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)

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

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.

Study Overview

• Status: Completed
• Conditions: Melanoma
• Intervention / Treatment: Drug: Nivolumab (BMS-936558)

• Study Type: Interventional
• Enrollment (Actual): 1009
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Local Institution
  • Innsbruck, Austria, 6020
    • Local Institution
  • Salzburg, Austria, 5020
    • Local Institution
  • St. Polten, Austria, 3100
    • Local Institution
  • Wein, Austria, 1090
    • Local Institution
  • Wien, Austria, 1030
    • Local Institution
• Belgium
  • Brussels, Belgium, 1090
    • Universitair Ziekenhuis Brussel
  • Bruxelles, Belgium, 1000
    • Institut Jules Bordet
  • Bruxelles, Belgium, 1200
    • Cliniques Universitaires Saint-luc
  • Edegem, Belgium, 2650
    • Local Institution
  • Gent, Belgium, 9000
    • Local Institution
  • Hasselt, Belgium, 3500
    • Local Institution
  • Kortrijk, Belgium, 8500
    • Az Groeninge
  • Leuven, Belgium, 3000
    • Local Institution
  • Liege, Belgium, 4000
    • CHU de Liege
• Czechia
  • Brno, Czechia, 656 53
    • Local Institution
  • Hradec Kralove, Czechia, 500 05
    • Local Institution
  • Praha 10, Czechia, 100 34
    • Local Institution
  • Praha 2, Czechia, 120 28
    • Local Institution
• Finland
  • Helsinki, Finland, 00290
    • Local Institution
  • Jyvaskyla, Finland, 40620
    • Local Institution
  • Oulu, Finland, 90220
    • Local Institution
  • Tampere, Finland, 33520
    • Local Institution
• Germany
  • Augsburg, Germany, 86156
    • Local Institution
  • Bochum, Germany, 44791
    • Local Institution
  • Buxtehude, Germany, 21614
    • Local Institution
  • Chemnitz, Germany, 09117
    • Local Institution
  • Dessau, Germany, 06847
    • Local Institution
  • Dresden, Germany, 01307
    • Local Institution
  • Erfurt, Germany, 99089
    • Local Institution
  • Erlangen, Germany, 91054
    • Local Institution
  • Essen, Germany, 45 122
    • Local Institution
  • Frankfurt Am Main, Germany, 60590
    • Local Institution
  • Freiburg, Germany, 79104
    • Local Institution
  • Gera, Germany, 07548
    • Local Institution
  • Giessen, Germany, 35385
    • Local Institution
  • Goettingen, Germany, 37075
    • Local Institution
  • Hamburg, Germany, 20253
    • Local Institution
  • Hannover, Germany, 30625
    • Local Institution
  • Heidelberg, Germany, 69120
    • Local Institution
  • Heilbronn, Germany, 74078
    • Local Institution
  • Jena, Germany, 07740
    • Local Institution
  • Kassel, Germany, 34125
    • Local Institution
  • Kiel, Germany, 24105
    • Local Institution
  • Koln, Germany, 50937
    • Local Institution
  • Leipzig, Germany, 04103
    • Local Institution
  • Ludwigshafen, Germany, 67063
    • Local Institution
  • Magdeburg, Germany, 39120
    • Local Institution
  • Mainz, Germany, 55131
    • Local Institution
  • Marburg, Germany, 35043
    • Local Institution
  • Minden, Germany, 32429
    • Local Institution
  • Muenster, Germany, 48149
    • Local Institution
  • Munchen, Germany, 80337
    • Local Institution
  • Munchen, Germany, 81675
    • Local Institution
  • Munster, Germany, 48157
    • Local Institution
  • Nuernberg, Germany, 90419
    • Local Institution
  • Quedlinburg, Germany, 06484
    • Local Institution
  • Recklinghausen, Germany, 45657
    • Local Institution
  • Regensburg, Germany, 93053
    • Local Institution
  • Schwerin, Germany, 19049
    • Local Institution
  • Traunstein, Germany, 83278
    • Local Institution
  • Tubingen, Germany, 72076
    • Local Institution
  • Wurzbug, Germany, 97080
    • Local Institution
  • Schleswig-holstein
    • Luebeck, Schleswig-holstein, Germany, 23538
