Solid TumorPhase 1/2CXCessoR4NCT02472977
Safety and Efficacy Study of Ulocuplumab and Nivolumab in Subjects With Solid Tumors
A Phase 1/2 study testing Ulocuplumab and Nivolumab in people with Solid Tumor, run by Bristol-Myers Squibb at 7 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether the combination of Ulocuplumab and Nivolumab is safe and effective in the treatment of pancreatic cancer and small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Ulocuplumab and Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 13 Jul 2015to 27 Jan 2017
- 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
- SCLC or PAC that is advanced or has spread to other parts of the body
- Treated with at least one other chemotherapy that did not work or where cancer relapsed
- Minimal limitations on activities of daily living as measured by Eastern Cooperative Oncology Group (ECOG) score of 0-1
Who cannot join
- Patients with cancer that spread to the brain
- Active, known or suspected autoimmune disease
- Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
University Of Colorado Hosp
Aurora, Colorado, 80045
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, 21287
Indiana University Health
Indianapolis, Indiana, 46202
Columbia University Medical Center (Cumc)
New York, New York, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
Official title: A Phase 1/2 Study of the Safety and Efficacy of Ulocuplumab Combined With Nivolumab in Subjects With Advanced or Metastatic Solid Tumors
The purpose of this study is to determine whether the combination of Ulocuplumab and Nivolumab is safe and effective in the treatment of pancreatic cancer and small cell lung cancer.
Read the detailed description
- Intervention model: Single group for Stage 1 DLT, then Parallel
- Data Monitoring Committee: No (Stage 1) Yes (Stage 2 Randomized Ph2)
- Conditions
- Solid Tumor
- Being tested
- Ulocuplumab, Nivolumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UlocuplumabDrug
Also called BMS-936564
NivolumabDrug
| Study group | Role | What they receive |
|---|---|---|
| BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (SCLC) | Active comparator | Small cell lung cancer (SCLC) Receives: Drug: Ulocuplumab; Drug: Nivolumab |
| BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (PAC) | Active comparator | Pancreatic cancer (PAC) Receives: Drug: Ulocuplumab; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Immune-mediated AEs
The number participants who experienced on-study AEs, SAEs, and AEs requiring immune modulating medication is reported.
Measured: From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months)
Objective Response Rate (ORR) Per RECIST 1.1 Criteria
ORR is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants. BOR is defined as the best response designation recorded between the first dose date and the date of progression per RECIST 1.1, or the date of subsequent anti-cancer therapy, whichever occurs first. CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD)=At least a 20% increase in the sum of diameters of target lesions, referencing the smallest sum on study, and an absolute increase of at least 5 mm, or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referencing the smallest sum diameters while on study.
Measured: From first dose until disease progression or treatment discontinuation (assessed up to January 2017, approximately 18 months)
Overall Survival (OS)
If a Phase 2 comparative study is initiated and, for PAC only: Overall Survival is defined as the time from randomization to date of death due to any cause.
Measured: From date of randomization to date of death (assessed up to study completion, approximately 18 months)
Number of Participants With Laboratory Abnormalities
The number of participants who experienced on-study Grade 3 or 4 laboratory abnormalities (without Grade 3 or 4 abnormality at baseline) was reported for each arm.
Measured: From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months)
Number of Participants With Electrocardiogram Abnormalities
The number of participants experiencing electrocardiogram abnormalities was reported for each arm
Measured: From first dose to date of last dose plus 30 days
Secondary outcomes (1)
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from first dosing date to the date of the first documented tumor progression, as determined by the investigator according to RECIST 1.1 criteria, or death due to any cause, whichever occurs first. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. PFS was not assessed for this study due to the small number of participants.
Measured: From first dose to date of progression (assessed up to January 2017, approximately 18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2015 (estimated)
- Study start13 Jul 2015
- Primary completion27 Jan 2017
- Study completion27 Jan 2017
Why it stopped: Trial terminated because of lack of efficacy in the short term acute phase
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.
