A Study Comparing Nivolumab, Nivolumab in Combination With Ipilimumab and Placebo in Participants With Localized Kidney Cancer Who Underwent Surgery to Remove Part of a Kidney (CheckMate 914)

November 26, 2024 updated by: Bristol-Myers Squibb

A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab vs Placebo in Participants With Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse

The purpose of this study is to determine whether nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in participants who have experienced partial or entire removal of a kidney.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study has two primary endpoints. The first primary completion date is anticipated to be reached July 2022 (DFS in Part A). The second primary completion date is anticipated to be reached July 2024 (DFS in Part B).

Study Type

Interventional

Enrollment (Actual)

1641

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1419AHN
        • Local Institution - 0179
      • Caba, Argentina, 1199
        • Local Institution - 0099
      • Cordoba, Argentina, X5004FHP
        • Local Institution - 0098
      • Cordoba, Argentina, 5000
        • Local Institution - 0096
      • San Juan, Argentina, 5402
        • Local Institution - 0164
      • Tucuman, Argentina, 4000
        • Local Institution - 0097
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, 1280
        • Local Institution - 0178
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1425
        • Local Institution - 0126
      • Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina, 1426
        • Local Institution - 0203
      • Mar Del Plata, Buenos Aires, Argentina, B7600FZO
        • Local Institution - 0208
      • Mar Del Plata, Buenos Aires, Argentina, 7600
        • Local Institution - 0095
    • Cordoba
      • Rio Cuarto, Cordoba, Argentina, 5800
        • Local Institution - 0173
    • RIO Negro
      • Bariloche, RIO Negro, Argentina
        • Local Institution - 0232
  • Australia
    • New South Wales
      • Macquarie Park, New South Wales, Australia, 2109
        • Local Institution - 0215
      • Northmead, New South Wales, Australia, 2152
        • Local Institution - 0032
      • Randwick, New South Wales, Australia, 2031
        • Local Institution - 0036
      • St Leonards, New South Wales, Australia, 2065
        • Local Institution - 0035
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Local Institution - 0113
      • Southport, Queensland, Australia, 4215
        • Local Institution - 0213
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
        • Local Institution - 0034
    • Victoria
      • Clayton, Victoria, Australia
        • Local Institution - 0033
      • Heidelberg, Victoria, Australia, 3084
        • Local Institution - 0214
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Local Institution - 0031
  • Austria
      • Linz, Austria, 4020
        • Local Institution - 0068
      • Wien, Austria, 1160
        • Local Institution - 0084
  • Belgium
      • Anderlecht, Belgium, 1070
        • Local Institution - 0064
      • Hasselt, Belgium, 3500
        • Local Institution - 0060
      • Liege, Belgium, 4000
        • Local Institution - 0059
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • Local Institution - 0058
  • Brazil
      • Rio de Janeiro, Brazil, 20775-001
        • Local Institution - 0160
      • Sao Paulo, Brazil, 01246000
        • Local Institution - 0050
    • Distrito Federal
      • Brasilia, Distrito Federal, Brazil, 70200-730
        • Local Institution - 0047
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130-090
        • Local Institution - 0045
    • RIO Grande DO SUL
      • Ijui, RIO Grande DO SUL, Brazil, 98700-000
        • Local Institution - 0046
      • Porto Alegre, RIO Grande DO SUL, Brazil, 90610-000
        • Local Institution - 0048
    • SAO Paulo
      • São Paulo, SAO Paulo, Brazil, 05652-900
        • Local Institution - 0044
    • Sao Paulo
      • Barretos, Sao Paulo, Brazil, 14780-070
        • Local Institution - 0043
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Local Institution - 0041
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 3L6
        • Local Institution - 0086
    • Ontario
      • Oshawa, Ontario, Canada, L1G 2B9
