A Phase 1 interventional study of Urelumab and Rituximab in B-Cell Malignancies, sponsored by Bristol-Myers Squibb. Completed at 15 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-31.
Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment
The purpose of the study is to determine the safety, tolerability and maximum tolerated dose of Urelumab in combination with Rituximab in patients with B-cell Non-Hodgkins Lymphoma
Intervention model: Dose Escalation (part 1) of study= Sequential Design; Dose Expansion (part 2) of study= Parallel Design
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 47 is close to the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
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Inclusion Criteria:
Exclusion Criteria:
Urelumab (BMS-663513) flat dose intravenous infusion on specified days Rituximab intravenous flat dose infusion on specified days
Biological: Urelumab · Biological: Rituximab
Urelumab (BMS-663513) flat dose intravenous infusion on specified days Rituximab intravenous flat dose infusion on specified days
Biological: Urelumab · Biological: Rituximab
Also known as: BMS-663513
Safety and tolerability of Urelumab in combination with Rituximab as measured by incidence of adverse events (AEs), serious AEs, death, vital sign changes, electrocardiograms (ECGs), physical examination results, and laboratory test abnormalities
Time frame: Up to 60 days after last dose of Urelumab
Safety and tolerability of Urelumab in combination with Rituximab as measured by incidence of adverse events (AEs), serious AEs, death, vital sign changes, electrocardiograms (ECGs), physical examination results, and laboratory test abnormalities
Time frame: Up to 110 days after last dose of Rituximab
Efficacy-Antitumor Activity of Urelumab in combination with Rituximab as measured by best overall response, progression-free survival, time to response, and duration of response
Time frame: Up to approximately 3 years
Maximum observed serum concentration (Cmax) of Urelumab and Rituximab
Time frame: 12 time points up to Day 60 of Follow-up
Time of maximum observed serum concentration (Tmax) of Urelumab
Time frame: 12 time points up to Day 60 of Follow-up
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of Urelumab
Time frame: 12 time points up to Day 60 of Follow-up
Trough observed serum concentration (Cmin) of Urelumab and Rituximab
Time frame: 12 + 9 time points up to Day 60 of Follow-up
Area under the concentration-time curve (AUC) in one dosing interval (AUC(TAU)) of Urelumab
Time frame: 12 time points up to Day 60 of Follow-up
Immunogenicity of Urelumab in combination with Rituximab as determined by blood sample measurements of anti-drug antibodies (ADA)
Time frame: Up to approximately 110 days post study drug
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Bristol-Myers Squibb