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.

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Full Description

Intervention Model: Parallel Dose Comparison

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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.

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

119

Study ID:

NCT01358721

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 13 Locations for this study

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Ucsf Helen Diller Family Comprehensive Cancer Center
San Francisco California, 94115, United States
Yale University School Of Medicine
New Haven Connecticut, 06520, United States
H. Lee Moffitt Cancer Center
Tampa Florida, 33612, United States
University Of Chicago Medical Center
Chicago Illinois, 60637, United States
The Bunting-Blaustein Cancer Research Building
Baltimore Maryland, 21231, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Dana Farber Cancer Inst
Boston Massachusetts, 02215, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Providence Portland Med Ctr
Portland Oregon, 97213, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Upmc Cancer Pavilion
Pittsburgh Pennsylvania, 15232, United States
University Of Wisconsin Carbone Cancer Center
Madison Wisconsin, 53705, United States
Local Institution
Villejuif Cedex , 94805, France
Local Institution
Pamplona , 31192, Spain

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

119

Study ID:

NCT01358721

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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