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Cancer - Solid Tumors and B-Cell Non-Hodgkin's LymphomaPhase 1NCT01471210

Safety, Tolerability, Pharmacokinetics, and Immunoregulatory Study of Urelumab (BMS-663513) in Subjects With Advanced and/or Metastatic Solid Tumors and Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma

A Phase 1 study testing Urelumab (BMS-663513) in people with Cancer - Solid Tumors and B-Cell Non-Hodgkin's Lymphoma, run by Bristol-Myers Squibb at 24 sites in 4 countries.

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 assess the safety, tolerability, pharmacokinetics and immunoregulatory activity of urelumab (BMS-663513) in cancer subjects with advanced and/or metastatic tumors and relapsed/refractory B-Cell Non-Hodgkin's Lymphoma Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Urelumab (BMS-663513)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
24 sitesin 4 countries
Study dates
Feb 2012to Apr 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

  • Signed Written Informed Consent
  • The signed informed consent form
  • Target Population
  • Subjects with advanced and/or metastatic solid tumors or B-NHL who are either refractory to or have relapsed from standard therapies, or for whom a standard therapy does not exist with measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
  • Life expectancy of 12 weeks or greater
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
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  • Adequate organ and marrow function
  • For certain subjects, willing and able to provide pre- and post-treatment fresh tumor biopsies
  • Age and Reproductive Status
  • Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy throughout the study and for at least 4 weeks prior to initiation of dosing, and for at least 60 days after the last dose of investigational product in such a manner that the risk of pregnancy is minimized
  • WOCBP must have a negative serum or urine pregnancy test [minimum sensitivity 25 UI/L or equivalent units of human chorionic gonadotrophin (HCG)] within 24 hours prior to the start of investigational product
  • Women must not be breastfeeding

Who cannot join

  • Target Disease Exceptions
  • Subjects with known or suspected brain metastasis unless previously treated and without evidence of progression
  • Subjects with a history of prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured
  • Subjects with hepatocellular carcinoma
  • Medical History and Concurrent Diseases
  • Any active autoimmune disease or documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, except for subjects with vitiligo, psoriasis inactive within past 2 years, resolved childhood asthma/atopy, or thyroid disease controlled by replacement therapy without the need for immunosuppression
Show all 32Show fewer
  • Known or suspected human immunodeficiency virus (HIV) or hepatitis A(acute), B or C infection
  • History of any hepatitis (e.g., alcohol or non-alcohol steatohepatitis (NASH), drug-related, auto-immune)
  • Evidence of active infection, requiring parenteral anti-bacterial, anti-viral or anti-fungal therapy < 7 days prior to administration of study medication
  • History of clinically significant cardiac disease, including but not limited to a history (personal or family) of congenital long QT syndrome
  • Grade > 1 QTc prolongation at baseline (> 450 msec by Bazett formula) confirmed by a repeat electrocardiogram (ECG)
  • History of myocardial infarction or uncontrolled angina within 12 months prior to administration of study drug
  • Physical and Laboratory Test Findings
  • WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 12 weeks after the last dose of investigational product
  • Women who are pregnant or breastfeeding
  • Women with a positive pregnancy test on enrollment or prior to investigational product administration
  • Sexually active fertile men not using effective birth control if their partners are WOCBP
  • Positive blood screen for hepatitis A IgM, hepatitis C antibody, hepatitis B surface antigen, or HIV-1, -2 antibody
  • Allergies and Adverse Drug Reaction
  • History of allergy to Urelumab (BMS-663513) or related compounds
  • History of significant drug allergy (such as anaphylaxis or hepatotoxicity) to a prior biologic therapy
  • Prohibited Treatments and/or Therapies
  • The systemic use of the following therapies are prohibited within 28 days of first dose of study medication, or longer where indicated:
  • Use of anti-cancer treatment (including investigational drugs) within 28 days
  • Immunosuppressive medications or immunosuppressive doses of systemic corticosteroids
  • Surgery (except minor surgeries,e.g., biopsies) or radiotherapy
  • Any non-oncology live viral vaccine therapies used for the prevention of infectious diseases.
  • Prior treatment with anti-programmed death 1 (anti-PD-1)/Programmed cell death 1 ligand 1 (PD-L1) or anti-CD137
  • Any subject with the following reported drug-related adverse events on anti- Cytotoxic T-Lymphocyte Antigen 4 (anti-CTLA4) will not be permitted on study: hepatic, diarrhea/colitis or endocrine adverse events (AE)s Grade ≥ 2, any other non-laboratory immune-related AE ≥ Grade 3. Subjects must have minimum 9 week washout period between the last dose of anti-CTLA4 and the first dose Urelumab (BMS-663513)
  • Prior organ allograft or allogeneic bone marrow transplantation
  • Other Exclusion Criteria
  • Prisoners or subjects who are involuntarily incarcerated

Trial locations and contacts

24 sites in 4 countries.

