A Study to Evaluate Efficacy in Subjects With Esophageal Cancer Treated With Nivolumab and Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin (CheckMate 648)

February 13, 2026 updated by: Bristol-Myers Squibb

A Randomized Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin in Subjects With Unresectable Advanced, Recurrent or Metastatic Previously Untreated Esophageal Squamous Cell Carcinoma

The main purpose of this study is to compare how long subjects with esophageal cancer live overall or live without disease progression after receiving nivolumab and ipilimumab or nivolumab combined with fluorouracil plus cisplatin versus fluorouracil plus cisplatin

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.

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.
970

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

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
No longer available

No longer available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

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
      • Buenos Aires, Buenos Aires, Argentina, 1417
        • Local Institution - 0048
      • Capital Federal, Buenos Aires, Argentina, 1264
        • Local Institution - 0050
    • La Rioja Province
      • La Rioja, La Rioja Province, Argentina, 5300
        • Local Institution - 0087
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Local Institution - 0086
  • Australia
    • New South Wales
      • Tamworth, New South Wales, Australia, 2340
        • Local Institution - 0232
    • Queensland
      • Douglas, Queensland, Australia, 4814
        • Local Institution - 0011
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Local Institution - 0010
  • Austria
      • Salzburg, Austria, 5020
        • Local Institution - 0241
  • Brazil
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 41950-640
        • Local Institution - 0017
    • Minas Gerais
      • Ipatinga, Minas Gerais, Brazil, 35160-158
        • Local Institution - 0227
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brazil, 98700-000
        • Local Institution - 0021
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
        • Local Institution - 0016
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brazil, 22793-080
        • Local Institution - 0228
    • São Paulo
      • Barretos, São Paulo, Brazil, 14780-070
        • Local Institution - 0019
      • Jaú, São Paulo, Brazil, 17210-080
        • Local Institution - 0226
      • São José do Rio Preto, São Paulo, Brazil, 15090000
        • Local Institution - 0018
      • São Paulo, São Paulo, Brazil, 01246-000
        • Local Institution - 0020
  • Canada
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • Local Institution - 0095
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Local Institution - 0082
      • Montreal, Quebec, Canada, H4A 3J1
        • Local Institution - 0222
      • Trois-Rivières, Quebec, Canada, G8Z 3R9
        • Local Institution - 0037
  • Chile
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 8320000
        • Local Institution - 0053
      • Santiago, Santiago Metropolitan, Chile
        • Local Institution - 0214
  • China
      • Shenyang, China, 110042
        • Local Institution - 0220
      • Xi'an, China
        • Local Institution - 0248
    • Anhui
      • Hefei, Anhui, China, 230022
        • Local Institution - 0207
      • Hefei, Anhui, China, 230061
        • Local Institution - 0197
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100032
        • Local Institution - 0182
      • Beijing, Beijing Municipality, China, 100071
        • Local Institution - 0179
      • Beijing, Beijing Municipality, China, 100853
        • Local Institution - 0216
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Local Institution - 0217
      • Fuzhou, Fujian, China, 350025
        • Local Institution - 0219
    • Guangdong
      • Shantou, Guangdong, China, 515041
        • Local Institution - 0199
    • Heilongjiang
      • Harbin, Heilongjiang, China, 155040
        • Local Institution - 0185
    • Henan
      • Zhengzhou, Henan, China
        • Local Institution - 0193
      • Zhengzhou, Henan, China, 450008
        • Local Institution - 0195
