Back to resultsA 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)
Primary Purpose
Melanoma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Nivolumab (BMS-936558)
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma
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
Sites / Locations
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Universitair Ziekenhuis Brussel
- Institut Jules Bordet
- Cliniques Universitaires Saint-Luc
- Local Institution
- Local Institution
- Local Institution
- Az Groeninge
- Local Institution
- Chu De Liege
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Hospital De Madrid, Norte Sanchinarro
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Hospital Clinico Univ. de Santiago-CHUS
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nivolumab (BMS-936558)
Arm Description
Nivolumab (BMS-936558) Intravenous solution every 2 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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
Overall Survival
The time from first dosing date to the date of death.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02156804
Brief 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 (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
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 7, 2014 (Actual)
Primary Completion Date
January 18, 2019 (Actual)
Study Completion Date
January 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1009 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nivolumab (BMS-936558)
Arm Type
Experimental
Arm Description
Nivolumab (BMS-936558) Intravenous solution every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Nivolumab (BMS-936558)
Primary Outcome Measure Information:
Title
the Incidence of Highgrade (CTCAE v4.0 Grade 3 or Higher), Treatment Related,Select Adverse Events.
Description
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.
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
The Incidence of All High-grade (Grades 3 and Higher), Select Adverse Events
Description
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.
Time Frame
Up to 2 years
Title
Median Time to Onset (Grades 3-4) of Select Adverse Events
Description
Select AEs were summarized according to their incidence as well as their time to onset.
Time Frame
Up to 2 years.
Title
Median Time to Resolution (Grades 3-4) of Select Adverse Events
Description
Select AEs were summarized according to their incidence as well as their time to resolution
Time Frame
Up to 2 years
Title
Overall Survival
Description
The time from first dosing date to the date of death.
Time Frame
Up to 4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Local Institution
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Local Institution
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Local Institution
City
St. Polten
ZIP/Postal Code
3100
Country
Austria
Facility Name
Local Institution
City
Wein
ZIP/Postal Code
1090
Country
Austria
Facility Name
Local Institution
City
Wien
ZIP/Postal Code
1030
Country
Austria
Facility Name
Universitair Ziekenhuis Brussel
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Institut Jules Bordet
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Local Institution
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Local Institution
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Local Institution
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Az Groeninge
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
Local Institution
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Chu De Liege
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Local Institution
City
Brno
ZIP/Postal Code
656 53
Country
Czechia
Facility Name
Local Institution
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Local Institution
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Local Institution
City
Praha 2
ZIP/Postal Code
120 28
Country
Czechia
Facility Name
Local Institution
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Local Institution
City
Jyvaskyla
ZIP/Postal Code
40620
Country
Finland
Facility Name
Local Institution
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
Local Institution
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Local Institution
City
Luebeck
State/Province
Schleswig-holstein
ZIP/Postal Code
23538
Country
Germany
Facility Name
Local Institution
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Facility Name
Local Institution
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Local Institution
City
Buxtehude
ZIP/Postal Code
21614
Country
Germany
Facility Name
Local Institution
City
Chemnitz
ZIP/Postal Code
09117
Country
Germany
Facility Name
Local Institution
City
Dessau
ZIP/Postal Code
06847
Country
Germany
Facility Name
Local Institution
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Local Institution
City
Erfurt
ZIP/Postal Code
99089
Country
Germany
Facility Name
Local Institution
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Local Institution
City
Essen
ZIP/Postal Code
45 122
Country
Germany
Facility Name
Local Institution
City
Frankfurt Am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Local Institution
City
Freiburg
ZIP/Postal Code
79104
Country
Germany
Facility Name
Local Institution
City
Gera
ZIP/Postal Code
07548
Country
Germany
Facility Name
Local Institution
City
Giessen
ZIP/Postal Code
35385
Country
Germany
Facility Name
Local Institution
City
Goettingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Local Institution
City
Hamburg
ZIP/Postal Code
20253
Country
Germany
Facility Name
Local Institution
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Local Institution
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Local Institution
City
Heilbronn
ZIP/Postal Code
74078
Country
Germany
Facility Name
Local Institution
City
Jena
ZIP/Postal Code
07740
Country
Germany
Facility Name
Local Institution
City
Kassel
ZIP/Postal Code
34125
Country
Germany
Facility Name
Local Institution
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Local Institution
City
Koln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Local Institution
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Local Institution
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
Local Institution
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Local Institution
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Local Institution
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Local Institution
City
Minden
ZIP/Postal Code
32429
Country
Germany
Facility Name
Local Institution
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Local Institution
City
Munchen
ZIP/Postal Code
80337
Country
Germany
Facility Name
Local Institution
City
Munchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Local Institution
City
Munster
ZIP/Postal Code
48157
Country
Germany
Facility Name
Local Institution
City
Nuernberg
ZIP/Postal Code
90419
Country
Germany
Facility Name
Local Institution
City
Quedlinburg
ZIP/Postal Code
06484
Country
Germany
Facility Name
Local Institution
City
Recklinghausen
ZIP/Postal Code
45657
Country
Germany
Facility Name
Local Institution
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Local Institution
City
Schwerin
ZIP/Postal Code
19049
Country
Germany
Facility Name
Local Institution
City
Traunstein
ZIP/Postal Code
83278
Country
Germany
Facility Name
Local Institution
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Local Institution
City
Wurzbug
ZIP/Postal Code
97080
Country
Germany
Facility Name
Local Institution
City
Heraklion
State/Province
Creta
ZIP/Postal Code
71201
Country
Greece
Facility Name
Local Institution
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Local Institution
City
Athens
ZIP/Postal Code
18547
Country
Greece
Facility Name
