An Investigational Immuno-therapy Study to Determine the Safety of Urelumab Given in Combination With Nivolumab in Solid Tumors and B-cell Non-Hodgkin's Lymphoma
NCT ID: NCT02253992
Last Updated: 2020-10-05
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
232 participants
INTERVENTIONAL
2014-09-29
2019-05-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose Escalation and Cohort expansion: Urelumab + Nivolumab
Nivolumab followed by Urelumab
Nivolumab every 2 weeks up to 12 cycles and Urelumab every 4 weeks up to 6 cycles
Urelumab
Nivolumab
Interventions
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Urelumab
Nivolumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects with any previously treated advanced (metastatic or refractory) solid tumor type and B-cell non-Hodgkin lymphoma
* For Cohort Expansion:
* Subjects must have a previously treated advanced solid tumor or B cell non-Hodgkin's lymphoma to be eligible
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* For certain subjects, willing and able to provide pre-treatment and on-treatment fresh tumor biopsy
* Women of child-bearing potential and men must use an acceptable method of contraception during treatment and for 23 weeks after treatment for women and 31 weeks for men
Exclusion Criteria
* Other concomitant malignancies (with some exceptions per protocol)
* Active, known or suspected autoimmune disease
* Uncontrolled or significant cardiovascular disease
* History of hepatitis (B or C)
* History of active or latent tuberculosis
18 Years
ALL
No
Sponsors
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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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Stanford University School Of Medicine
Palo Alto, California, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
University Of Chicago
Chicago, Illinois, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Lutherville, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
NYU Langone Medical Center
New York, New York, United States
Memorial Sloan Kettering Nassau
New York, New York, United States
Providence Portland Medical Center
Portland, Oregon, United States
UPMC Cancer Center
Pittsburgh, Pennsylvania, United States
Md Anderson
Houston, Texas, United States
Local Institution
Besançon, , France
Local Institution
Marseille, , France
Local Institution
Rennes, , France
Local Institution
Villejuif, , France
Universitaetsklinikum Essen
Essen, , Germany
Clinica Universidad de Navarra
Pamplona, , Spain
Countries
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References
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Khushalani NI, Ott PA, Ferris RL, Cascone T, Schadendorf D, Le DT, Sharma MR, Barlesi F, Sharfman W, Luke JJ, Melero I, Lathers D, Neely J, Suryawanshi S, Sanyal A, Holloway JL, Suryawanshi R, Ely S, Segal NH. Final results of urelumab, an anti-CD137 agonist monoclonal antibody, in combination with cetuximab or nivolumab in patients with advanced solid tumors. J Immunother Cancer. 2024 Mar 7;12(3):e007364. doi: 10.1136/jitc-2023-007364.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
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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2014-002241-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA186-107
Identifier Type: -
Identifier Source: org_study_id
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