A Single-Arm, Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Treatment Containing an Anti-CTLA4 Monoclonal Antibody (CheckMate 172)
NCT ID: NCT02156804
Last Updated: 2020-09-11
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
1009 participants
INTERVENTIONAL
2014-10-07
2019-01-18
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.
Expanded Access Program With Nivolumab to Treat Melanoma
NCT02142218
Nivolumab Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Treatment for Patients With Advanced Melanoma
NCT02599402
A Study to Compare BMS-936558 to the Physician's Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4 Therapy (CheckMate 037)
NCT01721746
A Phase II Trial of Neoadjuvant Treatment With PD-1 Inhibition (Nivolumab) With or Without IDO Inhibition (BMS-986205) and With or Without CTLA-4 Inhibition (Ipilimumab) in Resectable Stage III or IV Melanoma
NCT04007588
An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma
NCT03329846
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.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nivolumab (BMS-936558)
Nivolumab (BMS-936558) Intravenous solution every 2 weeks
Nivolumab (BMS-936558)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nivolumab (BMS-936558)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS):
* PS 0 to 1
* PS 2
* Previously treated unresectable stage III or stage IV melanoma as per the American Joint Committee on Cancer 2010 Guidelines regardless of BRAF mutation status
* Subjects must have experienced evaluable Response Evaluation Criteria In Solid Tumors (RECIST 1.1)-defined disease progression
* Prior treatment with chemotherapy, interferon (adjuvant setting), Interleukin (IL-2), BRAF/MEK inhibitors for subjects with known BRAF mutations, Mitogen-activated or extracellular signal- regulated protein kinase (MEK) inhibitors for Neuroblastoma Ras Viral (v-ras) oncogene homolog (NRAS) mutations, and cKIT inhibitor subjects with known cKIT mutations are allowed
* Patients with CNS metastases are eligible:
* if CNS metastases are treated, patients are asymptomatic or neurologically returned to baseline
* if they have previously untreated CNS metastases and are asymptomatic
* if they have leptomeningeal metastases, are treated and asymptomatic or neurologically returned to baseline with life expectancy \> 3 months
* Patients with a known history of Grades 3-4 immune-related adverse reactions during/after anti-CTLA-4 therapy if all toxicities have resolved at least to Grade 1
Exclusion Criteria
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
Graz, , Austria
Local Institution
Innsbruck, , Austria
Local Institution
Salzburg, , Austria
Local Institution
Sankt Pölten, , Austria
Local Institution
Vienna, , Austria
Local Institution
Wein, , Austria
Institut Jules Bordet
Brussels, , Belgium
Universitair Ziekenhuis Brussel
Brussels, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Local Institution
Edegem, , Belgium
Local Institution
Ghent, , Belgium
Local Institution
Hasselt, , Belgium
Az Groeninge
Kortrijk, , Belgium
Local Institution
Leuven, , Belgium
Chu De Liege
Liège, , Belgium
Local Institution
Brno, , Czechia
Local Institution
Hradec Králové, , Czechia
Local Institution
Prague, , Czechia
Local Institution
Prague, , Czechia
Local Institution
Helsinki, , Finland
Local Institution
Jyväskylä, , Finland
Local Institution
Oulu, , Finland
Local Institution
Tampere, , Finland
Local Institution
Lübeck, Schleswig-Holstein, Germany
Local Institution
Augsburg, , Germany
Local Institution
Bochum, , Germany
Local Institution
Buxtehude, , Germany
Local Institution
Chemnitz, , Germany
Local Institution
Cologne, , Germany
Local Institution
Dessau, , Germany
Local Institution
Dresden, , Germany
Local Institution
Erfurt, , Germany
Local Institution
Erlangen, , Germany
Local Institution
Essen, , Germany
Local Institution
Frankfurt am Main, , Germany
Local Institution
Freiburg im Breisgau, , Germany
Local Institution
Gera, , Germany
Local Institution
Giessen, , Germany
Local Institution
Göttingen, , Germany
Local Institution
Hamburg, , Germany
Local Institution
Hanover, , Germany
Local Institution
Heidelberg, , Germany
Local Institution
Heilbronn, , Germany
Local Institution
Jena, , Germany
Local Institution
Kassel, , Germany
Local Institution
Kiel, , Germany
Local Institution
Leipzig, , Germany
Local Institution
Ludwigshafen, , Germany
Local Institution
Magdeburg, , Germany
Local Institution
Mainz, , Germany
Local Institution
Marburg, , Germany
Local Institution
Minden, , Germany
Local Institution
München, , Germany
Local Institution
München, , Germany
Local Institution
Münster, , Germany
Local Institution
Münster, , Germany
Local Institution
Nuremberg, , Germany
Local Institution
Quedlinburg, , Germany
Local Institution
Recklinghausen, , Germany
Local Institution
Regensburg, , Germany
Local Institution
Schwerin, , Germany
Local Institution
Traunstein, , Germany
Local Institution
Tübingen, , Germany
Local Institution
Wurzbug, , Germany
Local Institution
Heraklion, Crete, Greece
Local Institution
Athens, , Greece
Local Institution
Athens, , Greece
Local Institution
Thessaloniki, , Greece
Local Institution
Thessaloniki, , Greece
Local Institution
Budapest, , Hungary
Local Institution
Budapest, , Hungary
Local Institution
Debrecen, , Hungary
Local Institution
Pécs, , Hungary
Local Institution
