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OpenTrials
Completed

NCT Number: NCT01775631

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

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

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Key information

Conditions

B-cell Malignancies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ucla Department Of Medicine, Los Angeles, California, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Urelumab

Biological

Other names: BMS-663513

Rituximab

Biological

Primary outcomes

  1. 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

  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

    Time frame: Up to 110 days after last dose of Rituximab

Secondary outcomes

  1. 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

  2. Maximum observed serum concentration (Cmax) of Urelumab and Rituximab

    Time frame: 12 time points up to Day 60 of Follow-up

  3. Time of maximum observed serum concentration (Tmax) of Urelumab

    Time frame: 12 time points up to Day 60 of Follow-up

  4. 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

  5. Trough observed serum concentration (Cmin) of Urelumab and Rituximab

    Time frame: 12 + 9 time points up to Day 60 of Follow-up

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 25, 2013
Registry last updated
Mar 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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