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)

NCT02156804 | Completed Phase 2 Results

• 2 other identifiers: CA209-1722014-001286-28
• Study Type: interventional
• Target: 1,009
• Locations: 20 countries
• Sites: 170

Brief Summary

The purpose of this study is to determine the rate and frequency of high-grade (CTCAE v4.0 Grade 3 or higher), treatment-related, select adverse events in subjects with histologically confirmed stage III (unresectable) or stage IV melanoma and progression post prior treatment containing an anti-Cytotoxic T Lymphocyte Antigen (CTLA-4) monoclonal antibody, treated with Nivolumab (BMS-936558) at a dose of 3 mg/kg every two weeks.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• the Incidence of Highgrade (CTCAE v4.0 Grade 3 or Higher), Treatment Related,Select Adverse Events.

  The number of participants who reported high-grade (CTCAE v4.0 Grade 3 or higher), treatment-related, select AEs (pulmonary,gastrointestinal, skin, renal, hepatic, endocrine) were summarized using the all treated analysis set by system organ class and Medical Dictionary for Regulatory (MedDRA) preferred term.

  Up to 2 years

Secondary Outcomes (4)

• The Incidence of All High-grade (Grades 3 and Higher), Select Adverse Events

  Up to 2 years

• Median Time to Onset (Grades 3-4) of Select Adverse Events

  Up to 2 years.

• Median Time to Resolution (Grades 3-4) of Select Adverse Events

  Up to 2 years

• Overall Survival

  Up to 4 years

Study Arms (1)

Nivolumab (BMS-936558)

EXPERIMENTAL

Nivolumab (BMS-936558) Intravenous solution every 2 weeks

Drug: Nivolumab (BMS-936558)

Interventions

Nivolumab (BMS-936558) DRUG

Nivolumab (BMS-936558)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with histologically confirmed malignant melanoma
• 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

You may not qualify if:

• Subjects with untreated, active Central Nervous System (CNS) metastases are excluded

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (170)

Local Institution

Graz, 8036, Austria

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Innsbruck, 6020, Austria

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Salzburg, 5020, Austria

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Sankt Pölten, 3100, Austria

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Vienna, 1030, Austria

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Wein, 1090, Austria

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Institut Jules Bordet

Brussels, 1000, Belgium

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Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

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Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

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Edegem, 2650, Belgium

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Ghent, 9000, Belgium

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Hasselt, 3500, Belgium

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Az Groeninge

Kortrijk, 8500, Belgium

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Leuven, 3000, Belgium

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Chu De Liege

Liège, 4000, Belgium

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Brno, 656 53, Czechia

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Hradec Králové, 500 05, Czechia

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Prague, 100 34, Czechia

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Prague, 120 28, Czechia

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Helsinki, 00290, Finland

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Jyväskylä, 40620, Finland

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Oulu, 90220, Finland

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Tampere, 33520, Finland

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Lübeck, Schleswig-Holstein, 23538, Germany

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Augsburg, 86156, Germany

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Bochum, 44791, Germany

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Buxtehude, 21614, Germany

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Chemnitz, 09117, Germany

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Cologne, 50937, Germany

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Dessau, 06847, Germany

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Dresden, 01307, Germany

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Erfurt, 99089, Germany

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Erlangen, 91054, Germany

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Essen, 45 122, Germany

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Frankfurt am Main, 60590, Germany

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Freiburg im Breisgau, 79104, Germany

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Gera, 07548, Germany

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Giessen, 35385, Germany

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Göttingen, 37075, Germany

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Hamburg, 20253, Germany

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Hanover, 30625, Germany

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Heidelberg, 69120, Germany

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Heilbronn, 74078, Germany

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Jena, 07740, Germany

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Kassel, 34125, Germany

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Kiel, 24105, Germany

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Leipzig, 04103, Germany

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Ludwigshafen, 67063, Germany

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Magdeburg, 39120, Germany

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Mainz, 55131, Germany

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Marburg, 35043, Germany

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Minden, 32429, Germany

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München, 80337, Germany

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München, 81675, Germany

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Münster, 48149, Germany

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Münster, 48157, Germany

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Nuremberg, 90419, Germany

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Quedlinburg, 06484, Germany

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Recklinghausen, 45657, Germany

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Regensburg, 93053, Germany

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Schwerin, 19049, Germany

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Traunstein, 83278, Germany

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Tübingen, 72076, Germany

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Wurzbug, 97080, Germany

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Heraklion, Crete, 71201, Greece

