Study of Urelumab in Subjects With Advanced and/or Metastatic Malignant Tumors

May 14, 2020 updated by: Bristol-Myers Squibb

A Phase 1 Study of the Safety, Tolerability, Pharmacokinetics and Immunoregulatory Activity of Urelumab (BMS-663513) in Subjects With Advanced and/or Metastatic Malignant Tumors

The purpose of this study is to assess the safety and tolerability of BMS-663513 in subjects with advanced and/or metastatic malignant tumors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Hyogo
      • Kobe-shi, Hyogo, Japan, 6500017
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Subjects with previously treated advanced malignant solid tumor
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  • For certain subjects, willing and able to provide pre-treatment tumor sample

Exclusion Criteria:

  • Known or suspected central nervous system metastases or central nervous system as the only source of disease
  • Other concomitant malignancies (with some exceptions per protocol)
  • Active, known or suspected autoimmune disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Urelumab (+ Nivolumab) intravenous (IV) infusion
Drug: Nivolumab
Drug: Urelumab

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Safety of urelumab monotherapy as measured by the dose limiting toxicity (DLT) in subjects with advanced and/or metastatic malignant tumors
Time Frame: From day 1 of treatment up to 60 days of follow-up
From day 1 of treatment up to 60 days of follow-up
Safety of urelumab monotherapy as measured by adverse events (AEs) and serious adverse events (SAEs) in subjects with advanced and/or metastatic malignant tumors
Time Frame: From day 1 of treatment up to 60 days of follow-up
From day 1 of treatment up to 60 days of follow-up
Tolerability of urelumab monotherapy as measured by the DLT in subjects with advanced and/or metastatic malignant tumors
Time Frame: From day 1 of treatment up to 60 days of follow-up
From day 1 of treatment up to 60 days of follow-up
Tolerability of urelumab monotherapy as measured by AEs and SAEs in subjects with advanced and/or metastatic malignant tumors
Time Frame: From day 1 of treatment up to 60 days of follow-up
From day 1 of treatment up to 60 days of follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety of urelumab-nivolumab combination therapy as measured by AEs and SAEs in subjects with advanced and/or metastatic malignant tumors
Time Frame: From day 1 of treatment up to 100 days of follow-up
From day 1 of treatment up to 100 days of follow-up
Tolerability of urelumab-nivolumab combination therapy as measured by AEs and SAEs in subjects with advanced and/or metastatic malignant tumors
Time Frame: From day 1 of treatment up to 100 days of follow-up
From day 1 of treatment up to 100 days of follow-up
Cmax (Maximum observed serum concentration) of urelumab when administered alone
Time Frame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
21 days/cycle for Urelumab monotherapy
Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
Ctrough (Trough observed serum concentration) of urelumab when administered alone
Time Frame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
21 days/cycle for Urelumab monotherapy
Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
Tmax (Time of maximum observed serum concentration) of urelumab when administered alone
Time Frame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
21 days/cycle for Urelumab monotherapy
Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
AUC(0-T) [Area under the concentration-time curve from time zero to the last quantifiable concentration] of urelumab when administered alone
Time Frame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
21 days/cycle for Urelumab monotherapy
Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
AUC(TAU) [Area under the concentration-time curve in one dosing interval] of urelumab when administered alone
Time Frame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
21 days/cycle for Urelumab monotherapy
Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
AUC(INF) [Area under the concentration-time curve from time zero to infinity and the extrapolated area] of urelumab when administered alone
Time Frame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
21 days/cycle for Urelumab monotherapy
Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
T-HALF (Elimination half life) of urelumab when administered alone
Time Frame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
21 days/cycle for Urelumab monotherapy
Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
CLT (Total body clearance) of urelumab when administered alone
Time Frame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
21 days/cycle for Urelumab monotherapy
Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
Vss (Volume of distribution at steady state) of urelumab when administered alone
Time Frame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
21 days/cycle for Urelumab monotherapy
Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
AI (Accumulation Index: ratio of AUC(TAU) and Cmax in cycle at steady state to those after the first cycle) of urelumab when administered alone
Time Frame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
21 days/cycle for Urelumab monotherapy
Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
Cmax of urelumab when co-administered
Time Frame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
28 days/cycle for combination therapy of Urelumab and Nivolumab
Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
Coeff of urelumab when co-administered
Time Frame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
28 days/cycle for combination therapy of Urelumab and Nivolumab
Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
Ctrough of urelumab and nivolumab when co-administered
Time Frame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
28 days/cycle for combination therapy of Urelumab and Nivolumab
Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
Tmax of urelumab and nivolumab when co-administered
Time Frame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
28 days/cycle for combination therapy of Urelumab and Nivolumab
Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
AUC(0-T) of urelumab and nivolumab when co-administered
Time Frame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
28 days/cycle for combination therapy of Urelumab and Nivolumab
Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
AUC(TAU) of urelumab and nivolumab when co-administered
Time Frame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
28 days/cycle for combination therapy of Urelumab and Nivolumab
Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
AUC(INF) of urelumab and nivolumab when co-administered
Time Frame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
28 days/cycle for combination therapy of Urelumab and Nivolumab
Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
T-HALF of urelumab when co-administered
Time Frame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
28 days/cycle for combination therapy of Urelumab and Nivolumab
Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
CLT of urelumab when co-administered
Time Frame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
28 days/cycle for combination therapy of Urelumab and Nivolumab
Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
Vss of urelumab when co-administered
Time Frame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
28 days/cycle for combination therapy of Urelumab and Nivolumab
Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
Anti-drug Antibody (ADA) status of the subject in response to Urelumab when administered alone
Time Frame: Cycle 1, 2, 4, 8, 12, 16, up to 60 days of follow up
21 days/cycle for Urelumab monotherapy
Cycle 1, 2, 4, 8, 12, 16, up to 60 days of follow up
ADA status of the subject in response to Urelumab and Nivolumab when co-administered
Time Frame: Cycle 1, 2, 4, 5, 9, up to 100 days of follow up
28 days/cycle for combination therapy of Urelumab and Nivolumab
Cycle 1, 2, 4, 5, 9, up to 100 days of follow up
Best overall response (BOR) of urelumab monotherapy
Time Frame: Every 6-8 weeks during the treatment period
Every 6-8 weeks during the treatment period
BOR of urelumab and nivolumab combination therapy
Time Frame: Every 6-8 weeks during the treatment period
Every 6-8 weeks during the treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ono Pharmaceutical Co. Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 11, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 11, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA186-110

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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