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

B-Cell Malignancies Clinical Trial

Official title:

A Phase 1b, Open-label, Multicenter Study of Urelumab (BMS-663513) in Combination With Rituximab in Subjects With Relapsed/Refractory B-cell Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01775631
• Other study ID #: CA186-017
• Status: Completed
• Phase: Phase 1
• First received: January 23, 2013
• Last updated: March 29, 2017
• Start date: March 2013
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Intervention model: Dose Escalation (part 1) of study= Sequential Design; Dose Expansion (part 2) of study= Parallel Design

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• B-Cell Malignancies
• Neoplasms

Intervention

Biological:
• Urelumab

• Rituximab

Locations

Country	Name	City	State
United States	University Of Michigan Health System	Ann Arbor	Michigan
United States	Dana Faber Cancer Institute	Boston	Massachusetts
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	University Of Virginia School Of Medicine	Charlottesville	Virginia
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	John Theurer Cancer Center	Hackensack	New Jersey
United States	The University Of Texas Md Anderson Cancer Center	Houston	Texas
United States	University Of Iowa Hospitals And Clinics	Iowa City	Iowa
United States	Ucla Department Of Medicine	Los Angeles	California
United States	University Of Miami Sylvester Comprehensive Cancer Center	Miami	Florida
United States	Mount Sinai Comprehensive Cancer Center	Miami Beach	Florida
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Hospital Of The University Of Pennsylvania	Philadelphia	Pennsylvania
United States	Providence Cancer Center Oncology And Hematology Care- Eastside	Portland	Oregon
United States	Stanford University Medical Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Maximum observed serum concentration (Cmax) of Urelumab and Rituximab		12 time points up to Day 60 of Follow-up
Secondary	Time of maximum observed serum concentration (Tmax) of Urelumab		12 time points up to Day 60 of Follow-up
Secondary	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
Secondary	Trough observed serum concentration (Cmin) of Urelumab and Rituximab		12 + 9 time points up to Day 60 of Follow-up
Secondary	Area under the concentration-time curve (AUC) in one dosing interval (AUC(TAU)) of Urelumab		12 time points up to Day 60 of Follow-up
Secondary	Immunogenicity of Urelumab in combination with Rituximab as determined by blood sample measurements of anti-drug antibodies (ADA)		Up to approximately 110 days post study drug

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form