Colorectal CancerPhase 1NCT02110082
Combination Study of Urelumab and Cetuximab in Patients With Advanced/Metastatic Colorectal Cancer or Advanced/Metastatic Head and Neck Cancer
A Phase 1 study testing Urelumab and Cetuximab in people with Colorectal Cancer and Head and Neck Cancer, run by Bristol-Myers Squibb at 7 sites in United States.
Trial summary
The purpose of the study is to determine the safety, tolerability and maximum tolerated dose of Urelumab in combination with Cetuximab in patients with Advanced/Metastatic Colorectal Cancer or Advanced/Metastatic Squamous Cell Carcinoma of the Head and Neck. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Head and Neck Cancer
- What is being tested?
- Urelumab and Cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 7 sitesUnited States
- Study dates
- Apr 2014to Dec 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
- Subjects with advanced/metastatic Colorectal Cancer(CRC) who have failed or been intolerant to both irinotecan- and oxaliplatin- based regimens
- Subjects with advanced/metastatic Squamous cell carcinoma of the head and neck (SCCHN) who are without options for curative treatment
- Subjects must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
- Men and women 18 and older
- Women of childbearing potential (WOCBP) and men must use highly effective methods of contraception
- Eastern Cooperative Oncology Group (ECOG) of 0 or 1
- Subjects must have a life expectancy of at least 3 months
Who cannot join
- Active or progressing brain metastases
- Other concomitant malignancies (with some exceptions per protocol)
- Nasopharyngeal carcinoma
- Active or history of autoimmune disease
- Positive test for Human Immunodeficiency Virus (HIV) 1\&2 or known AIDS
- History of any hepatitis (A,B or C)
Show all 11Show fewer
- Known current drug or alcohol abuse
- Active Tuberculosis (TB)
- Use of anti-cancer treatments within 28 days
- Prior therapy with anti-CD137 antibody
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
University Of Chicago
Chicago, Illinois, 60637
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Upmc Cancer Center
Pittsburgh, Pennsylvania, 15213
Providence Oncology & Hematology Care Eastside
Portland, Oregon, 97213
Stanford University
Stanford, California, 94305
About this study
Official title: A Phase 1b, Open-label, Multicenter Study of Urelumab (BMS-663513) in Combination With Cetuximab in Subjects With Advanced/Metastatic Colorectal Cancer or Advanced/Metastatic Squamous Cell Carcinoma of the Head and Neck
The purpose of the study is to determine the safety, tolerability and maximum tolerated dose of Urelumab in combination with Cetuximab in patients with Advanced/Metastatic Colorectal Cancer or Advanced/Metastatic Squamous Cell Carcinoma of the Head and Neck.
- Conditions
- Colorectal Cancer, Head and Neck Cancer
- Being tested
- Urelumab, Cetuximab
- Medical subject headings
- Colorectal Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UrelumabBiological
Also called BMS-663513
CetuximabBiological
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Urelumab + Cetuximab | Experimental | Urelumab every 3 weeks with Cetuximab weekly through Intravenous infusion Receives: Biological: Urelumab; Biological: Cetuximab |
| Cohort 2: Urelumab + Cetuximab | Experimental | Urelumab every 3 weeks with Cetuximab weekly through Intravenous infusion Receives: Biological: Urelumab; Biological: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary safety endpoint is the incidence, potential significance, and clinical importance of adverse events
As determined by medical review of adverse event reports, vital sign measurements, electrocardiograms (ECGs), and results of physical examination and laboratory tests During a 3 week cycle, safety labs are done on Days 1, 2, 3, 5, 8, and 15. Starting on Cycle 3, Day 1, Chemistry (excluding Liver function test (LFTs)) are to be performed on Day 1 and Day 15 of each cycle thereafter. Physical exams are done on Day 1 of each cycle. Vital signs are done on Days 1, 2, 8, and 15 at Cycle 1 and then on Days 1 and 2 of each cycle thereafter. Adverse events are collected from screening to 60 days after last dose of Urelumab
Measured: Approximately 2 years
Secondary outcomes (12)
Objective response rate (ORR)
Measured: Up to 2 years
Duration of Objective Response (DOR)
Measured: Up to 2 years
Progression Free Survival (PFS)
Measured: Up to 2 years
Immunogenicity measured by the occurrence of anti-drug antibody after the administration of BMS-663513
Measured: Up to 2 years
Maximum observed serum concentration (Cmax) of BMS-663513 in combination with Cetuximab
Measured: Up to 2 years
Time of maximum observed serum concentration (Tmax) of BMS-663513 in combination with Cetuximab
Measured: Up to 2 years
Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-663513 in combination with Cetuximab
Measured: Up to 2 years
Area under the serum concentration-time curve from time zero to the time of last quantifiable serum concentration (AUC(0-T)) of BMS-663513 in combination with Cetuximab
Measured: Up to 2 years
Elimination half-life (T-HALF) of BMS-663513 in combination with Cetuximab
Measured: Up to 2 years
Total body clearance (CLT) of BMS-663513 in combination with Cetuximab
Measured: Up to 2 years
Volume of distribution at steady-state (Vss) of BMS-663513 in combination with Cetuximab
Measured: Up to 2 years
Trough observed concentration (Cmin) of BMS-663513 in combination with Cetuximab
Measured: 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.
