Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer (CheckMate649)

November 30, 2023 updated by: Bristol-Myers Squibb

A Randomized, Multicenter, Open-Label, Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab in Combination With Oxaliplatin Plus Fluoropyrimidine Versus Oxaliplatin Plus Fluoropyrimidine in Subjects With Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer

The main purpose of this study is to compare how long patients with gastric or gastroesophageal junction cancer live after receiving nivolumab and ipilimumab or nivolumab and chemotherapy compared with patients receiving chemotherapy alone.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2031

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
      • Cordoba, Argentina, 5000
        • Local Institution - 0027
      • La Rioja, Argentina, 5300
        • Local Institution - 0184
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, 1426
        • Local Institution - 0030
      • Capital Federal, Buenos Aires, Argentina, 1264
        • Local Institution - 0028
      • Capital Federal, Buenos Aires, Argentina, 1280
        • Local Institution - 0029
    • RIO Negro
      • Viedma, RIO Negro, Argentina, 8500
        • Local Institution - 0183
    • Tucuman
      • San Miguel De Tucuman, Tucuman, Argentina, 4000
        • Local Institution - 0026
  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Local Institution - 0202
      • Gosford, New South Wales, Australia, 2250
        • Local Institution - 0100
    • Queensland
      • Southport, Queensland, Australia, 4215
        • Local Institution - 0190
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Local Institution - 0101
    • Victoria
      • Ballarat, Victoria, Australia, 3350
        • Local Institution - 0103
      • Shepparton, Victoria, Australia, 3630
        • Local Institution - 0102
      • St Albans, Victoria, Australia, 3021
        • Local Institution - 0214
    • Western Australia
      • Perth, Western Australia, Australia, 6150
        • Local Institution - 0099
  • Brazil
      • Sao Paulo, Brazil, 01246-000
        • Local Institution - 0054
    • Bahia
      • Salvador, Bahia, Brazil, 41950-610
        • Local Institution - 0053
    • RIO Grande DO SUL
      • Ijui, RIO Grande DO SUL, Brazil, 98700-000
        • Local Institution - 0046
      • Porto Alegre, RIO Grande DO SUL, Brazil, 90035-903
        • Local Institution - 0047
    • Sao Paulo
      • Barretos, Sao Paulo, Brazil, 14784-400
        • Local Institution - 0048
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Local Institution - 0035
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • Local Institution - 0036
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution - 0067
    • Quebec
      • Montreal, Quebec, Canada, H2X 3E4
        • Local Institution - 0052
      • Montreal, Quebec, Canada, H3T 1E2
        • Local Institution - 0196
      • Quebec City, Quebec, Canada, G1J 1Z4
        • Local Institution - 0051
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Local Institution - 0068
      • Trois-Rivieres, Quebec, Canada, G8Z 3R9
        • Local Institution - 0034
  • Chile
    • Araucania
      • Temuco, Araucania, Chile, 4800827
        • Local Institution - 0032
    • Metropolitana
      • Santiago, Metropolitana, Chile, 8320000
        • Local Institution - 0057
      • Santiago, Metropolitana, Chile
        • Local Institution - 0031
    • Santiago
      • Independencia, Santiago, Chile
        • Local Institution - 0058
    • Valparaiso
      • Vina Del Mar, Valparaiso, Chile, 2540364
        • Local Institution - 0033
  • China
      • Hangzhou, China, 310016
        • Local Institution - 0174
      • Tianjin, China, 300060
        • Local Institution - 0172
    • Beijing
      • Beijing, Beijing, China, 100001
        • Local Institution - 0176
      • Beijing, Beijing, China, 100032
        • Local Institution - 0178
      • Beijing, Beijing, China, 100142
        • Local Institution - 0171
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Local Institution - 0185
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Local Institution - 0166
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Local Institution - 0160
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Local Institution - 0159
    • Hunan
      • Changsha, Hunan, China, 410013
        • Local Institution - 0173
    • Jiangsu
      • Changzhou, Jiangsu, China, 213003
        • Local Institution - 0158
      • Nanjing, Jiangsu, China, 210000
        • Local Institution - 0187
      • Nanjing, Jiangsu, China, 210002
        • Local Institution - 0154
    • Jilin
      • Changchun, Jilin, China, 130012
        • Local Institution - 0156
      • Changchun, Jilin, China, 130021
        • Local Institution - 0155
    • Liaoning
      • Shenyang, Liaoning, China, 110046
        • Local Institution - 0181
    • Shandong
      • Qingdao, Shandong, China, 266061
