A Study of MDX-1106 in Patients With Selected Refractory or Relapsed Malignancies

Completed · Phase 1

Conditions studied: Carcinoma, Non-Small-Cell Lung, Colorectal Cancer, Malignant Melanoma, Renal Cancer, Prostate Cancer

In brief

To evaluate the safety, tolerability, efficacy, and pharmacokinetics of MDX-1106 when administered to patients with advanced non-small cell lung cancer, colorectal cancer, malignant melanoma, clear cell renal cell cancer or hormone refractory prostate cancer

Key facts

Study ID

NCT00441337

Run by

Bristol-Myers Squibb

People needed

39

Starts

2006-08-01

Expected to finish

2009-11-01

Last updated by the study team

2015-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Relapsed/refractory non-small cell lung cancer, colorectal adenocarcinoma, malignant melanoma, renal (clear) cell carcinoma, or hormone-refractory prostate adenocarcinoma
• Prior treatment must have been completed at least 4 weeks prior to enrollment
• No untreated primary or metastatic brain or meningeal tumors
• ECOG PS 0 or 1
• Meet all screening laboratory values

You may not qualify if…

• History of severe hypersensitivity reactions to other monoclonal antibodies
• Active autoimmune disease or a documented history of autoimmune disease
• Prior therapy with an anti-PD-1 or anti-CTLA-4 antibody
• Active infection
• Concurrent medical condition requiring the use of immunosuppressive medications

Where it is running

• Johns Hopkins Unv., School of Medicine — Baltimore, Maryland, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Washington University School of Medicine - Barnes Jewish Hospital — St Louis, Missouri, United States
• Carolina BioOncology Institute, PLLC — Huntersville, North Carolina, United States

Full record on ClinicalTrials.gov

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