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 |
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.
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
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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4805 Northeast Glisan Street
Portland, Oregon 97213
Portland, Oregon 97213
(503) 215-1111
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Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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1600 Divisadero Street
San Francisco, California 94115
San Francisco, California 94115
888.689.8273
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UCSF Helen Diller Family Comprehensive Cancer Center UCSF’s long tradition of excellence in cancer research...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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600 Highland Ave.
Madison, Wisconsin 53792
Madison, Wisconsin 53792
(608) 263-6400
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University of Wisconsin Carbone Cancer Center UW Carbone Cancer Center holds the unique distinction of...
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Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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