      • Zhengzhou, Henan, China, 450052
        • Local Institution - 0194
    • Hunan
      • Changsha, Hunan, China, 410000
        • Local Institution - 0249
      • Changsha, Hunan, China, 410008
        • Local Institution - 0212
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Local Institution - 0201
    • Jilin
      • Changchun, Jilin, China, 130021
        • Local Institution - 0180
    • Shan3xi
      • Xi'an, Shan3xi, China, 710038
        • Local Institution - 0183
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200030
        • Local Institution - 0215
      • Shanghai, Shanghai Municipality, China, 200032
        • Local Institution - 0200
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Local Institution - 0184
      • Linhai, Zhejiang, China, 317000
        • Local Institution - 0247
  • Colombia
      • Medellín, Colombia, 050034
        • Local Institution - 0058
      • Montería, Colombia, 230001
        • Local Institution - 0224
      • Pereira, Colombia, 660004
        • Local Institution - 0094
    • Bogota D.C.
      • Bogotá, Bogota D.C., Colombia
        • Local Institution - 0059
  • Czechia
      • Brno, Czechia, 625 00
        • Local Institution - 0083
      • Brno, Czechia, 656 53
        • Local Institution - 0008
      • Nový Jičín, Czechia, 741 01
        • Local Institution - 0006
  • Denmark
      • Odense, Denmark, 5000
        • Local Institution - 0099
  • France
      • Caen, France, 14076
        • Local Institution - 0114
      • Montpellier, France, 34090
        • Local Institution - 0112
      • Rennes, France, 35042
        • Local Institution - 0113
      • Toulouse, France, 31059
        • Local Institution - 0242
      • Villejuif, France, 94800
        • Local Institution - 0115
    • Nord
      • Lille, Nord, France, 59000
        • Local Institution - 0116
  • Hong Kong
      • Hong Kong, Hong Kong
        • Local Institution - 0035
      • Kowloon, Hong Kong
        • Local Institution - 0070
  • Italy
      • Bergamo, Italy, 24127
        • Local Institution - 0085
      • Milan, Italy, 20133
        • Local Institution - 0039
      • Padua, Italy, Padova
        • Local Institution - 0084
      • Pisa, Italy, 56126
        • Local Institution - 0240
  • Japan
    • Akita
      • Akita, Akita, Japan, 010-8543
        • Local Institution - 0152
    • Aomori
      • Hirosaki-shi, Aomori, Japan, 0368563
        • Local Institution - 0104
    • Chiba
      • Chiba, Chiba, Japan, 260-8717
        • Local Institution - 0101
      • Chiba, Chiba, Japan, 2608670
        • Local Institution - 0153
      • Kashiwa-shi, Chiba, Japan, 2778577
        • Local Institution - 0173
    • Ehime
      • Matsuyama, Ehime, Japan, 7900024
        • Local Institution - 0169
      • Matsuyama, Ehime, Japan, 7910280
        • Local Institution - 0119
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 8111395
        • Local Institution - 0174
      • Fukuoka, Fukuoka, Japan, 8128582
        • Local Institution - 0142
    • Fukushima
      • Fukushima, Fukushima, Japan, 9601295
        • Local Institution - 0103
    • Gifu
      • Gifu, Gifu, Japan, 5011194
        • Local Institution - 0154
    • Gunma
      • Ōta, Gunma, Japan, 3738550
        • Local Institution - 0176
    • Hiroshima
      • Hiroshima, Hiroshima, Japan, 7348551
        • Local Institution - 0100
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Local Institution - 0111
    • Hyōgo
      • Akashi-shi, Hyōgo, Japan, 6738558
        • Local Institution - 0170
      • Kobe, Hyōgo, Japan, 6500017
        • Local Institution - 0172
      • Kobe, Hyōgo, Japan, 6500047
        • Local Institution - 0118
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8530
        • Local Institution - 0171
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Japan, 8908520
        • Local Institution - 0229
    • Kanagawa
      • Isehara, Kanagawa, Japan, 259-1193
        • Local Institution - 0127
      • Kawasaki-shi, Kanagawa, Japan, 216-8511
        • Local Institution - 0109
      • Sagamihara-shi, Kanagawa, Japan, 2520375
        • Local Institution - 0105
      • Yokohama, Kanagawa, Japan, 2360004
        • Local Institution - 0147
