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B-Cell MalignanciesPhase 1NCT01775631

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

A Phase 1 study testing Urelumab and Rituximab in people with B-Cell Malignancies, run by Bristol-Myers Squibb at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
B-Cell Malignancies
What is being tested?
Urelumab and Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
15 sitesUnited States
Study dates
Mar 2013to Aug 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • University Of Michigan Health System

    Ann Arbor, Michigan, 48109

  • Dana Faber Cancer Institute

    Boston, Massachusetts, 02215

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • University Of Virginia School Of Medicine

    Charlottesville, Virginia, 22908

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • John Theurer Cancer Center

    Hackensack, New Jersey, 07601

  • The University Of Texas Md Anderson Cancer Center

    Houston, Texas, 77030

  • University Of Iowa Hospitals And Clinics

    Iowa City, Iowa, 52242

  • Ucla Department Of Medicine

    Los Angeles, California, 90095

  • University Of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 11065

  • Hospital Of The University Of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Providence Cancer Center Oncology And Hematology Care- Eastside

    Portland, Oregon, 97213

  • Stanford University Medical Center

    Stanford, California, 94305

Other trials in United States

About this study

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

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

Read the detailed description

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

Being tested
Urelumab, Rituximab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UrelumabBiological

    Also called BMS-663513

  • RituximabBiological

Study groups in NCT01775631
Study groupRoleWhat they receive
Arm -1 - Urelumab + RituximabExperimentalUrelumab (BMS-663513) flat dose intravenous infusion on specified days Rituximab intravenous flat dose infusion on specified days
Receives: Biological: Urelumab; Biological: Rituximab
Arm 1 - Urelumab + RituximabExperimentalUrelumab (BMS-663513) flat dose intravenous infusion on specified days Rituximab intravenous flat dose infusion on specified days
Receives: Biological: Urelumab; Biological: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: Up to 110 days after last dose of Rituximab

Secondary outcomes (7)

  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

    Measured: Up to approximately 3 years

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

    Measured: 12 time points up to Day 60 of Follow-up

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

    Measured: 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

    Measured: 12 time points up to Day 60 of Follow-up

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

    Measured: 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

    Measured: 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)

    Measured: Up to approximately 110 days post study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01775631
Sponsor's protocol ID
CA186-017
Status last verified
Sep 2016
First submitted
23 Jan 2013
Last updated
31 Mar 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Urelumab and Rituximab in people with B-Cell Malignancies, run by Bristol-Myers Squibb at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Up to 60 days after last dose of Urelumab). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01775631.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2017.

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