        • Local Institution - 0182
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Local Institution - 0165
      • Shanghai, Shanghai, China, 200032
        • Local Institution - 0175
    • Xinjiang
      • Urumqi, Xinjiang, China, 830011
        • Local Institution - 0167
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Local Institution - 0161
      • Hangzhou, Zhejiang, China, 310022
        • Local Institution - 0168
  • Colombia
      • Bogota, Colombia
        • Local Institution - 0022
      • Pasto, Colombia
        • Local Institution - 0024
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia
        • Local Institution - 0025
  • Czechia
      • Brno, Czechia, 625 00
        • Local Institution - 0200
      • Brno, Czechia, 656 53
        • Local Institution - 0197
  • France
      • Caen, France, 14000
        • Local Institution - 0080
      • Dijon, France, 21000
        • Local Institution - 0081
      • Lille, France, 59000
        • Local Institution - 0077
      • Montpellier, France, 34090
        • Local Institution - 0083
      • Nantes, France, 44000
        • Local Institution - 0113
      • Nice Cedex 2, France, 06189
        • Local Institution - 0079
      • Paris, France, 75012
        • Local Institution - 0078
      • Plérin, France, 22190
        • Local Institution - 0119
  • Germany
      • Berlin, Germany, 13353
        • Local Institution - 0094
      • Cologne, Germany, 50937
        • Local Institution - 0095
      • Dresden, Germany, 01307
        • Local Institution - 0089
      • Dusseldorf, Germany, 40225
        • Local Institution - 0188
      • Essen, Germany, 45122
        • Local Institution - 0091
      • Freiburg, Germany, 79106
        • Local Institution - 0096
      • Hamburg, Germany, 20251
        • Local Institution - 0093
      • Muenchen, Germany, 81675
        • Local Institution - 0149
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • Local Institution - 0092
  • Greece
      • Athens, Greece, 11526
        • Local Institution - 0056
      • Ioannina, Greece, 45500
        • Local Institution - 0019
      • Patras, Greece, 26504
        • Local Institution - 0018
    • Attikí
      • Nea Kifissia, Attikí, Greece, 14564
        • Local Institution - 0017
  • Hong Kong
      • Hong Kong, Hong Kong
        • Local Institution - 0191
      • Hong Kong, Hong Kong
        • Local Institution - 0195
  • Hungary
      • Budapest, Hungary, 1122
        • Local Institution - 0007
      • Budapest, Hungary, 1083
        • Local Institution - 0008
      • Debrecen, Hungary
        • Local Institution - 0108
  • Israel
      • Haifa, Israel, 31096
        • Local Institution - 0118
      • Jerusalem, Israel, 91120
        • Local Institution - 0116
      • Petach Tikva, Israel, 49100
        • Local Institution - 0115
      • Ramat-gan, Israel, 52621
        • Local Institution - 0117
      • Tel Aviv, Israel, 64239
        • Local Institution - 0114
  • Italy
      • Bergamo, Italy, 24127
        • Local Institution - 0062
      • Modena, Italy, 41124
        • Local Institution - 0205
      • Napoli, Italy, 80131
        • Local Institution - 0061
      • Pisa, Italy, 56126
        • Local Institution - 0063
      • Roma, Italy, 00168
        • Local Institution - 0059
      • San Giovanni Rotondo, Italy, 71013
        • Local Institution - 0064
  • Japan
      • Tokyo, Japan, 1358550
        • Local Institution - 0129
    • Aichi
      • Nagoya, Aichi, Japan, 4648681
        • Local Institution - 0130
    • Chiba
      • Chiba-shi, Chiba, Japan, 260-8717
        • Local Institution - 0128
      • Kashiwa, Chiba, Japan, 277-8577
        • Local Institution - 0125
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan, 0608648
        • Local Institution - 0137
    • Kagawa
      • Kita-Gun, Kagawa, Japan, 7610793
        • Local Institution - 0127
    • Osaka
      • Suita-shi, Osaka, Japan, 565-0871
        • Local Institution - 0124
    • Saitama
      • Kitaadachi-gun, Saitama, Japan, 3620806
        • Local Institution - 0123
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 1040045
        • Local Institution - 0126
      • Minato-ku, Tokyo, Japan, 1058470
        • Local Institution - 0122
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Local Institution - 0132
      • Seoul, Korea, Republic of, 05505
        • Local Institution - 0131
  • Mexico
      • Queretaro, Mexico, 76090
        • Local Institution - 0216
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 03100
        • Local Institution - 0215
    • Estado DE Mexico
      • Toluca, Estado DE Mexico, Mexico, 50120
        • Local Institution - 0217
  • Peru
      • Lima, Peru, 27
        • Local Institution - 0189
      • Lima, Peru, 34
        • Local Institution - 0039
      • Lima, Peru, LIMA 31
        • Local Institution - 0037
      • Lima, Peru, Lima 41
        • Local Institution - 0139
  • Poland
      • Lublin, Poland, 20-081
