Clinical trial NCT02156804: 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)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-06-05
Enrollment: 1009
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: the Incidence of Highgrade (CTCAE v4.0 Grade 3 or Higher), Treatment Related,Select Adverse Events.
timeFrame: Up to 2 years
Secondary outcomes:
measure: The Incidence of All High-grade (Grades 3 and Higher), Select Adverse Events
timeFrame: Up to 2 years
measure: Median Time to Onset (Grades 3-4) of Select Adverse Events
timeFrame: Up to 2 years.
measure: Median Time to Resolution (Grades 3-4) of Select Adverse Events
timeFrame: Up to 2 years
measure: Overall Survival
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Local Institution
city: Innsbruck
country: Austria
facility: Local Institution
city: Salzburg
country: Austria
facility: Local Institution
city: St. Polten
country: Austria
facility: Local Institution
city: Wein
country: Austria
facility: Local Institution
city: Wien
country: Austria
facility: Local Institution
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Bruxelles
country: Belgium
facility: Institut Jules Bordet
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Edegem
country: Belgium
facility: Local Institution
city: Gent
country: Belgium
facility: Local Institution
city: Hasselt
country: Belgium
facility: Local Institution
city: Kortrijk
country: Belgium
facility: Az Groeninge
city: Leuven
country: Belgium
facility: Local Institution
city: Liege
country: Belgium
facility: Chu De Liege
city: Brno
country: Czechia
facility: Local Institution
city: Hradec Kralove
country: Czechia
facility: Local Institution
city: Praha 10
country: Czechia
facility: Local Institution
city: Praha 2
country: Czechia
facility: Local Institution
city: Helsinki
country: Finland
facility: Local Institution
city: Jyvaskyla
country: Finland
facility: Local Institution
city: Oulu
country: Finland
facility: Local Institution
city: Tampere
country: Finland
facility: Local Institution
city: Luebeck
country: Germany
facility: Local Institution
state: Schleswig-holstein
city: Augsburg
country: Germany
facility: Local Institution
city: Bochum
country: Germany
facility: Local Institution
city: Buxtehude
country: Germany
facility: Local Institution
city: Chemnitz
country: Germany
facility: Local Institution
city: Dessau
country: Germany
facility: Local Institution
city: Dresden
country: Germany
facility: Local Institution
city: Erfurt
country: Germany
facility: Local Institution
city: Erlangen
country: Germany
facility: Local Institution
city: Essen
country: Germany
facility: Local Institution
city: Frankfurt Am Main
country: Germany
facility: Local Institution
city: Freiburg
country: Germany
facility: Local Institution
city: Gera
country: Germany
facility: Local Institution
city: Giessen
country: Germany
facility: Local Institution
city: Goettingen
country: Germany
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Hannover
country: Germany
facility: Local Institution
city: Heidelberg
country: Germany
facility: Local Institution
city: Heilbronn
country: Germany
facility: Local Institution
city: Jena
country: Germany
facility: Local Institution
city: Kassel
country: Germany
facility: Local Institution
city: Kiel
country: Germany
facility: Local Institution
city: Koln
country: Germany
facility: Local Institution
city: Leipzig
country: Germany
facility: Local Institution
city: Ludwigshafen
country: Germany
facility: Local Institution
city: Magdeburg
country: Germany
facility: Local Institution
city: Mainz
country: Germany
facility: Local Institution
city: Marburg
country: Germany
facility: Local Institution
city: Minden
country: Germany
facility: Local Institution
city: Muenster
country: Germany
facility: Local Institution
city: Munchen
country: Germany
facility: Local Institution
city: Munchen
country: Germany
facility: Local Institution
city: Munster
country: Germany
facility: Local Institution
city: Nuernberg
country: Germany
facility: Local Institution
city: Quedlinburg
country: Germany
facility: Local Institution
city: Recklinghausen
country: Germany
facility: Local Institution
city: Regensburg
country: Germany
facility: Local Institution
city: Schwerin
country: Germany
facility: Local Institution
city: Traunstein
country: Germany
facility: Local Institution
city: Tubingen
country: Germany
facility: Local Institution
city: Wurzbug
country: Germany
facility: Local Institution
city: Heraklion
country: Greece
facility: Local Institution
state: Creta
city: Athens
country: Greece
facility: Local Institution
city: Athens
country: Greece
facility: Local Institution
city: Thessaloniki
country: Greece
facility: Local Institution
city: Thessaloniki
country: Greece
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Debrecen
country: Hungary
facility: Local Institution
city: Pecs
country: Hungary
facility: Local Institution
city: Szeged
country: Hungary
facility: Local Institution
