Phase I Biomarker Study (BMS-936558)

Completed · Phase 1

Conditions studied: Renal Cell Carcinoma

In brief

The purpose of this study is to evaluate the pharmacodynamic and biologic properties of BMS-936558 in subjects with metastatic renal cell carcinoma.

Key facts

Study ID

NCT01358721

Run by

Bristol-Myers Squibb

People needed

119

Starts

2011-09-23

Expected to finish

2019-05-22

Last updated by the study team

2021-10-28

Who can join

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

You may qualify if…

• Women and men ≥ 18 years of age.
• Histologic confirmation of renal cell carcinoma with a clear cell component.
• Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST).
• Tumor sites that can be accessed for repeat biopsies at acceptable clinical risk.
• Previously treated subjects must have failed at least 1 prior anti-angiogenic agent and can have a maximum of 3 prior systemic treatments for renal cell cancer.
• Subjects in the treatment naive arm cannot have received prior systemic therapy for their renal cell carcinoma.

You may not qualify if…

• Active or progressing brain metastases.
• Active concomitant.
• Active or history of autoimmune disease.
• Active use of systemic corticosteroids.
• Prior therapy with Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA4), anti Programmed death-1 (anti-PD1), anti Programmed death ligand 1 (anti-PD-L1), anti Programmed death ligand 2 (anti-PD-L2), anti-CD137, anti-CD40, anti-OX40 antibodies.

Where it is running

• Ucsf Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• Yale University School Of Medicine — New Haven, Connecticut, United States
• H. Lee Moffitt Cancer Center — Tampa, Florida, United States
• University Of Chicago Medical Center — Chicago, Illinois, United States
• The Bunting-Blaustein Cancer Research Building — Baltimore, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Dana Farber Cancer Inst — Boston, Massachusetts, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Providence Portland Med Ctr — Portland, Oregon, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Upmc Cancer Pavilion — Pittsburgh, Pennsylvania, United States
• University Of Wisconsin Carbone Cancer Center — Madison, Wisconsin, United States
• Local Institution — Villejuif, France
• Local Institution — Pamplona, Spain

Full record on ClinicalTrials.gov

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