A Study to Test Combination Treatments in People With Advanced Renal Cell Carcinoma
NCT ID: NCT02996110
Last Updated: 2022-12-19
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.
COMPLETED
PHASE2
182 participants
INTERVENTIONAL
2017-02-02
2021-11-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nivolumab + Ipilimumab
Nivolumab + Ipilimumab
Nivolumab
Specified Dose on Specified Days
Ipilimumab
Specified Dose on Specified Days
Nivolumab + Relatlimab
Nivolumab + Relatlimab
Nivolumab
Specified Dose on Specified Days
Relatlimab
Specified Dose on Specified Days
Nivolumab + BMS-986205
Nivolumab + BMS-986205
Nivolumab
Specified Dose on Specified Days
BMS-986205
Specified Dose on Specified Days
Nivolumab + BMS-813160
Nivolumab + BMS-813160 (CCR2/5 dual antagonist)
Nivolumab
Specified Dose on Specified Days
BMS-813160
Specified Dose on Specified Days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nivolumab
Specified Dose on Specified Days
Ipilimumab
Specified Dose on Specified Days
Relatlimab
Specified Dose on Specified Days
BMS-986205
Specified Dose on Specified Days
BMS-813160
Specified Dose on Specified Days
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
* Must have at least 1 lesion with measurable disease
* Life expectancy of at least 3 months
* Karnofsky Performance Status (KPS) must be =\>70%
Exclusion Criteria
* Patients/subjects with autoimmune disease
* Patients/subjects who need daily oxygen therapy
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.
Local Institution - 0037
New Haven, Connecticut, United States
Local Institution
Tampa, Florida, United States
Local Institution - 0031
Augusta, Georgia, United States
Local Institution - 0006
Chicago, Illinois, United States
Local Institution - 0007
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Local Institution - 0011
Detroit, Michigan, United States
Local Institution - 0008
St Louis, Missouri, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Local Institution - 0005
New York, New York, United States
Local Institution - 0043
Charlotte, North Carolina, United States
Local Institution - 0014
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Local Institution - 0002
Allentown, Pennsylvania, United States
Hollings Cancer Center
Charleston, South Carolina, United States
Local Institution - 0025
Nashville, Tennessee, United States
Ut Southwestern Medical Center
Dallas, Texas, United States
Local Institution - 0024
Charlottesville, Virginia, United States
University of Washington - Seattle Cancer Care Alliance
Seattle, Washington, United States
Local Institution - 0032
Westmead, New South Wales, Australia
Monash Medical Centre Clayton
Bentleigh, Victoria, Australia
Local Institution - 0044
Linz, Upper Austria, Austria
Local Institution - 0038
Hamilton, Ontario, Canada
Local Institution - 0029
Oshawa, Ontario, Canada
Local Institution - 0035
Toronto, Ontario, Canada
Local Institution - 0034
Montreal, Quebec, Canada
Local Institution - 0030
Québec, Quebec, Canada
Local Institution
Haifa, , Israel
Local Institution
Ramat Gan, , Israel
Local Institution - 0010
Milan, , Italy
Local Institution - 0012
Napoli, , Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Choueiri TK, Kluger H, George S, Tykodi SS, Kuzel TM, Perets R, Nair S, Procopio G, Carducci MA, Castonguay V, Folefac E, Lee CH, Hotte SJ, Miller WH Jr, Saggi SS, Lee CW, Desilva H, Bhagavatheeswaran P, Motzer RJ, Escudier B. FRACTION-RCC: nivolumab plus ipilimumab for advanced renal cell carcinoma after progression on immuno-oncology therapy. J Immunother Cancer. 2022 Nov;10(11):e005780. doi: 10.1136/jitc-2022-005780.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2016-003082-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA018-005
Identifier Type: -
Identifier Source: org_study_id