        • Local Institution - 0087
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution - 0112
    • Quebec
      • Montreal, Quebec, Canada, H2X 0C1
        • Local Institution - 0042
      • Rimouski, Quebec, Canada, G5L 5T1
        • Local Institution - 0040
  • Chile
    • Coquimbo
      • La Serena, Coquimbo, Chile, 1720430
        • Local Institution - 0223
    • Metropolitana
      • Santiago, Metropolitana, Chile, 7500713
        • Local Institution
      • Santiago, Metropolitana, Chile, 8420383
        • Local Institution - 0221
      • Santiago, Metropolitana, Chile
        • Local Institution - 0246
    • Valparaiso
      • Vina del Mar, Valparaiso, Chile, 2520598
        • Local Institution - 0222
  • China
      • Guangzhou, China
        • Local Institution - 0134
      • Nanjing, China, 210008
        • Local Institution - 0139
      • Shanghai, China, 200032
        • Local Institution - 0176
    • Beijing
      • Beijing, Beijing, China, 100032
        • Local Institution - 0147
      • Beijing, Beijing, China, 100034
        • Local Institution - 0153
      • Beijing, Beijing, China, 100853
        • Local Institution - 0159
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Local Institution - 0132
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Local Institution - 0141
    • Hebei
      • Wuhan, Hebei, China, 430030
        • Local Institution - 0194
    • Hubei
      • Wuhan, Hubei, China, 430061
        • Local Institution - 0133
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Local Institution - 0138
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Local Institution - 0140
    • Jilin
      • Changchun, Jilin, China, 130021
        • Local Institution - 0145
    • Shan3xi
      • Xi'an, Shan3xi, China, 710061
        • Local Institution - 0144
    • Shandong
      • Yantai, Shandong, China, 264000
        • Local Institution - 0146
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Local Institution - 0137
      • Shanghai, Shanghai, China, 200032
        • Local Institution - 0166
      • Shanghai, Shanghai, China, 200433
        • Local Institution - 0148
      • Shanghai, Shanghai, China, 200040
        • Local Institution - 0152
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Local Institution - 0143
      • Chengdu, Sichuan, China, 610041
        • Local Institution - 0142
    • Tianjin
      • Tianjin, Tianjin, China, 300222
        • Local Institution - 0175
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Local Institution - 0157
      • Hangzhou, Zhejiang, China, 310014
        • Local Institution - 0131
  • Colombia
      • Bogotá, Colombia, 111511
        • Local Institution - 0229
      • Floridablanca, Colombia
        • Local Institution - 0230
      • Pereira, Colombia, 99999
        • Local Institution - 0226
    • Antioquia
      • Medellin, Antioquia, Colombia, 050034
        • Local Institution - 0227
    • Cesar
      • Valledupar, Cesar, Colombia, 200001
        • Local Institution - 0228
  • Czechia
      • Hradec Kralove, Czechia, 500 05
        • Local Institution - 0094
      • Olomouc, Czechia, 779 00
        • Local Institution - 0025
  • France
      • Besançon Cedex, France, 25030
        • Local Institution - 0083
      • Bordeaux, France, 33000
        • Local Institution - 0080
      • La Roche-Sur-Yon Cedex 9, France, 85925
        • Local Institution - 0082
      • Lyon Cedex 08, France, 69373
        • Local Institution - 0116
      • Marseille Cedex 9, France, 13273
        • Local Institution - 0079
      • Paris, France, 75015
        • Local Institution - 0198
      • Rennes, France, 35042
        • Local Institution - 0081
      • Strasbourg, France, 67200
        • Local Institution - 0077
      • Toulouse Cedex 9, France, 31059
        • Local Institution - 0115
      • Tours Cedex, France, 37044
        • Local Institution - 0150
      • Vandoeuvre Les Nancy, France, 54511
        • Local Institution - 0078
      • Villejuif, France, 94800
        • Local Institution - 0076
  • Germany
      • Aachen, Germany, 52074
        • Local Institution - 0053
      • Essen, Germany, 45147
        • Local Institution - 0103
      • Hamburg, Germany, 22763
        • Local Institution - 0052
      • Hannover, Germany, 30625
        • Local Institution - 0061
      • Hannover, Germany, 30559
        • Local Institution - 0231
      • Jena, Germany, 07747
        • Local Institution - 0062
      • Munich, Germany, 81377
        • Local Institution - 0102
      • Nuernberg, Germany, 90419
        • Local Institution - 0054
      • Rostock, Germany, 18057
        • Local Institution - 0055
      • Wuerzburg, Germany, 97080
        • Local Institution - 0101
    • Baden-Württemberg
      • Tubingen, Baden-Württemberg, Germany, 72076
        • Local Institution - 0217
  • Italy
      • Arezzo, Italy, 52100
        • Local Institution - 0105
      • Cremona, Italy, 26100
        • Local Institution - 0172
      • Napoli, Italy, 80131
        • Local Institution - 0106
      • Parma, Italy, 43100
        • Local Institution - 0107
      • Roma, Italy, 00168
        • Local Institution - 0109
      • Verona, Italy, 37134
        • Local Institution - 0108
  • Japan
      • Hiroshima, Japan, 734-8551
        • Local Institution - 0165
      • Wakayama, Japan, 641-8510
        • Local Institution - 0192
      • Yamagata, Japan, 990-9585
        • Local Institution - 0127
    • Aichi
      • Toyoake Shi, Aichi, Japan, 4701192
        • Local Institution - 0129
    • Aomori
      • Hirosaki-shi, Aomori, Japan, 0368563
        • Local Institution - 0193
    • Chiba
      • Chiba-shi, Chiba, Japan, 260-8717
        • Local Institution - 0158
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 8128582
        • Local Institution - 0121
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan, 0608648
        • Local Institution - 0156
    • Hyogo
      • Kobe-shi, Hyogo, Japan, 6500017
        • Local Institution - 0167
    • Ibaraki
      • Tsukuba-shi, Ibaraki, Japan, 3058576
        • Local Institution - 0191
    • Iwate
      • Shiwa-gun, Iwate, Japan, 0283695
        • Local Institution - 0168
    • Kanagawa
      • Yokohama-shi, Kanagawa, Japan, 2360004
        • Local Institution - 0128
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japan, 860-0811
        • Local Institution - 0216
    • Kyoto
      • Kamigyo-ku, Kyoto, Japan, 602-8566
        • Local Institution - 0130
    • Nagasaki
      • Nagasaki-shi, Nagasaki, Japan, 8528102
        • Local Institution - 0123
    • Niigata
      • Niigata-shi, Niigata, Japan, 9518520
        • Local Institution - 0120
    • Osaka
      • Osakasayama-shi, Osaka, Japan, 5898511
        • Local Institution - 0125
      • Suita-shi, Osaka, Japan, 565-0871
        • Local Institution - 0122
    • Tokushima
      • Tokushima-shi, Tokushima, Japan, 770-8503
        • Local Institution - 0162
    • Tokyo
      • Adachi-ku, Tokyo, Japan, 1230872
        • Local Institution - 0188
      • Bunkyo-ku, Tokyo, Japan, 113-8510
        • Local Institution - 0189
      • Bunkyo-ku, Tokyo, Japan, 1138603
        • Local Institution - 0119
      • Shinjuku-ku, Tokyo, Japan, 1608582
        • Local Institution - 0149
    • Yamaguchi
      • Ube-shi, Yamaguchi, Japan, 7558505
        • Local Institution - 0163
  • Mexico
      • Chihuahua, Mexico, 31000
        • Local Institution - 0089
      • Monterrey, NL, Mexico, 64060
        • Local Institution - 0088
      • San Luis Potosi, Mexico, 78250
        • Local Institution - 0169
    • BAJA California
      • Tijuana, BAJA California, Mexico, 22010
        • Local Institution - 0242
    • Chiapas
      • Tuxtla Gutierrez, Chiapas, Mexico, 29090
        • Local Institution - 0197
    • Coahuila
      • Torreón, Coahuila, Mexico, 27010
        • Local Institution - 0195
    • Distrito Federal
      • Ciudad de Mexico, Distrito Federal, Mexico, 03100
        • Local Institution - 0151
      • Tlalpan, Distrito Federal, Mexico, 14080
        • Local Institution - 0111
    • Jalisco
      • Zapopan, Jalisco, Mexico, 45030
        • Local Institution - 0110
    • Sinaloa
      • Mazatlan, Sinaloa, Mexico, 82110
        • Local Institution - 0104
    • Yucatan
      • Merida, Yucatan, Mexico, 97070
        • Local Institution - 0196
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Local Institution - 0066
      • Rotterdam, Netherlands, 3008 AE
        • Local Institution - 0067
      • Zwolle, Netherlands, 8025 AB
        • Local Institution - 0092
  • Poland
      • Bydgoszcz, Poland, 85-796
        • Local Institution - 0155
      • Wroclaw, Poland, 53-413
        • Local Institution - 0038
  • Romania
      • Bucharest, Romania, 022328
        • Local Institution - 0243
      • Cluj, Romania, 400015
        • Local Institution - 0247
      • Cluj-Napoca, Romania, 400015
        • Local Institution - 0200
      • Craiova, Romania, 200542
        • Local Institution - 0199
      • Iași, Romania, 700483
        • Local Institution - 0202
  • Russian Federation
      • Moscow, Russian Federation, 117997
        • Local Institution - 0065
      • Novosibirsk, Russian Federation, 630099
        • Local Institution - 0170
      • Saint-Petersburg, Russian Federation, 194044
        • Local Institution - 0171
      • Saint-Petersburg, Russian Federation, 198255
        • Local Institution - 0021
  • Singapore
      • Singapore, Singapore, 119074
        • Local Institution - 0017
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 168583
        • Local Institution - 0018
  • Spain
      • Barcelona, Spain, 08035
        • Local Institution - 0204
      • Barcelona, Spain, 08036
        • Local Institution - 0206
      • Caceres, Spain, 10003
        • Local Institution - 0124
      • Cordoba, Spain, 14004
        • Local Institution - 0207
      • Lugo, Spain, 27003
        • Local Institution - 0118
      • Madrid, Spain, 28034
        • Local Institution - 0114
      • Madrid, Spain, 28041
        • Local Institution - 0205
      • Sabadell, Spain, 08208
        • Local Institution - 0117
      • Sevilla, Spain, 41013
        • Local Institution - 0161
  • Switzerland
      • Chur, Switzerland, 7000
        • Local Institution - 0218
      • Sankt Gallen, Switzerland, 9007
        • Local Institution - 0219
      • Zuerich, Switzerland, 8091
        • Local Institution - 0225
  • Turkey
      • Ankara, Turkey, 06590
        • Local Institution - 0209
      • Istanbul, Turkey, 34098
        • Local Institution - 0210
      • Istanbul, Turkey, 34214
        • Local Institution
  • United Kingdom
      • Manchester, United Kingdom, M20 4BX
        • Local Institution - 0063
      • Northwood, United Kingdom, HA6 2RN
        • Local Institution - 0071
      • Preston, United Kingdom, PR2 9HT
        • Local Institution - 0073
      • Swansea, United Kingdom, SA2 8QA
        • Local Institution - 0072
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Local Institution - 0075
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Local Institution - 0019
    • Arkansas
      • Springdale, Arkansas, United States, 72762
        • Local Institution - 0056
    • California
      • Los Angeles, California, United States, 90048
        • Local Institution - 0186
      • Los Angeles, California, United States, 90095
        • Local Institution - 0180
      • San Francisco, California, United States, 94115
        • Local Institution - 0002
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Local Institution - 0185
    • Georgia
      • Athens, Georgia, United States, 30607
        • Local Institution - 0016
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Local Institution - 0005
      • Chicago, Illinois, United States, 60612
        • Local Institution
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Local Institution - 0006
    • New Jersey
      • Howell, New Jersey, United States, 07731
        • Local Institution - 0012
    • New York
      • Buffalo, New York, United States, 14263
        • Local Institution - 0007
      • New York, New York, United States, 10065
        • Local Institution - 0001
      • New York, New York, United States, 10029
        • Local Institution - 0181
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Local Institution - 0008
    • Oregon
      • Portland, Oregon, United States, 97213
        • Local Institution - 0009
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Local Institution - 0010
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Local Institution - 0014
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Local Institution - 0013
      • Nashville, Tennessee, United States, 37212
        • Local Institution - 0183
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Local Institution - 0057