      • Local Institution
• Greece
  • Athens, Greece, 11527
    • Local Institution
  • Athens, Greece, 18547
    • Local Institution
  • Thessaloniki, Greece, 54007
    • Local Institution
  • Thessaloniki, Greece, 57010
    • Local Institution
  • Creta
    • Heraklion, Creta, Greece, 71201
      • Local Institution
• Hungary
  • Budapest, Hungary, 1122
    • Local Institution
  • Budapest, Hungary, H-7085
    • Local Institution
  • Debrecen, Hungary, 4032
    • Local Institution
  • Pecs, Hungary, H-7632
    • Local Institution
  • Szeged, Hungary, H-6720
    • Local Institution
  • Szombathely, Hungary, 9700
    • Local Institution
• Ireland
  • Dublin, Ireland, 4
    • Local Institution
  • Dublin, Ireland, 8
    • Local Institution
  • Dublin, Ireland, 7
    • Local Institution
  • Dublin, Ireland, 9
    • Local Institution
  • Galway, Ireland
    • Local Institution
  • Waterford, Ireland, 9026
    • Local Institution
  • Cork
    • Wilton, Cork, Ireland
      • Local Institution
• Italy
  • Bari, Italy, 70124
    • Local Institution
  • Bergamo, Italy, 24127
    • Local Institution
  • Genova, Italy, 16132
    • Local Institution
  • Meldola (FC), Italy, 47014
    • Local Institution
  • Milano, Italy, 20141
    • Local Institution
  • Milano, Italy, 20132
    • Local Institution
  • Milano, Italy, 20133
    • Local Institution
  • Napoli, Italy, 80131
    • Local Institution
  • Padova, Italy, 35128
    • Local Institution
  • Palermo, Italy, 90127
    • Local Institution
  • Roma, Italy, 00144
    • Local Institution
  • Roma, Italy, 00167
    • Local Institution
  • Siena, Italy, 53100
    • Local Institution
  • Terni, Italy, 05100
    • Local Institution
  • Torino, Italy, 10137
    • Local Institution
• Luxembourg
  • Luxembourg, Luxembourg, 1210
    • Local Institution
• Netherlands
  • Amsterdam, Netherlands, 1066 CX
    • Local Institution
  • Breda, Netherlands, 4918 EV
    • Local Institution
  • Enschede, Netherlands, 7513 ER
    • Local Institution
  • Groningen, Netherlands, 9713 GZ
    • Local Institution
  • Leeuwarden, Netherlands, 8934 AD
    • Local Institution
  • Leiden, Netherlands, 2300 RC
    • Local Institution
  • Maastrict, Netherlands, 6229 HX
    • Local Institution
  • Nijmegen, Netherlands, 6525 GA
    • Local Institution
  • Rotterdam, Netherlands, 3075 EA
    • Local Institution
  • Sittard-Geleen, Netherlands, 6162 BG
    • Local Institution
  • Utrecht, Netherlands, 3584 CX
    • Local Institution
  • Veldhoven, Netherlands, 5504 DB
    • Local Institution
  • Zwolle, Netherlands, 8025-AB
    • Local Institution
  • Noord-holland
    • Amsterdam, Noord-holland, Netherlands, 1081 HZ
      • Local Institution
• Norway
  • Alesund, Norway, 6017
    • Local Institution
  • Bergen, Norway, 5021
    • Local Institution
  • Oslo, Norway, 0310
    • Local Institution
• Poland
  • Bydgoszcz, Poland, 85-796
    • Local Institution
  • Gdansk, Poland, 80-952
    • Local Institution
  • Lodz, Poland, 93-513
    • Local Institution
  • Warszawa, Poland, 02781
    • Local Institution
• Portugal
  • Lisboa, Portugal, 1099-023
    • Local Institution
  • Porto, Portugal, 4200-072
    • Local Institution
• Romania
  • Bucharest, Romania, 022328
    • Local Institution
  • Romania, Romania, 400015
    • Local Institution
• Russian Federation
  • Moscow, Russian Federation, 115478
    • Local Institution
  • St. Petersburg, Russian Federation, 197022
    • Local Institution
  • St. Petersburg, Russian Federation, 197758
    • Local Institution
• Spain
  • Albacete, Spain, 02006
    • Local Institution
  • Barcelona, Spain, 08035
    • Local Institution
  • Barcelona, Spain, 08036
    • Local Institution
  • Barcelona, Spain, 08908
    • Local Institution
  • Bilbao, Spain, 48013
    • Local Institution
  • Granada, Spain, 18014