city: Szombathely
country: Hungary
facility: Local Institution
city: Wilton
country: Ireland
facility: Local Institution
state: Cork
city: Dublin
country: Ireland
facility: Local Institution
city: Dublin
country: Ireland
facility: Local Institution
city: Dublin
country: Ireland
facility: Local Institution
city: Dublin
country: Ireland
facility: Local Institution
city: Galway
country: Ireland
facility: Local Institution
city: Waterford
country: Ireland
facility: Local Institution
city: Bari
country: Italy
facility: Local Institution
city: Bergamo
country: Italy
facility: Local Institution
city: Genova
country: Italy
facility: Local Institution
city: Meldola (FC)
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Napoli
country: Italy
facility: Local Institution
city: Padova
country: Italy
facility: Local Institution
city: Palermo
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Siena
country: Italy
facility: Local Institution
city: Terni
country: Italy
facility: Local Institution
city: Torino
country: Italy
facility: Local Institution
city: Luxembourg
country: Luxembourg
facility: Local Institution
city: Amsterdam
country: Netherlands
facility: Local Institution
state: Noord-holland
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Breda
country: Netherlands
facility: Local Institution
city: Enschede
country: Netherlands
facility: Local Institution
city: Groningen
country: Netherlands
facility: Local Institution
city: Leeuwarden
country: Netherlands
facility: Local Institution
city: Leiden
country: Netherlands
facility: Local Institution
city: Maastrict
country: Netherlands
facility: Local Institution
city: Nijmegen
country: Netherlands
facility: Local Institution
city: Rotterdam
country: Netherlands
facility: Local Institution
city: Sittard-Geleen
country: Netherlands
facility: Local Institution
city: Utrecht
country: Netherlands
facility: Local Institution
city: Veldhoven
country: Netherlands
facility: Local Institution
city: Zwolle
country: Netherlands
facility: Local Institution
city: Alesund
country: Norway
facility: Local Institution
city: Bergen
country: Norway
facility: Local Institution
city: Oslo
country: Norway
facility: Local Institution
city: Bydgoszcz
country: Poland
facility: Local Institution
city: Gdansk
country: Poland
facility: Local Institution
city: Lodz
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Lisboa
country: Portugal
facility: Local Institution
city: Porto
country: Portugal
facility: Local Institution
city: Bucharest
country: Romania
facility: Local Institution
city: Romania
country: Romania
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
city: Albacete
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Bilbao
country: Spain
facility: Local Institution
city: Granada
country: Spain
facility: Local Institution
city: Las Palmas de Gran Canaria
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Hospital De Madrid, Norte Sanchinarro
city: Malaga
country: Spain
facility: Local Institution
city: Oviedo
country: Spain
facility: Local Institution
city: Palma de Mallorca
country: Spain
facility: Local Institution
city: Salamanca
country: Spain
facility: Local Institution
city: San Sebastian
country: Spain
facility: Local Institution
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Univ. de Santiago-CHUS
city: Sevilla
country: Spain
facility: Local Institution
city: Toledo
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
city: Lund
country: Sweden
facility: Local Institution
city: Uppsala
country: Sweden
facility: Local Institution
city: Aarau
country: Switzerland
facility: Local Institution
city: Basel
country: Switzerland
facility: Local Institution
city: Bellinzona
country: Switzerland
facility: Local Institution
city: Chur
country: Switzerland
facility: Local Institution
city: Zurich
country: Switzerland
facility: Local Institution
city: Bristol
country: United Kingdom
facility: Local Institution
state: Avon
city: Northwood
country: United Kingdom
facility: Local Institution
state: Middlesex
city: Birmingham
country: United Kingdom
facility: Local Institution
city: Cambridge
country: United Kingdom
facility: Local Institution
city: Cottingham
country: United Kingdom
facility: Local Institution
city: Essex
country: United Kingdom
facility: Local Institution
city: Glasgow
country: United Kingdom
facility: Local Institution
city: London
country: United Kingdom
facility: Local Institution
city: Manchester
country: United Kingdom
facility: Local Institution
city: Newcastle Upon Tyne
country: United Kingdom
facility: Local Institution
city: Oxford
country: United Kingdom
facility: Local Institution
city: Southampton
country: United Kingdom
facility: Local Institution
city: Surrey
country: United Kingdom
facility: Local Institution
city: Swansea
country: United Kingdom
facility: Local Institution
city: Truro
country: United Kingdom
facility: Local Institution
city: Wirral
country: United Kingdom
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.