Combination Study of Urelumab and Rituximab in Patients With B-cell Non-Hodgkins Lymphoma
A Phase 1b, Open-label, Multicenter Study of Urelumab (BMS-663513) in Combination With Rituximab in Subjects With Relapsed/Refractory B-cell Malignancies
1 other identifier
interventional
47
1 country
15
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2013
Typical duration for phase_1
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2013
CompletedFirst Posted
Study publicly available on registry
January 25, 2013
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedMarch 31, 2017
September 1, 2016
3.4 years
January 23, 2013
March 29, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Up to 110 days after last dose of Rituximab
Secondary Outcomes (7)
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
Up to approximately 3 years
Maximum observed serum concentration (Cmax) of Urelumab and Rituximab
12 time points up to Day 60 of Follow-up
Time of maximum observed serum concentration (Tmax) of Urelumab
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
12 time points up to Day 60 of Follow-up
Trough observed serum concentration (Cmin) of Urelumab and Rituximab
12 + 9 time points up to Day 60 of Follow-up
- +2 more secondary outcomes
Study Arms (2)
Arm -1 - Urelumab + Rituximab
EXPERIMENTALUrelumab (BMS-663513) flat dose intravenous infusion on specified days Rituximab intravenous flat dose infusion on specified days
Arm 1 - Urelumab + Rituximab
EXPERIMENTALUrelumab (BMS-663513) flat dose intravenous infusion on specified days Rituximab intravenous flat dose infusion on specified days
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of relapsed/refractory B-cell Malignancies (B-Non-Hodgkins Lymphoma (NHL)) per International Workshop Group (IWG)
- Progressed or refractory to at least 1 prior line of standard therapy
- Subjects in Expansion cohorts are restricted to relapsed/refractory diffuse large B-cell lymphoma (DLBCL) or Follicular Lymphoma (FL) subjects who are either relapsed or refractory to prior rituximab or ritxumab-containing chemotherapy regimens
- Follicular Lymphoma (FL) must have at least 1 lesion that can be biopsied at screening and on treatment
- Eastern Cooperative Oncology Group (ECOG) of 0 to 1
You may not qualify if:
- Active or progressing brain metastases
- Other concomitant malignancies (with some exceptions per protocol)
- Active or history of autoimmune disease
- Positive test for human immunodeficiency virus (HIV) 1\&2 or known Acquired immune deficiency syndrome (AIDS)
- History of any hepatitis (A, B or C)
- History of grade 3-4 drug-related hepatitis
- Known current drug or alcohol abuse
- Active tuberculosis (TB)
- Prior therapy with any antibody/drug that targets the T cell coregulatory proteins, including but not limited to, anti-CD137, Anti Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA4) or Anti-Glucocorticoid-induced tumor necrosis factor receptor (anti-GITR). However, Anti-Programmed Death-1 (anti-PD-1), Anti-Programmed Death-Ligand1 (anti-PD-L1) are permissible as prior therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Ucla Department Of Medicine
Los Angeles, California, 90095, United States
Stanford University Medical Center
Stanford, California, 94305, United States
University Of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140, United States
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, 52242, United States
Dana Faber Cancer Institute
Boston, Massachusetts, 02215, United States
University Of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
John Theurer Cancer Center
Hackensack, New Jersey, 07601, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 11065, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Providence Cancer Center Oncology And Hematology Care- Eastside
Portland, Oregon, 97213, United States
Hospital Of The University Of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
The University Of Texas Md Anderson Cancer Center
Houston, Texas, 77030, United States
University Of Virginia School Of Medicine
Charlottesville, Virginia, 22908, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2013
First Posted
January 25, 2013
Study Start
March 1, 2013
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
March 31, 2017
Record last verified: 2016-09