Updated: November 19, 2009   History of Changes
Sponsor: Medarex
Information provided by: Medarex
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)
Malignant Melanoma (MEL)
Non-small Cell Lung Cancer (NSCLC)
Biological: MDX-1106
Phase I

Study Type: Interventional
Study Design: Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
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 Medarex:

Primary Outcome Measures:
  • To characterize the safety and tolerability of multiple doses of MDX-1106 [ Time Frame: Up to 12 eight (8) week cycles ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immunogenicity and PK of multiple doses [ Time Frame: up to 12 eight (8) week cycles ] [ Designated as safety issue: No ]
  • Assess the efficacy of MDX-1106 as monotherapy [ Time Frame: up to 12 eight (8) week cycles ] [ Designated as safety issue: No ]

Estimated Enrollment: 76
Study Start Date: October 2008
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Dose Escalating cohort: Experimental
3 cohorts
Biological: MDX-1106
MDX-1106 iv infusion, at selected dose every 2 weeks for a total of 4 doses, up to 12 eight (8) week cycles

  Eligibility

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

Inclusion Criteria:

  1. Subjects must have mCRPC,RCC, MEL, or NSCLC, that is advanced (non-resectable), or recurrent and for which no alternative, curative standard exists.
  2. ECOG Performance Status of 0-2
  3. Must have at least 1 measurable lesion
  4. Subjects with mCRPC and with only non-measurable bone lesions must have either progression new lesions or have PSA progression within the 6-week period before study administration
  5. At least 1 and up to 5 prior systemic therapies for advanced/recurrent disease
  6. Prior treated brain or meningeal metastases must be without 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
  7. 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.
  8. Immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids must be discontinued at least 2 weeks before study drug administration
  9. 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:

  1. History of severe hypersensitivity reactions to other mAbs;
  2. 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;
  3. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody (or any other antibody targeting T cell co-stimulation pathways);
  4. Known history of Human Immunodeficiency Virus;
  5. Active infection requiring therapy, positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA);
  6. Underlying medical conditions that will make the administration of study drug hazardous
  7. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids;
  8. 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
Medarex
Investigators
Study Director: Medarex Medical Monitor Medarex
  More Information

No publications provided

Responsible Party: Medarex Inc. ( Medarex Inc. )
Study ID Numbers: MDX1106-03
Study First Received: August 4, 2008
Last Updated: November 19, 2009
ClinicalTrials.gov Identifier: NCT00730639     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Urogenital Neoplasms
Urologic Neoplasms
Neuroendocrine Tumors
Carcinoma
Melanoma
Neuroectodermal Tumors
Neoplasms
Neoplasms by Site
Urologic Diseases
Respiratory Tract Diseases
Kidney Neoplasms
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Lung Diseases
Carcinoma, Renal Cell
Nevi and Melanomas
Kidney Diseases
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 20, 2009