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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1641

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 7, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Carcinoma, Renal Cell

Clinical Trials on nivolumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings