Safety and Efficacy Study of Ulocuplumab and Nivolumab in Subjects With Solid Tumors
NCT ID: NCT02472977
Last Updated: 2018-11-01
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1/PHASE2
61 participants
INTERVENTIONAL
2015-07-13
2017-01-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Nivolumab in Treating Patients With Advanced Metastatic Non-small Cell Lung Cancer
NCT03121417
An Investigational Immuno-therapy Study to Test Combination Treatments in Patients With Advanced Non-Small Cell Lung Cancer
NCT02750514
A Safety Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Non-small Cell Lung Cancer
NCT03048136
Ipilimumab and Nivolumab in Patients With Anti-PD-1-axis Therapy-resistant Advanced Non-small Cell Lung Cancer.
NCT03262779
An Investigational Immuno-therapy Study for Safety of Nivolumab in Combination With Ipilimumab to Treat Advanced Cancers
NCT02869789
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Data Monitoring Committee: No (Stage 1) Yes (Stage 2 Randomized Ph2)
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (SCLC)
Small cell lung cancer (SCLC)
Ulocuplumab
Nivolumab
BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (PAC)
Pancreatic cancer (PAC)
Ulocuplumab
Nivolumab
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ulocuplumab
Nivolumab
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Active, known or suspected autoimmune disease
* Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Of Colorado Hosp
Aurora, Colorado, United States
Indiana University Health
Indianapolis, Indiana, United States
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, United States
Columbia University Medical Center (Cumc)
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Local Institution
Helsinki, , Finland
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
Access external resources that provide additional context or updates about the study.
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-000136-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA212-115
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.