Clinical trial · Interventional
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
NCT01775631CI-TRIAL-00026738completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-Cell Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab | Biological | Rituximab | ALIAS |
| Urelumab | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm -1 - Urelumab + Rituximab
- description
- Urelumab (BMS-663513) flat dose intravenous infusion on specified days Rituximab intravenous flat dose infusion on specified days
- interventionNames
- Biological: Urelumab
- Biological: Rituximab
- type
- EXPERIMENTAL
- label
- Arm 1 - Urelumab + Rituximab
- description
- Urelumab (BMS-663513) flat dose intravenous infusion on specified days Rituximab intravenous flat dose infusion on specified days
- interventionNames
- Biological: Urelumab
- Biological: Rituximab
Primary outcomes (2)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.