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Athens, 11527, Greece

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Athens, 18547, Greece

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Thessaloniki, 54007, Greece

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Thessaloniki, 57010, Greece

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Budapest, 1122, Hungary

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Budapest, H-7085, Hungary

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Debrecen, 4032, Hungary

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Pécs, H-7632, Hungary

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Szeged, H-6720, Hungary

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Szombathely, 9700, Hungary

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Wilton, CORK, Ireland

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Dublin, 4, Ireland

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Dublin, 7, Ireland

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Dublin, 8, Ireland

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Dublin, 9, Ireland

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Galway, Ireland

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Waterford, 9026, Ireland

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Bari, 70124, Italy

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Bergamo, 24127, Italy

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Genova, 16132, Italy

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Meldola (FC), 47014, Italy

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Milan, 20132, Italy

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Milan, 20133, Italy

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Milan, 20141, Italy

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Napoli, 80131, Italy

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Padua, 35128, Italy

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Palermo, 90127, Italy

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Roma, 00144, Italy

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Roma, 00167, Italy

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Siena, 53100, Italy

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Terni, 05100, Italy

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Torino, 10137, Italy

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Luxembourg, 1210, Luxembourg

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Amsterdam, North Holland, 1081 HZ, Netherlands

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Amsterdam, 1066 CX, Netherlands

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Breda, 4918 EV, Netherlands

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Enschede, 7513 ER, Netherlands

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Groningen, 9713 GZ, Netherlands

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Leeuwarden, 8934 AD, Netherlands

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Leiden, 2300 RC, Netherlands

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Maastrict, 6229 HX, Netherlands

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Nijmegen, 6525 GA, Netherlands

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Rotterdam, 3075 EA, Netherlands

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Sittard-Geleen, 6162 BG, Netherlands

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Utrecht, 3584 CX, Netherlands

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Veldhoven, 5504 DB, Netherlands

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Zwolle, 8025-AB, Netherlands

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Ålesund, 6017, Norway

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Bergen, 5021, Norway

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Oslo, 0310, Norway

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Bydgoszcz, 85-796, Poland

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Gdansk, 80-952, Poland

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Lodz, 93-513, Poland

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Warsaw, 02781, Poland

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Lisbon, 1099-023, Portugal

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Porto, 4200-072, Portugal

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Bucharest, 022328, Romania

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Romania, 400015, Romania

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Moscow, 115478, Russia

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Saint Petersburg, 197022, Russia

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Saint Petersburg, 197758, Russia

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Albacete, 02006, Spain

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Barcelona, 08035, Spain

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Barcelona, 08036, Spain

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Barcelona, 08908, Spain

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Bilbao, 48013, Spain

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Donostia / San Sebastian, 20014, Spain

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Granada, 18014, Spain

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Las Palmas de Gran Canaria, 35016, Spain

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Madrid, 28007, Spain

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Madrid, 28041, Spain

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Madrid, 28046, Spain

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Hospital De Madrid, Norte Sanchinarro

Madrid, 28050, Spain

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Málaga, 29010, Spain

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Oviedo, 33011, Spain

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Palma de Mallorca, 07010, Spain

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Salamanca, 37007, Spain

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Hospital Clinico Univ. de Santiago-CHUS

Santiago de Compostela, 15706, Spain

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Seville, 41071, Spain

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Toledo, 45071, Spain

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Valencia, 46009, Spain

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Valencia, 46026, Spain

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Lund, 221 85, Sweden

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Uppsala, 751 85, Sweden

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Aarau, 5001, Switzerland

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Basel, 4031, Switzerland

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Bellinzona, 6501, Switzerland

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Chur, 7000, Switzerland

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Zurich, 8091, Switzerland

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Bristol, AVON, BS2 8ED, United Kingdom

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Northwood, Middlesex, HA6 2RN, United Kingdom

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Birmingham, B15 2TH, United Kingdom

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Cambridge, CB2 0QQ, United Kingdom

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Cottingham, HU16 5JQ, United Kingdom

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Essex, United Kingdom

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Glasgow, G12 0YN, United Kingdom

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London, SE1 9RT, United Kingdom

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Manchester, M20 4BX, United Kingdom

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Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

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Newcastle upon Tyne, NE7 7DN, United Kingdom

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Oxford, OX3 7LE, United Kingdom

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Southampton, SO16 6YD, United Kingdom

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Surrey, SM2 5PT, United Kingdom

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Swansea, SA2 8QA, United Kingdom

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Truro, TR1 3LJ, United Kingdom

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Related Publications (2)

• 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.

  PMID: 31581055 DERIVED

• 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.

  PMID: 31445199 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Melanoma

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2014
• First Posted: June 5, 2014
• Study Start: October 7, 2014
• Primary Completion: January 18, 2019
• Study Completion: January 18, 2019
• Last Updated: September 11, 2020
• Results First Posted: February 20, 2020

Record last verified: 2020-09

Locations

IE (7); PL (4); LU (1); AU (6); FI (4); CH (5); GR (5); RO (2); RU (3); SE (2); DE (41); GB (16); HU (6); BE (9); IT (15); NO (3); PT (2); CZ (4); ES (21); NL (14)