Advanced Solid TumorsPhase 1/2NCT02253992
An Investigational Immuno-therapy Study to Determine the Safety of Urelumab Given in Combination With Nivolumab in Solid Tumors and B-cell Non-Hodgkin's Lymphoma
A Phase 1/2 study testing Urelumab and Nivolumab in people with Advanced Solid Tumors and Advanced B-cell NHL, run by Bristol-Myers Squibb at 17 sites in 4 countries.
Trial summary
The purpose of this study is to determine which doses of Urelumab and Nivolumab are safe and tolerable when they are given together. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Advanced B-cell NHL
- What is being tested?
- Urelumab and Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 17 sitesin 4 countries
- Study dates
- 29 Sep 2014to 24 May 2019
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- For Dose Escalation:
- Subjects with any previously treated advanced (metastatic or refractory) solid tumor type and B-cell non-Hodgkin lymphoma
- For Cohort Expansion:
- Subjects must have a previously treated advanced solid tumor or B cell non-Hodgkin's lymphoma to be eligible
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- For certain subjects, willing and able to provide pre-treatment and on-treatment fresh tumor biopsy
- Women of child-bearing potential and men must use an acceptable method of contraception during treatment and for 23 weeks after treatment for women and 31 weeks for men
Who cannot join
- Known 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
- Uncontrolled or significant cardiovascular disease
- History of hepatitis (B or C)
- History of active or latent tuberculosis
Trial locations and contacts
17 sites in 4 countries.
17 sites in 4 countries
United States11 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
University Of Chicago
Chicago, Illinois, 60637
Md Anderson
Houston, Texas, 77030
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Lutherville, Maryland, 21093
NYU Langone Medical Center
New York, New York, 10016
Memorial Sloan Kettering Nassau
New York, New York, 10065
Stanford University School Of Medicine
Palo Alto, California, 94304
UPMC Cancer Center
Pittsburgh, Pennsylvania, 15213
Providence Portland Medical Center
Portland, Oregon, 97213
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
France4 sites
Local Institution
Besançon, 25000
Local Institution
Marseille, 13005
Local Institution
Rennes, 35033
Local Institution
Villejuif, 94805
About this study
Official title: A Phase 1/2 Dose Escalation and Cohort Expansion Study of the Safety and Tolerability of Urelumab Administered in Combination With Nivolumab in Advanced/Metastatic Solid Tumors and B-cell Non-Hodgkins Lymphoma
The purpose of this study is to determine which doses of Urelumab and Nivolumab are safe and tolerable when they are given together.
- Conditions
- Advanced Solid Tumors, Advanced B-cell NHL
- Being tested
- Urelumab, Nivolumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UrelumabBiological
Also called BMS-663513
NivolumabBiological
Also called BMS-936558
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation and Cohort expansion: Urelumab + Nivolumab | Experimental | Nivolumab followed by Urelumab
Nivolumab every 2 weeks up to 12 cycles and Urelumab every 4 weeks up to 6 cycles Receives: Biological: Urelumab; Biological: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence of Adverse Events.
Measured: From day 1 until 100 days after participant last dose of study drug.
The Incidence of Seriuos Adverse Events.
Measured: From day 1 until 100 days after participant last dose of the study drug.
The Incidence of Death.
Measured: From day 1 until 100 days after participant last dose of study drug.
Secondary outcomes (11)
Best Overall Response (BOR)
The total number of subjects whose best overall response (BOR) is either a complete response or partial response for solid tumors and complete remission or partial remission for B-cell NHL, divided by the total number of subjects in the population of interest.
Measured: Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the total number of subjects whose BOR is either CR or PR divided by the total number of subjects in the population of interest.
Measured: Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.
Occurrence of Specific Anti-drug Antibodies (ADA) to Urelumab and Nivolumab
Measured: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Duration of Response (DOR)
DOR is defined as the number of days between the date of first response and the subsequent date of objectively documented disease progression based on the criteria (RECIST v1.1) or relapse based on IWG, or death due to any cause, if death occurred within 100 days after last dose, whichever occurs first.
Data was not collected due to discontinuation of the study/Due to study termination.
Measured: Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years
Progression-free Survival Rate (PFSR)
PFSR is defined as the probability of a subject remaining progression-free and surviving a specific length of time.
Data was not collected due to discontinuation of the study/Due to study termination.
