- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02472977
Safety and Efficacy Study of Ulocuplumab and Nivolumab in Subjects With Solid Tumors (CXCessoR4)
October 5, 2018 updated by: Bristol-Myers Squibb
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.
Study Overview
Detailed Description
- Intervention model: Single group for Stage 1 DLT, then Parallel
- Data Monitoring Committee: No (Stage 1) Yes (Stage 2 Randomized Ph2)
Study Type
Interventional
Enrollment (Actual)
61
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Helsinki, Finland, 00029
- Local Institution
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Colorado
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Aurora, Colorado, United States, 80045
- University Of Colorado Hosp
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University Health
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Maryland
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Baltimore, Maryland, United States, 21287
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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New York, New York, United States, 10032
- Columbia University Medical Center (Cumc)
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Utah
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Salt Lake City, Utah, United States, 84112
- Huntsman Cancer Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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ACTIVE_COMPARATOR: BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (SCLC)
Small cell lung cancer (SCLC)
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Other Names:
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ACTIVE_COMPARATOR: BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (PAC)
Pancreatic cancer (PAC)
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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)
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The number participants who experienced on-study AEs, SAEs, and AEs requiring immune modulating medication is reported.
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From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months)
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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)
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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.
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From first dose until disease progression or treatment discontinuation (assessed up to January 2017, approximately 18 months)
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Overall Survival (OS)
Time Frame: From date of randomization to date of death (assessed up to study completion, approximately 18 months)
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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.
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From date of randomization to date of death (assessed up to study completion, approximately 18 months)
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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)
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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.
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From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months)
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Number of Participants With Electrocardiogram Abnormalities
Time Frame: From first dose to date of last dose plus 30 days
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The number of participants experiencing electrocardiogram abnormalities was reported for each arm
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From first dose to date of last dose plus 30 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Progression-Free Survival (PFS)
Time Frame: From first dose to date of progression (assessed up to January 2017, approximately 18 months)
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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.
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From first dose to date of progression (assessed up to January 2017, approximately 18 months)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 13, 2015
Primary Completion (ACTUAL)
January 27, 2017
Study Completion (ACTUAL)
January 27, 2017
Study Registration Dates
First Submitted
June 12, 2015
First Submitted That Met QC Criteria
June 12, 2015
First Posted (ESTIMATE)
June 16, 2015
Study Record Updates
Last Update Posted (ACTUAL)
November 1, 2018
Last Update Submitted That Met QC Criteria
October 5, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CA212-115
- 2015-000136-15 (EUDRACT_NUMBER)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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