        • Local Institution - 0016
      • Tarnobrzeg, Poland, 39-400
        • Local Institution - 0013
      • Warszawa, Poland, 02-034
        • Local Institution - 0014
  • Portugal
      • Lisboa, Portugal, 1649-035
        • Local Institution - 0043
      • Porto, Portugal, 4200-072
        • Local Institution - 0210
  • Romania
      • Bucharest, Romania, 022328
        • Local Institution - 0040
      • Cluj-Napoca, Romania, 400015
        • Local Institution - 0042
      • Suceava, Romania, 720237
        • Local Institution - 0055
    • Dolj
      • Craiova, Dolj, Romania, 200542
        • Local Institution - 0041
    • Jud Maramures
      • Baia Mare, Jud Maramures, Romania, 430291
        • Local Institution - 0012
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454048
        • Local Institution - 0071
      • Moscow, Russian Federation, 115478
        • Local Institution - 0086
      • Moscow, Russian Federation, 121309
        • Local Institution - 0069
      • Moscow, Russian Federation, 125284
        • Local Institution - 0105
      • St. Petersburg, Russian Federation, 198255
        • Local Institution - 0085
  • Singapore
      • Singapore, Singapore, 119228
        • Local Institution - 0194
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 168583
        • Local Institution - 0193
  • Spain
      • Badajoz, Spain, 06006
        • Local Institution - 0050
      • Badalona-barcelona, Spain, 08916
        • Local Institution - 0209
      • Barcelona, Spain, 08035
        • Local Institution - 0044
      • Pozuelo De Alarcon, Madrid, Spain, 28223
        • Local Institution - 0049
      • Valencia, Spain, 46010
        • Local Institution - 0045
      • Zaragoza, Spain, 50009
        • Local Institution - 0212
  • Taiwan
      • Tainan, Taiwan, 70403
        • Local Institution - 0148
      • Taipei, Taiwan, 11217
        • Local Institution - 0133
      • Taoyuan County, Taiwan, 333
        • Local Institution - 0134
  • Turkey
      • Ankara, Turkey, 06800
        • Local Institution - 0203
      • Ankara, Turkey, 06800
        • Local Institution - 0211
      • Antalya, Turkey, 07070
        • Local Institution - 0201
      • Diyarbakır, Turkey, 21280
        • Local Institution - 0208
      • Edrine, Turkey, 22010
        • Local Institution - 0207
  • United Kingdom
      • Southampton, United Kingdom, SO16 6YD
        • Local Institution - 0072
    • Greater London
      • London, Greater London, United Kingdom, SW3 6JJ
        • Local Institution - 0074
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M20 4BX
        • Local Institution - 0073
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • Local Institution - 0076
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Local Institution - 0075
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Local Institution - 0005
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center Research Institute
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Local Institution - 0066
      • Denver, Colorado, United States, 80218
        • Local Institution - 0151
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Local Institution - 0136
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Florida Cancer Specialists S.
      • Miami, Florida, United States, 33176
        • Local Institution - 0147
      • Saint Petersburg, Florida, United States, 33705
        • Florida Cancer Specialists
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Local Institution - 0179
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Local Institution - 0219
      • Chicago, Illinois, United States, 60611
        • Local Institution - 0120
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Local Institution - 0021
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 0002
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 0135
    • New York
      • New York, New York, United States, 10065
        • Local Institution - 0003
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Local Institution - 0138
      • Cleveland, Ohio, United States, 44195
        • Local Institution - 0186
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Local Institution - 0146
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18105
        • Lehigh Valley Health Network
      • Pittsburgh, Pennsylvania, United States, 15224
        • Local Institution - 0065
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Local Institution - 0104
    • Texas
      • Bedford, Texas, United States, 76022
        • Local Institution - 0140
      • Dallas, Texas, United States, 75230
        • Local Institution - 0143
      • Dallas, Texas, United States, 75246
        • Local Institution - 0213
      • Houston, Texas, United States, 77030
        • Local Institution - 0004
      • Plano, Texas, United States, 75075-7787
        • Texas Oncology-Plano East
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Local Institution - 0150

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:

  • Male or Female at least 18 years of age
  • Must have gastric cancer or gastroesophageal junction cancer that cannot be operated on and that is advanced or has spread out
  • Did not receive neoadjuvant or adjuvant treatment (chemotherapy, radiotherapy, or both) for their disease within the last 6 months
  • 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 that have not been treated
  • 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

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
Intervention / Treatment
Experimental: Nivolumab + Ipilimumab

Nivolumab + Ipilimumab for 4 doses, followed by Nivolumab monotherapy

Enrollment is closed for this arm
Drug: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Active Comparator: XELOX (Oxaliplatin + Capecitabine)
Drug: Oxaliplatin
Specified dose on specified days
Drug: Capecitabine
Specified dose on specified days
Active Comparator: FOLFOX (Oxaliplatin + Leucovorin + Fluorouracil)
Drug: Fluorouracil
Specified dose on specified days
Drug: Oxaliplatin
Specified dose on specified days
Drug: Leucovorin
Specified dose on specified days
Experimental: Nivolumab + XELOX
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: Oxaliplatin
Specified dose on specified days
Drug: Capecitabine
Specified dose on specified days
Experimental: Nivolumab + FOLFOX
Drug: Fluorouracil
Specified dose on specified days
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: Oxaliplatin
Specified dose on specified days
Drug: Leucovorin
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5
Time Frame: From the date of randomization up to the date of death, up to approximately 17 months
Overall survival (OS), defined as the time from randomization to the time of death, in participants treated with Nivolumab plus Chemotherapy vs Chemotherapy with PD-L1 CPS (combined positive score) ≥ 5. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.
From the date of randomization up to the date of death, up to approximately 17 months
Progression Free Survival (PFS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5
Time Frame: From randomization to the date of the first documented progressive disease (PD) per BICR or death due to any cause (up to approximately 10 months)
Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented PD or death due to any cause. PD is determined by blinded independent committee review (BICR) per RECIST1.1 criteria in participants treated with Nivolumab plus Chemotherapy vs Chemotherapy with PD-L1 CPS ≥ 5. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking in reference the smallest sum on study that also demonstrated an absolute increase of at least 5 mm. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.
From randomization to the date of the first documented progressive disease (PD) per BICR or death due to any cause (up to approximately 10 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
Time Frame: From the date of randomization up to the date of death, up to approximately 17 months
Overall survival (OS), defined as the time from randomization to the time of death, in participants treated with Nivolumab plus Chemotherapy vs Chemotherapy with PD-L1 CPS ≥ 1, 10, and all randomized participants. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.
From the date of randomization up to the date of death, up to approximately 17 months
PFS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
Time Frame: From randomization to the date of the first documented progressive disease (PD) per BICR or death due to any cause (up to approximately 10 months)
Progression free survival (PFS), defined as the time from randomization to the date of the first documented progressive disease (PD) or death due to any cause, in participants treated with Nivolumab plus Chemotherapy vs Chemotherapy by BICR per RECIST1.1 in participants with PD-L1 CPS ≥ 10, 1, or all randomized subjects. Progreessive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking in reference the smallest sum on study that also demonstrated an absolute increase of at least 5 mm. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.
From randomization to the date of the first documented progressive disease (PD) per BICR or death due to any cause (up to approximately 10 months)
Objective Response Rate
Time Frame: From randomization to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 43 months)
Objective response rate (ORR) as assessed by BICR in participants with PD-L1 CPS ≥ 10, 5, 1, or all randomized participants. ORR is a percentage of participants determined by the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of measurable participants with target lesion at baseline. BOR is defined as the best response designation as determined by the BICR, recorded between the date of randomization and the date of objectively documented progression (per RECIST 1.1 as determined by the BICR) or the date of subsequent anti-cancer therapy, whichever occurs first. CR is defined as the disappearance of all target lesions. PR is define as at 30% decrease in the sum of diameters of target lesions. The 806 chemotherapy treated participants are split into two separate arms (Arm 2a and Arm 2b) to act as comparison groups to the other treatment arms.
From randomization to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 43 months)
OS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy
Time Frame: From the date of randomization up to the date of death, up to approximately 14 months
Overall survival (OS), defined as the time from randomization to the time of death, in participants treated with Nivolumab plus Ipilimumab vs Chemotherapy with PD-L1 CPS (combined positive score) ≥ 1, 5, 10, and all randomized participants. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.
From the date of randomization up to the date of death, up to approximately 14 months
Time to Symptom Deterioration (TTSD)
Time Frame: From randomization until a clinically meaningful decline from baseline in GaCS score
TTSD is defined as the the time from randomization until a clinically meaningful decline from baseline in Gastric Cancer Subscale (GaCS) score. A clinically meaningful deterioration is defined as a reduction of 8.2 points in the GaCS score. Subjects who do not deteriorate will be censored at the time of their last GACS assessment. Subjects without baseline GaCS assessment will be censored on the randomization date. Those with baseline GaCS, who do not have any GaCS assessments after randomization will be censored on the day after randomization.
From randomization until a clinically meaningful decline from baseline in GaCS score
PFS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy
Time Frame: From randomization to the date of the first documented progressive disease (PD) per BICR or death due to any cause (up to approximately 9 months)
Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented PD or death due to any cause. PD is determined by blinded independent committee review (BICR) per RECIST1.1 criteria in participants treated with Nivolumab plus Ipilumab vs Chemotherapy with PD-L1 CPS ≥ 10, 5, 1 or all randomized participants. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking in reference the smallest sum on study that also demonstrated an absolute increase of at least 5 mm. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.
From randomization to the date of the first documented progressive disease (PD) per BICR or death due to any cause (up to approximately 9 months)

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

Collaborators

Ono Pharmaceutical Co. Ltd

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)

October 12, 2016

Primary Completion (Actual)

May 27, 2020

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

August 16, 2016

First Submitted That Met QC Criteria

August 18, 2016

First Posted (Estimated)

August 19, 2016

Study Record Updates

Last Update Posted (Estimated)

December 4, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-649
  • 2016-001018-76 (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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