Measured: Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.
Maximum Observed Serum Concentration (Cmax)
Data was not collected due to discontinuation of the study/Due to study termination.
Measured: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Time of Maximum Observed Serum Concentration (Tmax)
Data was not collected due to discontinuation of the study/Due to study termination.
Measured: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Area Under the Concentration-time Curve in One Dosing Interval (AUCTAU)
Data was not collected due to discontinuation of the study/Due to study termination.
Measured: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days
Trough Observed Plasma Concentration(Ctrough)
Data was not collected due to discontinuation of the study/Due to study termination.
Measured: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
End of Infusion Concentration (Ceoinf)
Data was not collected due to discontinuation of the study/Due to study termination.
Measured: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Area Under the Plasma Concentration-time Curve, 0 to Time of Last Quantifiable Concentration (AUC(0-T)
Data was not collected due to discontinuation of the study/Due to study termination.
Measured: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study start29 Sep 2014
- Primary completion24 May 2019
- Study completion24 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 232 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
- NCT02253992
- Sponsor's protocol ID
- CA186-107
- Other IDs
- 2014-002241-22, 2014
- Status last verified
- Sep 2020
- First submitted
- 29 Sep 2014
- Last updated
- 5 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- 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 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Dose Escalation and Cohort Expansion Study of the Safety and Tolerability of Urelumab Administered in Combination With Nivolumab in Advanced/Metastatic Solid Tumors and B-cell Non-Hodgkins Lymphoma
- ClinicalTrials.gov ID
- NCT02253992
- Acronym / sponsor ID
- CA186-107
- Conditions
- Advanced Solid Tumors, Advanced B-cell NHL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2014 (actual)
- Primary completion
- 24 May 2019 (actual)
- Study completion
- 24 May 2019 (actual)
- First posted
- 1 Oct 2014 (estimated)
- Results
- Posted 5 Oct 2020
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 determine which doses of Urelumab and Nivolumab are safe and tolerable when they are given together.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation and Cohort expansion: Urelumab + Nivolumab | Experimental | Biological: Urelumab, Biological: NivolumabNivolumab followed by Urelumab Nivolumab every 2 weeks up to 12 cycles and Urelumab every 4 weeks up to 6 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- For Dose Escalation:
- For Cohort Expansion:
Key exclusion criteria (6 listed)
- Known 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
- Uncontrolled or significant cardiovascular disease
- History of hepatitis (B or C)
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 | Dose Escalation and Cohort expansion: Urelumab + Nivolumab |
| NivolumabAlso: BMS-936558 | Biological | Dose Escalation and Cohort expansion: Urelumab + Nivolumab |
Primary outcome
The Incidence of Adverse Events.
Time frame: From day 1 until 100 days after participant last dose of study drug.
The Incidence of Seriuos Adverse Events.
Time frame: From day 1 until 100 days after participant last dose of the study drug.
The Incidence of Death.
Time frame: From day 1 until 100 days after participant last dose of study drug.
11 secondary outcomes
Best Overall Response (BOR)
Time frame: Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.
Objective Response Rate (ORR)
Time frame: Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.
Occurrence of Specific Anti-drug Antibodies (ADA) to Urelumab and Nivolumab
Time frame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Duration of Response (DOR)
Time frame: Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years
Progression-free Survival Rate (PFSR)
Time frame: Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.
Maximum Observed Serum Concentration (Cmax)
Time frame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Time of Maximum Observed Serum Concentration (Tmax)
Time frame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Area Under the Concentration-time Curve in One Dosing Interval (AUCTAU)
Time frame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days
Trough Observed Plasma Concentration(Ctrough)
Time frame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
End of Infusion Concentration (Ceoinf)
Time frame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Area Under the Plasma Concentration-time Curve, 0 to Time of Last Quantifiable Concentration (AUC(0-T)
Time frame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
Related trials for Advanced Solid Tumors
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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Active, not recruitingPhase 2
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RecruitingPhase 1/2
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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
17 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Urelumab and Nivolumab in people with Advanced Solid Tumors and Advanced B-cell NHL, run by Bristol-Myers Squibb at 17 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 7 inclusion and 6 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: stopped early, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, France, Germany, Spain. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Incidence of Adverse Events. (time frame: From day 1 until 100 days after participant last dose of study drug.). The study lists 3 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 NCT02253992, 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 5 Oct 2020.