      • Yokohama, Kanagawa, Japan, 2418515
        • Local Institution - 0117
    • Kumamoto
      • Kumamoto, Kumamoto, Japan, 8608556
        • Local Institution - 0141
    • Kyoto
      • Kamigyō-ku, Kyoto, Japan, 602-8566
        • Local Institution - 0120
      • Kyoto, Kyoto, Japan, 606-8507
        • Local Institution - 0145
    • Miyagi
      • Sendai, Miyagi, Japan, 9808575
        • Local Institution - 0144
    • Niigata
      • Niigata, Niigata, Japan, 9518566
        • Local Institution - 0146
    • Okayama-ken
      • Kurashiki-shi, Okayama-ken, Japan, 7010192
        • Local Institution - 0135
      • Okayama, Okayama-ken, Japan, 7008558
        • Local Institution - 0137
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Local Institution - 0221
      • Osaka, Osaka, Japan, 5418567
        • Local Institution - 0138
      • Sayama, Osaka, Japan, 589-8511
        • Local Institution - 0098
      • Suita, Osaka, Japan, 5650871
        • Local Institution - 0107
      • Takatsuki, Osaka, Japan, 569-8686
        • Local Institution - 0139
    • Saitama
      • Hidaka-shi, Saitama, Japan, 3501298
        • Local Institution - 0230
      • Kitaadachi-gun, Saitama, Japan, 3620806
        • Local Institution - 0175
    • Shizuoka
      • Shizuoka, Shizuoka, Japan, 4208527
        • Local Institution - 0108
      • Sunto-gun, Shizuoka, Japan, 411-8777
        • Local Institution - 0143
    • Tochigi
      • Shimotsuga-gun, Tochigi, Japan, 321-0293
        • Local Institution - 0148
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 1138677
        • Local Institution - 0110
      • Bunkyo-ku, Tokyo, Japan, 1138519
        • Local Institution - 0106
      • Chuo-ku, Tokyo, Japan, 1040045
        • Local Institution - 0136
      • Chuo-ku, Tokyo, Japan, 1048560
        • Local Institution - 0128
      • Koto-ku, Tokyo, Japan, 1358550
        • Local Institution - 0126
      • Minato-ku, Tokyo, Japan, 1058470
        • Local Institution - 0156
      • Shinagawa-ku, Tokyo, Japan, 142-8666
        • Local Institution - 0140
      • Shinjuku-Ku, Tokyo, Japan, 1608582
        • Local Institution - 0196
      • Shinjuku-ku, Tokyo, Japan, 1628666
        • Local Institution - 0155
      • Ōta-ku, Tokyo, Japan, 1438541
        • Local Institution - 0245
    • Toyama
      • Toyama, Toyama, Japan, 9300194
        • Local Institution - 0231
    • Wakayama
      • Wakayama, Wakayama, Japan, 641-8510
        • Local Institution - 0178
    • Yamaguchi
      • Ube-shi, Yamaguchi, Japan, 7558505
        • Local Institution - 0238
  • Mexico
    • Chiapas
      • Tuxtla Gutiérrez, Chiapas, Mexico, 29038
        • Local Institution - 0090
    • Mexico City
      • Mexico City, Mexico City, Mexico, 14000
        • Local Institution - 0102
    • San Luis Potosí
      • San Luis Potosí City, San Luis Potosí, Mexico, 78200
        • Local Institution - 0234
    • Yucatán
      • Mérida, Yucatán, Mexico, 97138
        • Local Institution - 0071
  • Peru
    • Lima Province
      • Lima, Lima Province, Peru, 34
        • Local Institution - 0060
      • Lima, Lima Province, Peru, Lima 11
        • Local Institution - 0093
    • Provincia Constitucional del Callao
      • Callao, Provincia Constitucional del Callao, Peru, 02
        • Local Institution - 0092
  • Poland
      • Lublin, Poland, 20-081
        • Local Institution - 0024
      • Warsaw, Poland, 02-781
        • Local Institution - 0022
  • Portugal
    • Porto District
      • Porto, Porto District, Portugal, 4200-072
        • Local Institution - 0243
  • Romania
      • Bucharest, Romania, 021389
        • Local Institution - 0081
      • Cluj-Napoca, Romania, 400015
        • Local Institution - 0079
      • Craiova, Romania, 200347
        • Local Institution - 0076
      • Suceava, Romania, 720237
        • Local Institution - 0080
  • Russia
      • Moscow, Russia, 121309
        • Local Institution - 0089
      • Saint Petersburg, Russia, 198255
        • Local Institution - 0088
  • Singapore
      • Singapore, Singapore, 119228
        • Local Institution - 0034
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 168583
        • Local Institution - 0033