- First posted10 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110082
- Sponsor's protocol ID
- CA186-018
- Status last verified
- Apr 2017
- First submitted
- 8 Apr 2014
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Khushalani NI, Ott PA, Ferris RL, Cascone T, Schadendorf D, Le DT, Sharma MR, Barlesi F, Sharfman W, Luke JJ, Melero I, Lathers D, Neely J, Suryawanshi S, Sanyal A, Holloway JL, Suryawanshi R, Ely S, Segal NH. Final results of urelumab, an anti-CD137 agonist monoclonal antibody, in combination with cetuximab or nivolumab in patients with advanced solid tumors. J Immunother Cancer. 2024 Mar 7;12(3):e007364. doi: 10.1136/jitc-2023-007364.
PubMed 38458639
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Open-label, Multicenter Study of Urelumab (BMS-663513) in Combination With Cetuximab in Subjects With Advanced/Metastatic Colorectal Cancer or Advanced/Metastatic Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT02110082
- Acronym / sponsor ID
- CA186-018
- Conditions
- Colorectal Cancer, Head and Neck Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 Apr 2014 (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 the study is to determine the safety, tolerability and maximum tolerated dose of Urelumab in combination with Cetuximab in patients with Advanced/Metastatic Colorectal Cancer or Advanced/Metastatic Squamous Cell Carcinoma of the Head and Neck.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Urelumab + Cetuximab | Experimental | Biological: Urelumab, Biological: CetuximabUrelumab every 3 weeks with Cetuximab weekly through Intravenous infusion |
| Cohort 2: Urelumab + Cetuximab | Experimental | Biological: Urelumab, Biological: CetuximabUrelumab every 3 weeks with Cetuximab weekly through Intravenous infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects with advanced/metastatic Colorectal Cancer(CRC) who have failed or been intolerant to both irinotecan- and oxaliplatin- based regimens
- Subjects with advanced/metastatic Squamous cell carcinoma of the head and neck (SCCHN) who are without options for curative treatment
- Subjects must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
- Men and women 18 and older
- Women of childbearing potential (WOCBP) and men must use highly effective methods of contraception
Key exclusion criteria (11 listed)
- Active or progressing brain metastases
- Other concomitant malignancies (with some exceptions per protocol)
- Nasopharyngeal carcinoma
- Active or history of autoimmune disease
- Positive test for Human Immunodeficiency Virus (HIV) 1\&2 or known AIDS
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 |
|---|---|---|
| UrelumabAlso: BMS-663513 | Biological | Cohort 1: Urelumab + Cetuximab, Cohort 2: Urelumab + Cetuximab |
| Cetuximab | Biological | Cohort 1: Urelumab + Cetuximab, Cohort 2: Urelumab + Cetuximab |
Primary outcome
The primary safety endpoint is the incidence, potential significance, and clinical importance of adverse events
Time frame: Approximately 2 years
As determined by medical review of adverse event reports, vital sign measurements, electrocardiograms (ECGs), and results of physical examination and laboratory tests During a 3 week cycle, safety labs are done on Days 1, 2, 3, 5, 8, and 15. Starting on Cycle 3, Day 1, Chemistry (excluding Liver function test (LFTs)) are to be performed on Day 1 and Day 15 of each cycle thereafter. Physical exams are done on Day 1 of each cycle. Vital signs are done on Days 1, 2, 8, and 15 at Cycle 1 and then on Days 1 and 2 of each cycle thereafter. Adverse events are collected from screening to 60 days after last dose of Urelumab
12 secondary outcomes
Objective response rate (ORR)
Time frame: Up to 2 years
Duration of Objective Response (DOR)
Time frame: Up to 2 years
Progression Free Survival (PFS)
Time frame: Up to 2 years
Immunogenicity measured by the occurrence of anti-drug antibody after the administration of BMS-663513
Time frame: Up to 2 years
Maximum observed serum concentration (Cmax) of BMS-663513 in combination with Cetuximab
Time frame: Up to 2 years
Time of maximum observed serum concentration (Tmax) of BMS-663513 in combination with Cetuximab
Time frame: Up to 2 years
Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-663513 in combination with Cetuximab
Time frame: Up to 2 years
Area under the serum concentration-time curve from time zero to the time of last quantifiable serum concentration (AUC(0-T)) of BMS-663513 in combination with Cetuximab
Time frame: Up to 2 years
Elimination half-life (T-HALF) of BMS-663513 in combination with Cetuximab
Time frame: Up to 2 years
Total body clearance (CLT) of BMS-663513 in combination with Cetuximab
Time frame: Up to 2 years
Volume of distribution at steady-state (Vss) of BMS-663513 in combination with Cetuximab
Time frame: Up to 2 years
Trough observed concentration (Cmin) of BMS-663513 in combination with Cetuximab
Time frame: Up to 2 years
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 19 Apr 2017.
- Derived from this study: PubMed 38458639Khushalani NI, Ott PA, Ferris RL, Cascone T, Schadendorf D, Le DT, Sharma MR, Barlesi F, Sharfman W, Luke JJ, Melero I, Lathers D, Neely J, Suryawanshi S, Sanyal A, Holloway JL, Suryawanshi R, Ely S, Segal NH. Final results of urelumab, an anti-CD137 agonist monoclonal antibody, in combination with cetuximab or nivolumab in patients with advanced solid tumors. J Immunother Cancer. 2024 Mar 7;12(3):e007364. doi: 10.1136/jitc-2023-007364.
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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
7 sites 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 Cetuximab in people with Colorectal Cancer and Head and Neck Cancer, run by Bristol-Myers Squibb at 7 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 7 inclusion and 11 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 7 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?
The primary safety endpoint is the incidence, potential significance, and clinical importance of adverse events (time frame: Approximately 2 years). 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 NCT02110082, which also lists 1 linked publication.
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.