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Combination Study of Urelumab and Rituximab in Patients With B-cell Non-Hodgkins Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01775631
Recruitment Status : Completed
First Posted : January 25, 2013
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE January 23, 2013
First Posted Date  ICMJE January 25, 2013
Last Update Posted Date March 31, 2017
Study Start Date  ICMJE March 2013
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2013)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2013)
  • 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 2 years ]
  • Maximum observed serum concentration (Cmax) of Urelumab and Rituximab [ Time Frame: 15 time points up to Day 60 of Follow-up ]
  • Time of maximum observed serum concentration (Tmax) of Urelumab [ Time Frame: 15 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: 15 time points up to Day 60 of Follow-up ]
  • Trough observed serum concentration (Cmin) of Urelumab and Rituximab [ Time Frame: 15 time points up to Day 60 of Follow-up ]
  • Area under the concentration-time curve in one dosing interval [AUC(TAU)] of Urelumab [ Time Frame: 15 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 2.33 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Study of Urelumab and Rituximab in Patients With B-cell Non-Hodgkins Lymphoma
Official Title  ICMJE A Phase 1b, Open-label, Multicenter Study of Urelumab (BMS-663513) in Combination With Rituximab in Subjects With Relapsed/Refractory B-cell Malignancies
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
Detailed Description Intervention model: Dose Escalation (part 1) of study= Sequential Design; Dose Expansion (part 2) of study= Parallel Design
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE B-Cell Malignancies
Intervention  ICMJE
  • Biological: Urelumab
    Other Name: BMS-663513
  • Biological: Rituximab
Study Arms  ICMJE
  • Experimental: Arm -1 - Urelumab + Rituximab

    Urelumab (BMS-663513) flat dose intravenous infusion on specified days

    Rituximab intravenous flat dose infusion on specified days

    Interventions:
    • Biological: Urelumab
    • Biological: Rituximab
  • Experimental: Arm 1 - Urelumab + Rituximab

    Urelumab (BMS-663513) flat dose intravenous infusion on specified days

    Rituximab intravenous flat dose infusion on specified days

    Interventions:
    • Biological: Urelumab
    • Biological: Rituximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 20, 2016)
47
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2013)
104
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01775631
Other Study ID Numbers  ICMJE CA186-017
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP