Melanoma Clinical Trial

Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)

Summary

The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with Ipilimumab will extend progression free survival and overall survival compared to Ipilimumab alone.

View Eligibility Criteria

Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Histologically confirmed stage III (unresectable) or stage IV melanoma
Treatment naïve patients
Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria
Tumor tissue from an unresectable or metastatic site of disease for biomarker analyses
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Exclusion Criteria:

Active brain metastases or leptomeningeal metastases
Ocular melanoma
Subjects with active, known or suspected autoimmune disease
Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment
Prior treatment with an anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD-L2, or anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA-4) antibody

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

1296

Study ID:

NCT01844505

Recruitment Status:

Active, not recruiting

Sponsor:

Bristol-Myers Squibb

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There are 142 Locations for this study

See Locations Near You

Local Institution - 0085
Gilbert Arizona, 85234, United States
University of Arizona Cancer Center
Tucson Arizona, 85724, United States
Local Institution - 0046
La Jolla California, 92093, United States
Local Institution - 0053
Los Angeles California, 90025, United States
Local Institution - 0014
Los Angeles California, 90095, United States
Comprehensive Cancer Center At Desert Regional Medical Ctr
Palm Springs California, 92262, United States
Local Institution - 0066
Rancho Mirage California, 92270, United States
California Pacific Medical Center Research Institute
San Francisco California, 94115, United States
Local Institution - 0049
San Francisco California, 94143, United States
Local Institution - 0052
Aurora Colorado, 80045, United States
Local Institution - 0084
New Haven Connecticut, 06520, United States
Local Institution - 0098
Washington District of Columbia, 20007, United States
Local Institution - 0183
Washington District of Columbia, 20010, United States
Local Institution - 0042
Jacksonville Florida, 32207, United States
Local Institution - 0008
Orlando Florida, 32806, United States
Local Institution - 0051
Atlanta Georgia, 30322, United States
Maine Center For Cancer Medicine
Scarborough Maine, 04074, United States
Local Institution - 0080
Lutherville Maryland, 21093, United States
Local Institution - 0081
Boston Massachusetts, 02215, United States
Local Institution - 0082
Boston Massachusetts, 02215, United States
Local Institution - 0083
Boston Massachusetts, 02215, United States
Local Institution - 0087
Ann Arbor Michigan, 48109, United States
Local Institution - 0187
Minneapolis Minnesota, 55407, United States
Local Institution - 0065
Jackson Mississippi, 39216, United States
Local Institution - 0067
Saint Louis Missouri, 63110, United States
Local Institution - 0015
Las Vegas Nevada, 89148, United States
Local Institution - 0188
Morristown New Jersey, 07962, United States
Local Institution - 0068
Albuquerque New Mexico, 87106, United States
Local Institution - 0079
Albany New York, 12206, United States
Local Institution - 0174
New York New York, 10016, United States
Local Institution - 0070
New York New York, 10020, United States
Local Institution - 0047
Charlotte North Carolina, 28204, United States
Local Institution - 0048
Durham North Carolina, 27710, United States
Local Institution - 0007
Cleveland Ohio, 44106, United States
Local Institution - 0045
Portland Oregon, 97213, United States
Local Institution - 0061
Allentown Pennsylvania, 18102, United States
Local Institution - 0112
Bethlehem Pennsylvania, 18015, United States
Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States
Local Institution - 0154
Greenville South Carolina, 29605, United States
Local Institution - 0062
Nashville Tennessee, 37203, United States
Local Institution - 0064
Nashville Tennessee, 37232, United States
Local Institution - 0044
Dallas Texas, 75246, United States
Texas Oncology
Dallas Texas, 75246, United States
Local Institution - 0088
Houston Texas, 77030, United States
Local Institution - 0089
Salt Lake City Utah, 84112, United States
Local Institution - 0054
Seattle Washington, 98109, United States
Local Institution - 0017
Camperdown New South Wales, 2050, Australia
Local Institution - 0031
Coffs Harbour New South Wales, 2450, Australia
Local Institution - 0028
Gateshead New South Wales, 2290, Australia
Local Institution - 0023
Macquarie University New South Wales, 2109, Australia
Local Institution - 0138
North Sydney New South Wales, 2060, Australia
Local Institution - 0019
Brisbane Queensland, 4120, Australia
Local Institution - 0022
Southport Queensland, 4215, Australia
Local Institution - 0018
Woolloongabba Queensland, 4102, Australia
Local Institution - 0020
Adelaide South Australia, 5000, Australia
Local Institution - 0025
Kurralta Park South Australia, 5037, Australia
Local Institution - 0024
Box Hill Victoria, 3128, Australia