  • South Korea
      • Busan, South Korea, 49241
        • Local Institution - 0166
      • Daegu, South Korea, 41404
        • Local Institution - 0150
      • Daejeon, South Korea, 35015
        • Local Institution - 0149
      • Jeonju, South Korea, 54907
        • Local Institution - 0236
      • Seoul, South Korea, 01812
        • Local Institution - 0235
      • Seoul, South Korea, 05505
        • Local Institution - 0130
      • Seoul, South Korea, 06351
        • Local Institution - 0177
      • Seoul, South Korea, 06591
        • Local Institution - 0168
      • Seoul, South Korea, 07345
        • Local Institution - 0151
      • Seoul, South Korea, 08308
        • Local Institution - 0131
      • Seoul, South Korea, 120-752
        • Local Institution - 0123
      • Ulsan, South Korea, 44033
        • Local Institution - 0157
    • Kyǒnggi-do
      • Seongnam-si, Kyǒnggi-do, South Korea, 13620
        • Local Institution - 0129
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 02841
        • Local Institution - 0165
  • Spain
      • Barcelona, Spain, 08035
        • Local Institution - 0063
      • Madrid, Spain, 28050
        • Local Institution - 0062
  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • Local Institution - 0167
      • Kaohsiung City, Taiwan, 833
        • Local Institution - 0133
      • Kaohsiung County, Taiwan
        • Local Institution - 0163
      • Keelung, Taiwan, 204
        • Local Institution - 0164
      • Taichung, Taiwan, 40447
        • Local Institution - 0132
      • Tainan, Taiwan, 71004
        • Local Institution - 0160
      • Taipei, Taiwan, 100
        • Local Institution - 0124
      • Taipei, Taiwan, 11217
        • Local Institution - 0134
      • Taipei, Taiwan, 10449
        • Local Institution - 0162
      • Taoyuan District, Taiwan, 333
        • Local Institution - 0159
    • Changhua
      • Changhua County, Changhua, Taiwan, 50006
        • Local Institution - 0158
    • TNN
      • Tainan, TNN, Taiwan, 704
        • Local Institution - 0161
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06100
        • Local Institution - 0096
      • Diyarbakır, Turkey (Türkiye), 21280
        • Local Institution - 0125
      • Edrine, Turkey (Türkiye), 22010
        • Local Institution - 0122
  • United Kingdom
      • London, United Kingdom, EC1A 7BE
        • Local Institution - 0237
      • Surrey, United Kingdom, SM2 5PT
        • Local Institution - 0029
    • Greater London
      • London, Greater London, United Kingdom, NW1 2PG
        • Local Institution - 0069
      • London, Greater London, United Kingdom, SW3 6JJ
        • Local Institution - 0066
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M20 4BX
        • Local Institution - 0031
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Local Institution - 0191
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center
    • California
      • Los Angeles, California, United States, 90033
        • USC/Norris Comprehensive Cancer Center
    • Colorado
      • Denver, Colorado, United States, 80218
        • Local Institution - 0188
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Sylvester Comprehensive Cancer Center
      • Miami, Florida, United States, 33176
        • Local Institution - 0186
      • Tampa, Florida, United States, 33612
        • Local Institution - 0225
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Local Institution - 0074
      • Marietta, Georgia, United States, 30060
        • Local Institution - 0032
    • New Jersey
      • Neptune City, New Jersey, United States, 07753
        • Hackensack Meridian Jersey Shore University Medical Center
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Oncology Associates Of Oregon, Pc
      • Portland, Oregon, United States, 97227
        • Northwest Cancer Specialists, P.C.
    • Texas
      • Dallas, Texas, United States, 75246
        • Local Institution - 0210
      • Houston, Texas, United States, 77030
        • Local Institution - 0028
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Local Institution - 0190
    • West Virginia
      • Morgantown, West Virginia, United States, 26506-9162
        • Local Institution - 0203