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Kidney tumor has been completely resected with negative surgical margins obtained. The randomization must occur greater than 4 weeks and less than (or equal to) 12 weeks from the date of nephrectomy
  • Pathologic tumor, node, and metastasis (TNM) staging meeting one of the following: pT2a, G3 or G4, N0 M0; pT2b, G any, N0 M0; pT3, (a, b, c), G any, N0 M0; pT4, G any, N0 M0; pT any, G any, N1 M0
  • Post-nephrectomy tumor shows renal cell cancer (RCC) with a predominantly clear cell histology, including participants with sarcomatoid features
  • Participants must have no clinical or radiological evidence of macroscopic residual disease or distant metastases after nephrectomy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
  • Women must agree to follow methods of contraception, if applicable

Exclusion Criteria:

  • Participants with an active known or suspected autoimmune disease
  • Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
  • Any severe or serious, acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation
  • History of allergy or hypersensitivity to study drug components
  • Participants with a condition requiring systemic treatment with corticosteroids
  • Participants who have received a live/attenuated vaccine within 30 days of first treatment

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A, Arm A: nivolumab + ipilimumab
Biological: nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
Biological: ipilimumab
Specified dose on specified days
Other Names:
  • Yervoy
Placebo Comparator: Part A, Arm B: nivolumab placebo + ipilimumab placebo
Drug: nivolumab placebo
Specified dose on specified days
Drug: ipilimumab placebo
Specified dose on specified days
Experimental: Part B, Arm A: nivolumab + ipilimumab
Biological: nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
Biological: ipilimumab
Specified dose on specified days
Other Names:
  • Yervoy
Placebo Comparator: Part B, Arm B: nivolumab placebo + ipilimumab placebo
Drug: nivolumab placebo
Specified dose on specified days
Drug: ipilimumab placebo
Specified dose on specified days
Experimental: Part B, Arm C: nivolumab + ipilimumab placebo
Biological: nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
Drug: ipilimumab placebo
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-Free Survival (DFS) by BICR - Treatment Part A and B
Time Frame: From randomization to development of local disease recurrence, distance metastasis, or death, whichever came first (up to approximately 72 months)
Disease-Free Survival (DFS) is defined as the time from randomization to development of local disease recurrence (ie, recurrence of primary tumor in situ or occurrence of a secondary renal cell carcinoma (RCC) primary cancer), distance metastasis, or death, whichever came first per Blinded Independent Central Review (BICR) based on Kaplan-Meier estimates.
From randomization to development of local disease recurrence, distance metastasis, or death, whichever came first (up to approximately 72 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) - Treatment Part A and B
Time Frame: From randomization to the date of death (up to approximately 72 months)
Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS will be censored on the last date the participants was known to be alive. Based on Kaplan-Meier estimates.
From randomization to the date of death (up to approximately 72 months)
Overall Survival (OS) Rate (5 Years) - Treatment Part A and B
Time Frame: At 5 years
Overall survival rate at 5 years is defined as the percentage of participants who are alive at 5 years.
At 5 years
Disease-Free Survival (DFS) Per BICR in Contemporaneously Randomized Combination and Monotherapy Participants - Treatment Part B
Time Frame: From randomization to development of local disease recurrence, distance metastasis, or death, whichever came first (up to approximately 72 months)
Disease-Free Survival (DFS) is defined as the time from randomization to development of local disease recurrence (ie, recurrence of primary tumor in situ or occurrence of a secondary renal cell carcinoma (RCC) primary cancer), distance metastasis, or death, whichever came first per Blinded Independent Central Review (BICR) based on Kaplan-Meier estimates.
From randomization to development of local disease recurrence, distance metastasis, or death, whichever came first (up to approximately 72 months)
Overall Survival (OS) in the Contemporaneously Randomized Combination and Monotherapy Participants - Treatment Part B
Time Frame: From randomization to the date of death (up to approximately 72 months)
Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS will be censored on the last date the participants was known to be alive. Based on Kaplan-Meier estimates
From randomization to the date of death (up to approximately 72 months)
The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part A
Time Frame: From first dose to 30 days post last dose (up to approximately 40 weeks)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Graded according to NCI CTCAE (Version 4) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.
From first dose to 30 days post last dose (up to approximately 40 weeks)
The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part B
Time Frame: From first dose to 30 days post last dose (up to approximately 40 weeks)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Graded according to NCI CTCAE (Version 4) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.
From first dose to 30 days post last dose (up to approximately 40 weeks)
The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part A
Time Frame: From first dose to 100 days post last dose (up to approximately 50 weeks)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Graded according to NCI CTCAE (Version 4) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.
From first dose to 100 days post last dose (up to approximately 50 weeks)
The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part B
Time Frame: From first dose to 100 days post last dose (up to approximately 50 weeks)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Graded according to NCI CTCAE (Version 4) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.
From first dose to 100 days post last dose (up to approximately 50 weeks)
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A
Time Frame: From first dose to 30 days post last dose (up to approximately 40 weeks)
Graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE, Version 4.0] where grade 3 = severe, and grade 4 = life-threatening. Baseline evaluations are defined as evaluations or events that occur before the date and time of the first dose of study treatment.
From first dose to 30 days post last dose (up to approximately 40 weeks)
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B
Time Frame: From first dose to 30 days post last dose (up to approximately 40 weeks)
Graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE, Version 4.0] where grade 3 = severe, and grade 4 = life-threatening. Baseline evaluations are defined as evaluations or events that occur before the date and time of the first dose of study treatment.
From first dose to 30 days post last dose (up to approximately 40 weeks)
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A
Time Frame: From first dose to 100 days post last dose (up to approximately 50 weeks)
Graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE, Version 4.0] where grade 3 = severe, and grade 4 = life-threatening. Baseline evaluations are defined as evaluations or events that occur before the date and time of the first dose of study treatment.
From first dose to 100 days post last dose (up to approximately 50 weeks)
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B
Time Frame: From first dose to 100 days post last dose (up to approximately 50 weeks)
Graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE, Version 4.0] where grade 3 = severe, and grade 4 = life-threatening. Baseline evaluations are defined as evaluations or events that occur before the date and time of the first dose of study treatment.
From first dose to 100 days post last dose (up to approximately 50 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2017

Primary Completion (Actual)

September 28, 2023

Study Completion (Actual)

February 1, 2024

Study Registration Dates

First Submitted

May 1, 2017

First Submitted That Met QC Criteria

May 1, 2017

First Posted (Actual)

May 3, 2017

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

November 26, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-914
  • 2016-004502-34 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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