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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.
Study NCT00730639   Information provided by Medarex
First Received: August 4, 2008   Last Updated: November 19, 2009   History of Changes

August 4, 2008
November 19, 2009
October 2008
November 2010   (final data collection date for primary outcome measure)
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 ]
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 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 ]
  • 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 ]
 
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.

 
Phase I
Interventional
Other, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
  • Metastatic Castration-resistant Prostrate Cancer (mCRPC)
  • Renal Cell Carcinoma (RCC)
  • Malignant Melanoma (MEL)
  • Non-small Cell Lung Cancer (NSCLC)
Biological: MDX-1106
Experimental: 3 cohorts
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
76
March 2011
November 2010   (final data collection date for primary outcome measure)

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;
Both
18 Years and older
No
 
United States
 
NCT00730639
Medarex Inc., Medarex Inc.
MDX1106-03
Medarex
 
Study Director: Medarex Medical Monitor Medarex
Medarex
November 2009

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