Szeged, , Hungary
Local Institution
Szombathely, , Hungary
Local Institution
Wilton, CORK, Ireland
Local Institution
Dublin, , Ireland
Local Institution
Dublin, , Ireland
Local Institution
Dublin, , Ireland
Local Institution
Dublin, , Ireland
Local Institution
Galway, , Ireland
Local Institution
Waterford, , Ireland
Local Institution
Bari, , Italy
Local Institution
Bergamo, , Italy
Local Institution
Genova, , Italy
Local Institution
Meldola (FC), , Italy
Local Institution
Milan, , Italy
Local Institution
Milan, , Italy
Local Institution
Milan, , Italy
Local Institution
Napoli, , Italy
Local Institution
Padua, , Italy
Local Institution
Palermo, , Italy
Local Institution
Roma, , Italy
Local Institution
Roma, , Italy
Local Institution
Siena, , Italy
Local Institution
Terni, , Italy
Local Institution
Torino, , Italy
Local Institution
Luxembourg, , Luxembourg
Local Institution
Amsterdam, North Holland, Netherlands
Local Institution
Amsterdam, , Netherlands
Local Institution
Breda, , Netherlands
Local Institution
Enschede, , Netherlands
Local Institution
Groningen, , Netherlands
Local Institution
Leeuwarden, , Netherlands
Local Institution
Leiden, , Netherlands
Local Institution
Maastrict, , Netherlands
Local Institution
Nijmegen, , Netherlands
Local Institution
Rotterdam, , Netherlands
Local Institution
Sittard-Geleen, , Netherlands
Local Institution
Utrecht, , Netherlands
Local Institution
Veldhoven, , Netherlands
Local Institution
Zwolle, , Netherlands
Local Institution
Ålesund, , Norway
Local Institution
Bergen, , Norway
Local Institution
Oslo, , Norway
Local Institution
Bydgoszcz, , Poland
Local Institution
Gdansk, , Poland
Local Institution
Lodz, , Poland
Local Institution
Warsaw, , Poland
Local Institution
Lisbon, , Portugal
Local Institution
Porto, , Portugal
Local Institution
Bucharest, , Romania
Local Institution
Romania, , Romania
Local Institution
Moscow, , Russia
Local Institution
Saint Petersburg, , Russia
Local Institution
Saint Petersburg, , Russia
Local Institution
Albacete, , Spain
Local Institution
Barcelona, , Spain
Local Institution
Barcelona, , Spain
Local Institution
Barcelona, , Spain
Local Institution
Bilbao, , Spain
Local Institution
Donostia / San Sebastian, , Spain
Local Institution
Granada, , Spain
Local Institution
Las Palmas de Gran Canaria, , Spain
Local Institution
Madrid, , Spain
Local Institution
Madrid, , Spain
Local Institution
Madrid, , Spain
Hospital De Madrid, Norte Sanchinarro
Madrid, , Spain
Local Institution
Málaga, , Spain
Local Institution
Oviedo, , Spain
Local Institution
Palma de Mallorca, , Spain
Local Institution
Salamanca, , Spain
Hospital Clinico Univ. de Santiago-CHUS
Santiago de Compostela, , Spain
Local Institution
Seville, , Spain
Local Institution
Toledo, , Spain
Local Institution
Valencia, , Spain
Local Institution
Valencia, , Spain
Local Institution
Lund, , Sweden
Local Institution
Uppsala, , Sweden
Local Institution
Aarau, , Switzerland
Local Institution
Basel, , Switzerland
Local Institution
Bellinzona, , Switzerland
Local Institution
Chur, , Switzerland
Local Institution
Zurich, , Switzerland
Local Institution
Bristol, AVON, United Kingdom
Local Institution
Northwood, Middlesex, United Kingdom
Local Institution
Birmingham, , United Kingdom
Local Institution
Cambridge, , United Kingdom
Local Institution
Cottingham, , United Kingdom
Local Institution
Essex, , United Kingdom
Local Institution
Glasgow, , United Kingdom
Local Institution
London, , United Kingdom
Local Institution
Manchester, , United Kingdom
Local Institution
Metropolitan Borough of Wirral, , United Kingdom
Local Institution
Newcastle upon Tyne, , United Kingdom
Local Institution
Oxford, , United Kingdom
Local Institution
Southampton, , United Kingdom
Local Institution
Surrey, , United Kingdom
Local Institution
Swansea, , United Kingdom
Local Institution
Truro, , United Kingdom
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.
Schadendorf D, Ascierto PA, Haanen J, Espinosa E, Demidov L, Garbe C, Guida M, Lorigan P, Chiarion-Sileni V, Gogas H, Maio M, Fierro MT, Hoeller C, Terheyden P, Gutzmer R, Guren TK, Bafaloukos D, Rutkowski P, Plummer R, Waterston A, Kaatz M, Mandala M, Marquez-Rodas I, Munoz-Couselo E, Dummer R, Grigoryeva E, Young TC, Nathan P. Safety and efficacy of nivolumab in challenging subgroups with advanced melanoma who progressed on or after ipilimumab treatment: A single-arm, open-label, phase II study (CheckMate 172). Eur J Cancer. 2019 Nov;121:144-153. doi: 10.1016/j.ejca.2019.08.014. Epub 2019 Sep 30.
Nathan P, Ascierto PA, Haanen J, Espinosa E, Demidov L, Garbe C, Guida M, Lorigan P, Chiarion-Sileni V, Gogas H, Maio M, Fierro MT, Hoeller C, Terheyden P, Gutzmer R, Guren TK, Bafaloukos D, Rutkowski P, Plummer R, Waterston A, Kaatz M, Mandala M, Marquez-Rodas I, Munoz-Couselo E, Dummer R, Grigoryeva E, Young TC, Schadendorf D. Safety and efficacy of nivolumab in patients with rare melanoma subtypes who progressed on or after ipilimumab treatment: a single-arm, open-label, phase II study (CheckMate 172). Eur J Cancer. 2019 Sep;119:168-178. doi: 10.1016/j.ejca.2019.07.010. Epub 2019 Aug 21.
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 Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2014-001286-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-172
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.