Phase I Biomarker Study (BMS-936558)



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/24/2018
Start Date:August 11, 2011
End Date:November 16, 2018

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An Exploratory Study to Investigate the Immunomodulatory Activity of Various Dose Levels of Anti Programmed-Death-1 (PD-1) Antibody (BMS-936558) in Subjects With Metastatic Clear Cell Renal Cell Carcinoma (RCC).

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

Intervention Model: Parallel Dose Comparison

For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.
We found this trial at
13
sites
333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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Portland, OR
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1600 Divisadero Street
San Francisco, California 94115
888.689.8273
UCSF Helen Diller Family Comprehensive Cancer Center UCSF’s long tradition of excellence in cancer research...
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San Francisco, CA
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Baltimore, MD
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Boston, Massachusetts 02115
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Boston, MA
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Chicago, IL
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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600 Highland Ave.
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Carbone Cancer Center UW Carbone Cancer Center holds the unique distinction of...
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Madison, WI
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Philadelphia, Pennsylvania 19111
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Philadelphia, PA
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Pittsburgh, Pennsylvania 15232
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Tampa, Florida 33612
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Tampa, FL
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Villejuif Cedex, 94805
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Villejuif Cedex,
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