Study of MDX-1203 in Subjects With Advanced/Recurrent Clear Cell Renal Cell Carcinoma (ccRCC) or Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (B-NHL)

Completed · Phase 1

Conditions studied: Renal Cell Carcinoma, Non-hodgkin's Lymphoma

In brief

The purpose of this study is to determine if MDX-1203 is safe for the treatment of renal cell carcinoma or non-hodgkin's lymphoma.

Key facts

Study ID

NCT00944905

Run by

Bristol-Myers Squibb

People needed

46

Starts

2009-07-01

Expected to finish

2012-11-01

Last updated by the study team

2013-05-22

Who can join

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

You may qualify if…

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
• Criteria specific to each tumor type:
• For Clear cell renal cell carcinoma (ccRCC): advanced or recurrent disease. Must have failed at least 1 prior systemic therapy
• For B-cell non-Hodgkin's lymphoma (B-NHL): Must have failed at least 1 prior systemic therapy
• Measurable disease criteria by tumor type:
• For ccRCC: At least 1 unidimensional measurable lesion
• For B-NHL: At least 1 bidimensionally measurable lesion
• Prior therapies for advanced/recurrent ccRCC or relapsed/refractory B-NHL or have become intolerant to a systemic therapy
• Provide archived or fresh tumor tissue for CD70 status. Subjects must be CD70+
• Provision of fresh tissue (pre-treatment and on-treatment) for exploratory analysis is mandatory for at least 5 and a maximum of 10 B-NHL subjects

You may not qualify if…

• Prior therapy with an anti-CD70 antibody
• History of severe hypersensitivity reactions to other monoclonal antibodies
• Active or untreated central nervous system lymphoma
• Active infection (viral, bacterial, or fungal)
• Evidence of bleeding diathesis or coagulopathy
• Active autoimmune disease requiring immunosuppressive therapy
• Known current drug or alcohol abuse

Where it is running

• Yale University School of Medicine — New Haven, Connecticut, United States
• Emory University Winship Cancer Center — Atlanta, Georgia, United States
• The University of Chicago — Chicago, Illinois, United States
• University of Maryland Greenebaum Cancer Center — Baltimore, Maryland, United States
• The University of Michigan Health System — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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