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:

  • Must have histologically confirmed squamous cell carcinoma or adenosquamous cell carcinoma of esophagus
  • Male or Female at least 18 years of age
  • Must have esophageal cancer that cannot be operated on, or treated with definitive chemoradiation with curative intent, that is advanced, reoccurring or has spread out
  • Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
  • Must agree to provide tumor tissue sample, either from a previous surgery or biopsy within 6 months or fresh, prior to the start of treatment in this study

Exclusion Criteria

  • Presence of tumor cells in the brain or spinal cord which are symptomatic or require treatment
  • Active known or suspected autoimmune disease
  • Any serious or uncontrolled medical disorder or active infection
  • Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  • Any positive test result for hepatitis B or C indicating acute or chronic infection and/or detectable virus

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: None (Open Label)

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: Nivolumab + Ipilimumab
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558 (Nivolumab)
  • Opdivo (Nivolumab)
Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016 (Ipilimumab)
  • Yervoy (Ipilimumab)
Experimental: Nivolumab + Cisplatin + Fluorouacil
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558 (Nivolumab)
  • Opdivo (Nivolumab)
Drug: Cisplatin
Specified dose on specified days
Drug: Fluorouracil
Specified dose on specified days
Active Comparator: Cisplatin + Fluorouracil
Drug: Cisplatin
Specified dose on specified days
Drug: Fluorouracil
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
Overall Survival (OS) in Participants With Tumor Cell PD-L1
Time Frame: From the date of randomization to up to the date of death (up to approximately 20 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 subject was known to be alive.
From the date of randomization to up to the date of death (up to approximately 20 months)
Progression-free Survival (PFS) as Assessed by BICR in Participants With Tumor Cell PD-L1
Time Frame: From the date of randomization to up to the date of the first documented disease progression or death (up to approximately 9 months)
Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented progressive disease (PD) per Blinded Independent Central Review (BICR) or death due to any cause. Participants who die without a reported prior PD per BICR (and die without start of subsequent therapy) will be considered to have progressed on the date of death. Participants who did not have documented PD per BICR per RECIST1.1 criteria and who did not die, will be censored at the date of the last evaluable tumor assessment on or prior to initiation of the subsequent anti-cancer therapy. Participants who did not have any on-study tumor assessments and did not die (or died after initiation of the subsequent anti-cancer therapy) will be censored at the randomization date. Participants who started any subsequent anti-cancer therapy without a prior reported PD per BICR will be censored at the last tumor assessment on or prior to initiation of the subsequent anti-cancer therapy.
From the date of randomization to up to the date of the first documented disease progression or death (up to approximately 9 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) in All Randomized Participants
Time Frame: From the date of randomization to up to the date of death (up to approximately 88 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 subject was known to be alive.
From the date of randomization to up to the date of death (up to approximately 88 months)
Progression-free Survival (PFS) in All Randomized Participants as Assessed by BICR
Time Frame: From the date of randomization to up to the date of the first documented disease progression or death (up to approximately 88 months)
Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented progressive disease (PD) per Blinded Independent Central Review (BICR) or death due to any cause. Participants who die without a reported prior PD per BICR (and die without start of subsequent therapy) will be considered to have progressed on the date of death. Participants who did not have documented PD per BICR per RECIST1.1 criteria and who did not die, will be censored at the date of the last evaluable tumor assessment on or prior to initiation of the subsequent anti-cancer therapy. Participants who did not have any on-study tumor assessments and did not die (or died after initiation of the subsequent anti-cancer therapy) will be censored at the randomization date. Participants who started any subsequent anti-cancer therapy without a prior reported PD per BICR will be censored at the last tumor assessment on or prior to initiation of the subsequent anti-cancer therapy.
From the date of randomization to up to the date of the first documented disease progression or death (up to approximately 88 months)
Objective Response Rate (ORR) as Assessed by BICR
Time Frame: From the date of randomization to up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to 88 months)
Objective response rate (ORR) is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). Best overall response (BOR) is defined as the best response designation as determined by BICR, recorded between the date of randomization and the date of objectively documented progression (per RECIST 1.1) or the date of subsequent anti-cancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurs first. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions. Complete response is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to <10 mm.
From the date of randomization to up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to 88 months)

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

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ono Pharmaceutical Co. Ltd

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.
June 29, 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.
January 18, 2021

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.
January 13, 2025

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 4, 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 4, 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 8, 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.
February 17, 2026

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.
February 13, 2026

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.
February 1, 2026

More Information

Terms related to this study

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.
  • CA209-648
  • 2016-001514-20 (EudraCT Number)

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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