    • Local Institution
  • Las Palmas de Gran Canaria, Spain, 35016
    • Local Institution
  • Madrid, Spain, 28041
    • Local Institution
  • Madrid, Spain, 28007
    • Local Institution
  • Madrid, Spain, 28046
    • Local Institution
  • Madrid, Spain, 28050
    • Hospital De Madrid, Norte Sanchinarro
  • Malaga, Spain, 29010
    • Local Institution
  • Oviedo, Spain, 33011
    • Local Institution
  • Palma de Mallorca, Spain, 07010
    • Local Institution
  • Salamanca, Spain, 37007
    • Local Institution
  • San Sebastian, Spain, 20014
    • Local Institution
  • Santiago de Compostela, Spain, 15706
    • Hospital Clinico Univ. de Santiago-CHUS
  • Sevilla, Spain, 41071
    • Local Institution
  • Toledo, Spain, 45071
    • Local Institution
  • Valencia, Spain, 46009
    • Local Institution
  • Valencia, Spain, 46026
    • Local Institution
• Sweden
  • Lund, Sweden, 221 85
    • Local Institution
  • Uppsala, Sweden, 751 85
    • Local Institution
• Switzerland
  • Aarau, Switzerland, 5001
    • Local Institution
  • Basel, Switzerland, 4031
    • Local Institution
  • Bellinzona, Switzerland, 6501
    • Local Institution
  • Chur, Switzerland, 7000
    • Local Institution
  • Zurich, Switzerland, 8091
    • Local Institution
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • Local Institution
  • Cambridge, United Kingdom, CB2 0QQ
    • Local Institution
  • Cottingham, United Kingdom, HU16 5JQ
    • Local Institution
  • Essex, United Kingdom
    • Local Institution
  • Glasgow, United Kingdom, G12 0YN
    • Local Institution
  • London, United Kingdom, SE1 9RT
    • Local Institution
  • Manchester, United Kingdom, M20 4BX
    • Local Institution
  • Newcastle Upon Tyne, United Kingdom, NE7 7DN
    • Local Institution
  • Oxford, United Kingdom, OX3 7LE
    • Local Institution
  • Southampton, United Kingdom, SO16 6YD
    • Local Institution
  • Surrey, United Kingdom, SM2 5PT
    • Local Institution
  • Swansea, United Kingdom, SA2 8QA
    • Local Institution
  • Truro, United Kingdom, TR1 3LJ
    • Local Institution
  • Wirral, United Kingdom, CH63 4JY
    • Local Institution
  • Avon
    • Bristol, Avon, United Kingdom, BS2 8ED
      • Local Institution
  • Middlesex
    • Northwood, Middlesex, United Kingdom, HA6 2RN
      • Local Institution

Participation Criteria

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:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nivolumab (BMS-936558); Nivolumab (BMS-936558) Intravenous solution every 2 weeks	Drug: Nivolumab (BMS-936558)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Incidence of All High-grade (Grades 3 and Higher), Select Adverse Events	The number of Participants who reported high-grade (CTCAE v4.0 Grade 3 or higher), select AEs were summarized using the all treated analysis set by system organ class and MedDRA preferred term.	Up to 2 years
Median Time to Onset (Grades 3-4) of Select Adverse Events	Select AEs were summarized according to their incidence as well as their time to onset.	Up to 2 years.
Median Time to Resolution (Grades 3-4) of Select Adverse Events	Select AEs were summarized according to their incidence as well as their time to resolution	Up to 2 years
Overall Survival	The time from first dosing date to the date of death.	Up to 4 years

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2014
• Primary Completion (Actual): January 18, 2019
• Study Completion (Actual): January 18, 2019

Study Registration Dates

• First Submitted: May 29, 2014
• First Submitted That Met QC Criteria: June 2, 2014
• First Posted (Estimate): June 5, 2014

Study Record Updates

• Last Update Posted (Actual): September 11, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab
• Other Study ID Numbers: CA209-172; 2014-001286-28 (EudraCT Number)