Kidney Cancer Clinical Trial
Phase I Biomarker Study (BMS-936558)
Summary
The purpose of this study is to evaluate the pharmacodynamic and biologic properties of BMS-936558 in subjects with metastatic renal cell carcinoma.
Full Description
Intervention Model: Parallel Dose Comparison
Eligibility Criteria
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.
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There are 13 Locations for this study
San Francisco California, 94115, United States
New Haven Connecticut, 06520, United States
Tampa Florida, 33612, United States
Chicago Illinois, 60637, United States
Baltimore Maryland, 21231, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Durham North Carolina, 27710, United States
Portland Oregon, 97213, United States
Philadelphia Pennsylvania, 19111, United States
Pittsburgh Pennsylvania, 15232, United States
Madison Wisconsin, 53705, United States
Villejuif Cedex , 94805, France
Pamplona , 31192, Spain
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