Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE1
119 participants
INTERVENTIONAL
2011-09-23
2019-05-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Arm 1: BMS-936558
BMS-936558 (Anti-PD-1)
Solution, Intravenous infusion, 0.3 mg/kg, Every 3 weeks, Indefinitely depending on response
Arm 2: BMS-936558
BMS-936558 (Anti-PD-1)
Solution, Intravenous infusion, 2 mg/kg, Every 3 weeks, Indefinitely depending on response
Arm 3: BMS-936558
BMS-936558 (Anti-PD-1)
Solution, Intravenous infusion, 10 mg/kg, Every 3 weeks, Indefinitely depending on response
Arm 4: BMS-936558
(treatment naive)
BMS-936558 (Anti-PD-1)
Solution, Intravenous infusion, 10 mg/kg, Every 3 weeks, Indefinitely depending on response
Interventions
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BMS-936558 (Anti-PD-1)
Solution, Intravenous infusion, 0.3 mg/kg, Every 3 weeks, Indefinitely depending on response
BMS-936558 (Anti-PD-1)
Solution, Intravenous infusion, 2 mg/kg, Every 3 weeks, Indefinitely depending on response
BMS-936558 (Anti-PD-1)
Solution, Intravenous infusion, 10 mg/kg, Every 3 weeks, Indefinitely depending on response
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Ono Pharma USA Inc
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Countries
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References
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Ross-Macdonald P, Walsh AM, Chasalow SD, Ammar R, Papillon-Cavanagh S, Szabo PM, Choueiri TK, Sznol M, Wind-Rotolo M. Molecular correlates of response to nivolumab at baseline and on treatment in patients with RCC. J Immunother Cancer. 2021 Mar;9(3):e001506. doi: 10.1136/jitc-2020-001506.
Zhou Q, Qi Y, Wang Z, Zeng H, Zhang H, Liu Z, Huang Q, Xiong Y, Wang J, Chang Y, Bai Q, Xia Y, Wang Y, Liu L, Xu L, Dai B, Guo J, Zhu Y, Zhang W, Xu J. CCR5 blockade inflames antitumor immunity in BAP1-mutant clear cell renal cell carcinoma. J Immunother Cancer. 2020 Apr;8(1):e000228. doi: 10.1136/jitc-2019-000228.
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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2011-005379-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-009
Identifier Type: -
Identifier Source: org_study_id