Malignant TumorsPhase 1NCT02534506
Study of Urelumab in Subjects With Advanced and/or Metastatic Malignant Tumors
A Phase 1 study testing Urelumab and Nivolumab in people with Malignant Tumors, run by Bristol-Myers Squibb at 1 site in Japan.
Trial summary
The purpose of this study is to assess the safety and tolerability of BMS-663513 in subjects with advanced and/or metastatic malignant tumors. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Malignant Tumors
- What is being tested?
- Urelumab and Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteJapan
- Study dates
- 6 Nov 2015to 11 Nov 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
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 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.
- Conditions
- Malignant Tumors
- Being tested
- Urelumab, Nivolumab
- Keywords
- Advanced malignant tumors, Metastatic malignant tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UrelumabDrug
NivolumabDrug
| Study group | Role | What they receive |
|---|---|---|
| Urelumab (+ Nivolumab) intravenous (IV) infusion | Experimental | Not described Receives: Drug: Urelumab; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of urelumab monotherapy as measured by the dose limiting toxicity (DLT) in subjects with advanced and/or metastatic malignant tumors
Measured: 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
Measured: 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
Measured: 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
Measured: From day 1 of treatment up to 60 days of follow-up
Secondary outcomes (26)
Safety of urelumab-nivolumab combination therapy as measured by AEs and SAEs in subjects with advanced and/or metastatic malignant tumors
Measured: 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
Measured: From day 1 of treatment up to 100 days of follow-up
Cmax (Maximum observed serum concentration) of urelumab when administered alone
21 days/cycle for Urelumab monotherapy
Measured: 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
21 days/cycle for Urelumab monotherapy
Measured: 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
21 days/cycle for Urelumab monotherapy
Measured: 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
21 days/cycle for Urelumab monotherapy
Measured: 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
21 days/cycle for Urelumab monotherapy
Measured: 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
21 days/cycle for Urelumab monotherapy
Measured: 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
21 days/cycle for Urelumab monotherapy
Measured: 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
21 days/cycle for Urelumab monotherapy
Measured: 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
21 days/cycle for Urelumab monotherapy
Measured: 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
21 days/cycle for Urelumab monotherapy
Measured: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
Cmax of urelumab when co-administered
28 days/cycle for combination therapy of Urelumab and Nivolumab
Measured: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
Coeff of urelumab when co-administered
28 days/cycle for combination therapy of Urelumab and Nivolumab
Measured: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
Ctrough of urelumab and nivolumab when co-administered
28 days/cycle for combination therapy of Urelumab and Nivolumab
Measured: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
Tmax of urelumab and nivolumab when co-administered
28 days/cycle for combination therapy of Urelumab and Nivolumab
Measured: 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
28 days/cycle for combination therapy of Urelumab and Nivolumab
Measured: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
AUC(TAU) of urelumab and nivolumab when co-administered
28 days/cycle for combination therapy of Urelumab and Nivolumab
Measured: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
AUC(INF) of urelumab and nivolumab when co-administered
28 days/cycle for combination therapy of Urelumab and Nivolumab
Measured: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
T-HALF of urelumab when co-administered
28 days/cycle for combination therapy of Urelumab and Nivolumab
Measured: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
CLT of urelumab when co-administered
28 days/cycle for combination therapy of Urelumab and Nivolumab
Measured: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
Vss of urelumab when co-administered
28 days/cycle for combination therapy of Urelumab and Nivolumab
Measured: 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
21 days/cycle for Urelumab monotherapy
Measured: 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
28 days/cycle for combination therapy of Urelumab and Nivolumab
Measured: Cycle 1, 2, 4, 5, 9, up to 100 days of follow up
Best overall response (BOR) of urelumab monotherapy
Measured: Every 6-8 weeks during the treatment period
BOR of urelumab and nivolumab combination therapy
Measured: Every 6-8 weeks during the treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study start6 Nov 2015
- Primary completion11 Nov 2016
- Study completion11 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant TumorsStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534506
- Sponsor's protocol ID
- CA186-110
- Status last verified
- May 2020
- First submitted
- 5 Aug 2015
- Last updated
- 18 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Malignant Tumors
- ClinicalTrials.gov ID
- NCT02534506
- Acronym / sponsor ID
- CA186-110
- Conditions
- Malignant Tumors
- Keywords
- Advanced malignant tumors, Metastatic malignant tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Study start
- 6 Nov 2015 (actual)
- Primary completion
- 11 Nov 2016 (actual)
- Study completion
- 11 Nov 2016 (actual)
- First posted
- 27 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Urelumab (+ Nivolumab) intravenous (IV) infusion | Experimental | Drug: Urelumab, Drug: Nivolumab |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urelumab | Drug | Urelumab (+ Nivolumab) intravenous (IV) infusion |
| Nivolumab | Drug | Urelumab (+ Nivolumab) intravenous (IV) infusion |
Primary outcome
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
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
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
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
26 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
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
Cmax of urelumab when co-administered
Time frame: 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
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
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
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
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
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
T-HALF of urelumab when co-administered
Time frame: 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
Vss of urelumab when co-administered
Time frame: 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
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
Best overall response (BOR) of urelumab monotherapy
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Urelumab and Nivolumab in people with Malignant Tumors, run by Bristol-Myers Squibb at 1 site in Japan.
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 3 inclusion and 3 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 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2020.