- Other trials for Solid TumorStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 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
- NCT02472977
- Sponsor's protocol ID
- CA212-115
- Other IDs
- 2015-000136-15, 2015
- Acronym
- CXCessoR4
- Status last verified
- Oct 2018
- First submitted
- 12 Jun 2015
- Last updated
- 1 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of the Safety and Efficacy of Ulocuplumab Combined With Nivolumab in Subjects With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT02472977
- Acronym / sponsor ID
- CXCessoR4 / CA212-115
- Conditions
- Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial terminated because of lack of efficacy in the short term acute phase
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2015 (actual)
- Primary completion
- 27 Jan 2017 (actual)
- Study completion
- 27 Jan 2017 (actual)
- First posted
- 16 Jun 2015 (estimated)
- Results
- Posted 29 Mar 2018
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 whether the combination of Ulocuplumab and Nivolumab is safe and effective in the treatment of pancreatic cancer and small cell lung cancer.
Detailed description
- Intervention model: Single group for Stage 1 DLT, then Parallel
- Data Monitoring Committee: No (Stage 1) Yes (Stage 2 Randomized Ph2)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (SCLC) | Active comparator | Drug: Ulocuplumab, Drug: NivolumabSmall cell lung cancer (SCLC) |
| BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (PAC) | Active comparator | Drug: Ulocuplumab, Drug: NivolumabPancreatic cancer (PAC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- SCLC or PAC that is advanced or has spread to other parts of the body
- Treated with at least one other chemotherapy that did not work or where cancer relapsed
- Minimal limitations on activities of daily living as measured by Eastern Cooperative Oncology Group (ECOG) score of 0-1
Key exclusion criteria (3 listed)
- Patients with cancer that spread to the brain
- Active, known or suspected autoimmune disease
- Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)
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 |
|---|---|---|
| UlocuplumabAlso: BMS-936564 | Drug | BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (PAC), BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (SCLC) |
| Nivolumab | Drug | BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (PAC), BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (SCLC) |
Primary outcome
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Immune-mediated AEs
Time frame: From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months)
The number participants who experienced on-study AEs, SAEs, and AEs requiring immune modulating medication is reported.
Objective Response Rate (ORR) Per RECIST 1.1 Criteria
Time frame: From first dose until disease progression or treatment discontinuation (assessed up to January 2017, approximately 18 months)
ORR is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants. BOR is defined as the best response designation recorded between the first dose date and the date of progression per RECIST 1.1, or the date of subsequent anti-cancer therapy, whichever occurs first. CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD)=At least a 20% increase in the sum of diameters of target lesions, referencing the smallest sum on study, and an absolute increase of at least 5 mm, or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referencing the smallest sum diameters while on study.
Overall Survival (OS)
Time frame: From date of randomization to date of death (assessed up to study completion, approximately 18 months)
If a Phase 2 comparative study is initiated and, for PAC only: Overall Survival is defined as the time from randomization to date of death due to any cause.
Number of Participants With Laboratory Abnormalities
Time frame: From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months)
The number of participants who experienced on-study Grade 3 or 4 laboratory abnormalities (without Grade 3 or 4 abnormality at baseline) was reported for each arm.
Number of Participants With Electrocardiogram Abnormalities
Time frame: From first dose to date of last dose plus 30 days
The number of participants experiencing electrocardiogram abnormalities was reported for each arm
1 secondary outcome
Progression-Free Survival (PFS)
Time frame: From first dose to date of progression (assessed up to January 2017, approximately 18 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Solid Tumor
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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
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ulocuplumab and Nivolumab in people with Solid Tumor, run by Bristol-Myers Squibb at 7 sites in 2 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 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: stopped early, as of the sponsor's last update on 1 Nov 2018. 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, Finland. 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 29 Mar 2018). 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?
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Immune-mediated AEs (time frame: From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months)). The study lists 5 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 1 Nov 2018.