Local Institution - 0016
Heidelberg Victoria, 3084, Australia
Local Institution - 0026
Melbourne Victoria, 3000, Australia
Local Institution - 0021
Nedlands Western Australia, 6009, Australia
Local Institution - 0148
Salzburg , 5020, Austria
Local Institution - 0145
Wien , 1090, Austria
Local Institution - 0003
Brussels , 1090, Belgium
Local Institution - 0002
Bruxelles , 1200, Belgium
Local Institution - 0004
Edegem , 2650, Belgium
Local Institution - 0005
Gent , 9000, Belgium
Local Institution - 0103
Leuven , 3000, Belgium
Local Institution - 0140
Edmonton Alberta, T6G 1, Canada
Local Institution - 0165
Vancouver British Columbia, V5Z 4, Canada
Local Institution - 0141
London Ontario, N6A 4, Canada
Local Institution - 0143
Ottawa Ontario, K1H 8, Canada
Local Institution - 0166
Toronto Ontario, M5G 2, Canada
Local Institution - 0139
Montreal Quebec, H2X 3, Canada
Local Institution - 0142
Quebec City Quebec, G1J 1, Canada
Local Institution - 0092
Brno , 656 5, Czechia
Local Institution - 0091
Hradec Kralove , 500 0, Czechia
Local Institution - 0090
Praha 2 , 128 0, Czechia
Local Institution - 0167
Praha 8 , 180 8, Czechia
Local Institution - 0076
Aarhus , 8200, Denmark
Local Institution - 0078
Herlev , 2730, Denmark
Local Institution - 0077
Odense , 5000, Denmark
Local Institution - 0071
Helsinki Uusimaa, 00290, Finland
Local Institution - 0169
Tampere , 33521, Finland
Local Institution - 0125
Boulogne Billancourt , 92104, France
Local Institution - 0126
Marseille Cedex 5 , 13385, France
Local Institution - 0056
Nantes Cedex , 44093, France
Local Institution - 0058
Paris Cedex 10 , 75475, France
Local Institution - 0124
Pierre Benite , 69310, France
Local Institution - 0127
Rennes , 35042, France
Local Institution
Villejuif , 94805, France
Local Institution - 0162
Buxtehude , 21614, Germany
Local Institution - 0161
Erfurt , 99089, Germany
Local Institution - 0171
Erlangen , 91054, Germany
Local Institution - 0156
Essen , 45147, Germany
Local Institution - 0159
Hannover , 30625, Germany
Local Institution - 0157
Heidelberg , 69120, Germany
Local Institution - 0158
Kiel , 24105, Germany
Local Institution - 0178
Leipzig , 04103, Germany
Local Institution - 0160
Munchen , 80337, Germany
Local Institution - 0134
Tuebingen , 72076, Germany
Local Institution - 0035
Dublin 9 Dublin, , Ireland
Local Institution - 0033
Cork , T12DF, Ireland
Local Institution - 0168
Dublin , 01, Ireland
Local Institution - 0036
Dublin , 7, Ireland
Local Institution - 0034
Dublin , , Ireland
Local Institution - 0032
Galway , 0, Ireland
Local Institution - 0120
Jerusalem , 91120, Israel
Local Institution - 0121
Tel Hashomer , 52621, Israel
Local Institution - 0176
Bergamo , 24127, Italy
Local Institution - 0115
Genova , 16132, Italy
Local Institution - 0113
Meldola (FC) , 47014, Italy
Local Institution - 0172
Milano , 20133, Italy
Local Institution - 0117
Milano , 20141, Italy
Local Institution - 0114
Napoli , 80131, Italy
Local Institution - 0118
Padova , 35128, Italy
Local Institution - 0177
Roma , 00144, Italy
Local Institution - 0116
Siena , 53100, Italy
Local Institution - 0010
Amsterdam , 1066 , Netherlands
Local Institution - 0012
Leiden , 2333 , Netherlands
Local Institution - 0013
Nijmegen , 6525 , Netherlands
Local Institution - 0029
Auckland , 1142, New Zealand
Local Institution - 0123
Oslo , 0424, Norway
Local Institution - 0109
Gdansk , 80-95, Poland
Local Institution - 0133
Krakow , 31-11, Poland
Local Institution - 0060
Lodz , 93-51, Poland
Local Institution - 0059
Warszawa , 02-78, Poland
Local Institution - 0130
Moscow , 11547, Russian Federation
Local Institution - 0132
Saint Petersburg , 19775, Russian Federation
Local Institution - 0131
Samara , 44303, Russian Federation
Local Institution - 0128
St. Petersburg , 19825, Russian Federation
Local Institution - 0152
Badalona-Barcelona , 08916, Spain
Local Institution - 0151
Barcelona , 08035, Spain
Local Institution - 0175
Barcelona , 08036, Spain
Local Institution - 0150
Madrid , 28007, Spain
Local Institution - 0149
Madrid , 28046, Spain
Local Institution - 0153
Malaga , 29010, Spain
Local Institution - 0147
Pamplona , 31008, Spain
Local Institution - 0182
Gothenberg , 413 4, Sweden
Local Institution - 0184
Stockholm , 171 7, Sweden
Local Institution - 0164
Geneva , 1211, Switzerland
Local Institution - 0189
Lausanne , 1011, Switzerland
Local Institution - 0186
St. Gallen , 9007, Switzerland
Local Institution - 0163
Zuerich , 8091, Switzerland
Local Institution - 0039
Glasgow Dumfries & Galloway, G12 0, United Kingdom
Local Institution - 0038
London Greater London, SW3 6, United Kingdom
Local Institution - 0119
Manchester Greater Manchester, M20 4, United Kingdom
Local Institution - 0041
Northwood Middlesex, HA6 2, United Kingdom
Local Institution - 0122
Nottingham Nottinghamshire, NG5 1, United Kingdom
Local Institution - 0037
Cambridge , CB2 2, United Kingdom
Local Institution - 0040
Swansea , SA2 8, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

1296

Study ID:

NCT01844505

Recruitment Status:

Active, not recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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