| 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 |
| |
| |
| Recruiting |
| 76 |
| March 2011 |
| November 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Subjects must have mCRPC,RCC, MEL, or NSCLC, that is advanced (non-resectable), or recurrent and for which no alternative, curative standard exists.
- 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 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 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 mAbs;
- 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-PD-1, anti-PD-L1, anti-PDL-2, or anti-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 |
|
| United States |
| |
| NCT00730639 |
| Medarex Inc., Medarex Inc. |
| MDX1106-03 |
| Medarex |
|
| Study Director: |
Medarex Medical Monitor |
Medarex |
|
|
| Medarex |
| November 2009 |