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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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.

Country

City, postcode or hospital

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

Other trials in United States

France4 sites

Local Institution
Besançon, 25000
Local Institution
Marseille, 13005
Local Institution
Rennes, 35033
Local Institution
Villejuif, 94805

Other trials in France

Germany1 site

Universitaetsklinikum Essen
Essen, 45147

Other trials in Germany

Spain1 site

Clinica Universidad de Navarra
Pamplona, 31008

Other trials in Spain

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 groups in NCT02253992
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.

29 Sep 201424 May 2019

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

All Advanced Solid Tumors trials

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

Results posted to the registry on 5 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TRT A	6	0
TRT B	4	0
TRT D	150	6

Primary outcome: The Incidence of Adverse Events.

Time frame: From day 1 until 100 days after participant last dose of study drug.. Number. Unit: Number of participants

Measure	TRT A n = 6	TRT B n = 4	TRT D n = 150
Value	6	4	150

Population analysed: All treated participants

Primary outcome: The Incidence of Seriuos Adverse Events.

Time frame: From day 1 until 100 days after participant last dose of the study drug.. Number. Unit: Number of participants

Measure	TRT A n = 6	TRT B n = 4	TRT D n = 150
Value	3	3	86

Population analysed: All treated participants

Primary outcome: The Incidence of Death.

Time frame: From day 1 until 100 days after participant last dose of study drug.. Number. Unit: Number of participants

Measure	TRT A n = 6	TRT B n = 4	TRT D n = 150
Value	6	2	93

Population analysed: All Treated participants

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TRT A	3 of 6 (50%)	6 of 6 (100%)	6 of 6
TRT B	3 of 4 (75%)	4 of 4 (100%)	2 of 4
TRT D	86 of 150 (57.3%)	147 of 150 (98%)	93 of 150

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

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

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.