Local Institution
City
Thessaloniki
ZIP/Postal Code
54007
Country
Greece
Facility Name
Local Institution
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
H-7085
Country
Hungary
Facility Name
Local Institution
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Local Institution
City
Pecs
ZIP/Postal Code
H-7632
Country
Hungary
Facility Name
Local Institution
City
Szeged
ZIP/Postal Code
H-6720
Country
Hungary
Facility Name
Local Institution
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Local Institution
City
Wilton
State/Province
Cork
Country
Ireland
Facility Name
Local Institution
City
Dublin
ZIP/Postal Code
4
Country
Ireland
Facility Name
Local Institution
City
Dublin
ZIP/Postal Code
7
Country
Ireland
Facility Name
Local Institution
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Facility Name
Local Institution
City
Dublin
ZIP/Postal Code
9
Country
Ireland
Facility Name
Local Institution
City
Galway
Country
Ireland
Facility Name
Local Institution
City
Waterford
ZIP/Postal Code
9026
Country
Ireland
Facility Name
Local Institution
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Local Institution
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Local Institution
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Local Institution
City
Meldola (FC)
ZIP/Postal Code
47014
Country
Italy
Facility Name
Local Institution
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Local Institution
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Local Institution
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Local Institution
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Local Institution
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Local Institution
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Local Institution
City
Roma
ZIP/Postal Code
00167
Country
Italy
Facility Name
Local Institution
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Local Institution
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Local Institution
City
Torino
ZIP/Postal Code
10137
Country
Italy
Facility Name
Local Institution
City
Luxembourg
ZIP/Postal Code
1210
Country
Luxembourg
Facility Name
Local Institution
City
Amsterdam
State/Province
Noord-holland
ZIP/Postal Code
1081 HZ
Country
Netherlands
Facility Name
Local Institution
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Local Institution
City
Breda
ZIP/Postal Code
4918 EV
Country
Netherlands
Facility Name
Local Institution
City
Enschede
ZIP/Postal Code
7513 ER
Country
Netherlands
Facility Name
Local Institution
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Local Institution
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Local Institution
City
Leiden
ZIP/Postal Code
2300 RC
Country
Netherlands
Facility Name
Local Institution
City
Maastrict
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Local Institution
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Local Institution
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
Facility Name
Local Institution
City
Sittard-Geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
Facility Name
Local Institution
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Local Institution
City
Veldhoven
ZIP/Postal Code
5504 DB
Country
Netherlands
Facility Name
Local Institution
City
Zwolle
ZIP/Postal Code
8025-AB
Country
Netherlands
Facility Name
Local Institution
City
Alesund
ZIP/Postal Code
6017
Country
Norway
Facility Name
Local Institution
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Local Institution
City
Oslo
ZIP/Postal Code
0310
Country
Norway
Facility Name
Local Institution
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Local Institution
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Local Institution
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
Facility Name
Local Institution
City
Warszawa
ZIP/Postal Code
02781
Country
Poland
Facility Name
Local Institution
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Facility Name
Local Institution
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Local Institution
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Local Institution
City
Romania
ZIP/Postal Code
400015
Country
Romania
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Local Institution
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Local Institution
City
St. Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Local Institution
City
Albacete
ZIP/Postal Code
02006
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Local Institution
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
Local Institution
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Local Institution
City
Las Palmas de Gran Canaria
ZIP/Postal Code
35016
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital De Madrid, Norte Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Local Institution
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Local Institution
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Facility Name
Local Institution
City
Palma de Mallorca
ZIP/Postal Code
07010
Country
Spain
Facility Name
Local Institution
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Local Institution
City
San Sebastian
ZIP/Postal Code
20014
Country
Spain
Facility Name
Hospital Clinico Univ. de Santiago-CHUS
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Local Institution
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
Local Institution
City
Toledo
ZIP/Postal Code
45071
Country
Spain
Facility Name
Local Institution
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Local Institution
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Local Institution
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Local Institution
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Local Institution
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
Facility Name
Local Institution
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Local Institution
City
Bellinzona
ZIP/Postal Code
6501
Country
Switzerland
Facility Name
Local Institution
City
Chur
ZIP/Postal Code
7000
Country
Switzerland
Facility Name
Local Institution
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Local Institution
City
Bristol
State/Province
Avon
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Local Institution
City
Northwood
State/Province
Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Local Institution
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Local Institution
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Local Institution
City
Cottingham
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Local Institution
City
Essex
Country
United Kingdom
Facility Name
Local Institution
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Local Institution
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Local Institution
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Local Institution
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Local Institution
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
Local Institution
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Local Institution
City
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Local Institution
City
Swansea
ZIP/Postal Code
SA2 8QA
Country
United Kingdom
Facility Name
Local Institution
City
Truro
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
Local Institution
City
Wirral
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
31581055
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.
Results Reference
derived
PubMed Identifier
31445199
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.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
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)
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