24 sites in 4 countries

United States12 sites

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • University Of Virginia Health System

    Charlottesville, Virginia, 22908

  • University Of Chicago

    Chicago, Illinois, 60637

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • John Theurer Cancer Center

    Hackensack, New Jersey, 07601

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202

  • Division Of Hematology & Oncology Ctr. For Health Sciences

    Los Angeles, California, 90095

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Hospital Of The University Of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Providence Portland Med Ctr

    Portland, Oregon, 97213

  • Stanford University Medical Center

    Stanford, California, 94305

Other trials in United States

France8 sites

  • Local Institution

    Créteil, 94010

  • Local Institution

    Lille, 59037

  • Local Institution

    Paris, 75475

  • Local Institution

    Pessac, 33604

  • Local Institution

    Pierre-Bénite, 69495

  • Local Institution

    Rennes, 35033

  • Local Institution

    Rouen, F-76038

  • Local Institution

    Villejuif, 94805

Other trials in France

Spain3 sites

  • Hospital Universitari Vall D'Hebron

    Barcelona, 08035

  • Fundacion Jimenez Diaz

    Madrid, 28040

  • Local Institution

    Pamplona, 31192

Other trials in Spain

Germany1 site

  • Local Institution

    Essen, 45147

Other trials in Germany

About this study

Official title: A Phase 1 Study of the Safety, Tolerability, Pharmacokinetics and Immunoregulatory Activity of Urelumab (BMS-663513) in Subjects With Advanced and/or Metastatic Solid Tumors and Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)

The purpose of the study is to assess the safety, tolerability, pharmacokinetics and immunoregulatory activity of urelumab (BMS-663513) in cancer subjects with advanced and/or metastatic tumors and relapsed/refractory B-Cell Non-Hodgkin's Lymphoma

Being tested
Urelumab (BMS-663513)
Medical subject headings
Lymphoma, B-Cell

What participants receive

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

  • Urelumab (BMS-663513)Drug

Study groups in NCT01471210
Study groupRoleWhat they receive
Part 1 : Urelumab (BMS-663513) Dose escalationExperimentalUrelumab (BMS-663513) solution administered intravenously on specified days
Receives: Drug: Urelumab (BMS-663513)
Part 2 : Urelumab (BMS-663513) Cohort ExpansionExperimentalUrelumab (BMS-663513) solution administered intravenously on specified days
Receives: Drug: Urelumab (BMS-663513)
Part 3:Urelumab (BMS-663513) Tumor-specific Cohort ExpansionsExperimentalEnrollment of subjects of three specific tumor types [(colorectal cancer (CRC), head and neck squamous cell carcinoma (SCCHN), and B-Cell non-Hodgkin's lymphoma (B-NHL)] who will be treated at the Maximum Tolerated Dose (MTD) (or highest dose tested)
Receives: Drug: Urelumab (BMS-663513)
Part 4:Urelumab (BMS-663513) Cohort Expansion in B-NHLExperimentalArm A and Arm B: Urelumab (BMS-663513) liquid administered intravenously on specified days exploring q3w and q6w dosing regimen
Receives: Drug: Urelumab (BMS-663513)

What is being measured

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

  1. Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, physical examinations, and clinical laboratory tests

    The incidence of adverse events will be tabulated and reviewed for potential significance and clinical Importance.

    Measured: Every 3 weeks from Baseline (Day 1) for up to 2 years

  2. Dose-limiting toxicity and maximum tolerated dose of Urelumab (BMS-663513) as determined by the incidence of dose-limiting toxicities

    Measured: Every 3 weeks from Baseline (Day 1) for up to 9 weeks of therapy

Secondary outcomes (9)

  1. Maximum observed serum concentrations (Cmax) of Urelumab (BMS-663513)

    Measured: Cycle 1 Day 1

  2. Minimum observed serum concentrations (Cmin) of Urelumab (BMS-663513)

    Measured: Cycle 2 Day 1, Cycle 3 Day 1, every 12 weeks thereafter up to 2 years

  3. Time of maximum observed serum concentration (Tmax) of Urelumab (BMS-663513)

    Measured: Cycle 1 Day 1

  4. Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] of Urelumab (BMS-663513)

    Measured: Cycle 1 Day 1 - Day 4, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 8, Cycle 3 Day 1 and every 12 weeks thereafter up to 2 years

  5. Plasma half-life (T-HALF) of Urelumab (BMS-663513)

    Measured: Cycle 1 Day 1 - Day 4, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 8, Cycle 3 Day 1 and every 12 weeks thereafter up to 2 years

  6. Total body clearance (CLT) of Urelumab (BMS-663513)

    Measured: Cycle 1 Day 1 - Day 4, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 8, Cycle 3 Day 1 and every 12 weeks thereafter up to 2 years

  7. Volume of distribution at steady-state (Vss) of Urelumab (BMS-663513)

    Measured: Cycle 1 Day 1 - Day 4, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 8, Cycle 3 Day 1 and every 12 weeks thereafter up to 2 years

  8. Human Anti-human Antibodies

    Immunogenicity of Urelumab (BMS-663513), as determined by blood sample measurements of human antihuman antibodies (HAHA)

    Measured: Cycle 1 Day 1 - Day 4, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 8, Cycle 3 Day 1 and every 12 weeks thereafter up to 2 years

  9. Tumor response and progression as determined by proportion of patients with best overall response (BOR), progression-free survival (PFS), objective response rate (ORR), time to response, and duration of response

    Measured: 9 weeks from Baseline (Day 1) and every 9 weeks until disease progression, death or last tumor assessment (Approximately up to 2 years)

Timeline

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

  1. First posted15 Nov 2011 (estimated)
  2. Study startFeb 2012
  3. Primary completionApr 2016
  4. Study completionApr 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
Single group
Masking
None (open label)
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01471210
Sponsor's protocol ID
CA186-011
Other IDs
2012-000170-28
Status last verified
Aug 2016
First submitted
10 Nov 2011
Last updated
19 Apr 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Urelumab (BMS-663513) in people with Cancer - Solid Tumors and B-Cell Non-Hodgkin's Lymphoma, run by Bristol-Myers Squibb at 24 sites in 4 countries.

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 12 inclusion and 32 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 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, France, Spain, Germany. 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 assessments will be based on medical review of adverse event reports and the results of vital sign measurements, physical examinations, and clinical laboratory tests (time frame: Every 3 weeks from Baseline (Day 1) for up to 2 years). 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 NCT01471210.

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 19 Apr 2017.

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