A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC (CheckMate 9LA)

December 2, 2025 updated by: Bristol-Myers Squibb

A Phase 3, Randomized Study of Nivolumab Plus Ipilimumab in Combination With Chemotherapy vs Chemotherapy Alone as First Line Therapy in Stage IV Non-Small Cell Lung Cancer

The purpose of this study is to determine whether Nivolumab, Ipilimumab combined with chemotherapy is more effective than chemotherapy by itself when treating stage IV NSCLC as the first treatment given for the disease

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.
719

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
      • Córdoba, Argentina, 5000
        • Local Institution - 0030
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
        • Local Institution - 0014
    • Córdoba Province
      • Río Cuarto, Córdoba Province, Argentina, 5800
        • Local Institution - 0028
    • Río Negro Province
      • Viedma, Río Negro Province, Argentina, 8500
        • Local Institution - 0026
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000DSV
        • Local Institution - 0027
  • Australia
    • New South Wales
      • Gosford, New South Wales, Australia, 2250
        • Local Institution - 0086
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Local Institution - 0040
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Local Institution - 0089
      • Heidelberg, Victoria, Australia, 3084
        • Local Institution - 0036
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Local Institution - 0078
  • Belgium
      • Gilly, Belgium, 6060
        • Local Institution - 0002
      • Leuven, Belgium, 3000
        • Local Institution - 0033
      • Roeselare, Belgium, 8800
        • Local Institution - 0001
  • Brazil
      • Rio de Janeiro, Brazil, 20231-050
        • Local Institution - 0066
      • São Paulo, Brazil, 01327-001
        • Local Institution - 0070
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59075-740
        • Local Institution - 0068
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brazil, 98700-000
        • Local Institution - 0063
      • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
        • Local Institution - 0067
    • Santa Catarina
      • Blumenau, Santa Catarina, Brazil, 89010-340
        • Local Institution - 0069
    • São Paulo
      • Barretos, São Paulo, Brazil, 14780-070
        • Local Institution - 0064
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Local Institution - 0065
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Local Institution - 0090
      • Montreal, Quebec, Canada, H3T 1E2
        • Local Institution - 0083
      • Montreal, Quebec, Canada, H4A 3J1
        • Local Institution - 0082
      • Rimouski, Quebec, Canada, G5L 5T1
        • Local Institution - 0080
  • Chile
    • Región de Valparaíso
      • Viña del Mar, Región de Valparaíso, Chile, 2520612
        • Local Institution - 0079
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 7500921
        • Local Institution - 0059
      • Santiago, Santiago Metropolitan, Chile, 8420383
        • Local Institution - 0084
  • China
      • Beijing, China, 102206
        • Local Institution - 0113
      • Shanghai, China, 200030
        • Local Institution - 0112
    • BEI
      • Beijing, BEI, China, 100142
        • Local Institution - 0139
    • Hainan
      • Haikou, Hainan, China, 570311
        • Local Institution - 0146
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Local Institution - 0148
      • Zhengzhou, Henan, China, 450052
        • Local Institution - 0120
    • Hunan
      • Changsha, Hunan, China, 410000
        • Local Institution - 0144
    • Jilin
      • Changchun, Jilin, China, 130012
        • Local Institution - 0106
    • Shan3xi
      • Xi'an, Shan3xi, China, 710038
        • Local Institution - 0108
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Local Institution - 0110
      • Zhejiang, Zhejiang, China, 310022
        • Local Institution - 0111
  • France
      • Caen, France, 14033
        • Local Institution - 0013
      • Lille, France, 59037
        • Local Institution - 0071
      • Montpellier, France, 34295
        • Local Institution - 0012
      • Nantes, France, 44093
        • Local Institution - 0035
      • Paris, France, 75970
        • Local Institution - 0011
      • Saint-Brieuc, France, 22027
        • Local Institution - 0097
    • Auvergne-Rhône-Alpes
      • Bron, Auvergne-Rhône-Alpes, France, 69500
        • Local Institution - 0010
      • Lyon Cedex08, Auvergne-Rhône-Alpes, France, 69373
        • Local Institution - 0009
  • Germany
      • Berlin, Germany, 14165
        • Local Institution - 0073
      • Gauting, Germany, 82131
        • Local Institution - 0016
      • Großhansdorf, Germany, 22927
        • Local Institution - 0072
      • Hemer, Germany, 58675
        • Local Institution - 0019
      • Immenhausen, Germany, 34376
        • Local Institution - 0017
      • Magdeburg, Germany, 39120
        • Local Institution - 0074
      • München, Germany, 81925
        • Local Institution - 0015
      • Stuttgart, Germany, 70376
        • Local Institution - 0018
  • Ireland
      • Dublin, Ireland, 8
        • Local Institution - 0021
      • Limerick, Ireland, V94 F858
        • Local Institution - 0020
  • Italy
      • Lucca, Italy, 5510
        • Local Institution - 0042
      • Milan, Italy, 20132
        • Local Institution - 0041
      • Napoli, Italy, 80131
        • Local Institution - 0043
  • Japan
      • Osaka, Japan, 545-8586
        • Local Institution - 0130
    • Fukushima
      • Fukushima, Fukushima, Japan, 9601295
        • Local Institution - 0101
    • Gunma
      • Maebashi, Gunma, Japan, 3718511
        • Local Institution - 0118
      • Ota-shi, Gunma, Japan, 3738550
        • Local Institution - 0128
    • Hiroshima
      • Hiroshima, Hiroshima, Japan, 7308518
        • Local Institution - 0138
      • Hiroshima, Hiroshima, Japan, 7348511
        • Local Institution - 0137
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 0608648
        • Local Institution - 0127
    • Hyōgo
      • Akashi-shi, Hyōgo, Japan, 6738558
        • Local Institution - 0131
      • Himeji-shi, Hyōgo, Japan, 6708520
        • Local Institution - 0119
      • Kobe, Hyōgo, Japan, 6500047
        • Local Institution - 0104
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 9208641
        • Local Institution - 0115
    • Iwate
      • Shiwa-gun, Iwate, Japan, 0283695
        • Local Institution - 0100
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 2210855
        • Local Institution - 0129
      • Yokohama, Kanagawa, Japan, 2360051
        • Local Institution - 0114
      • Yokohama, Kanagawa, Japan, 2418515
        • Local Institution - 0134
    • Niigata
      • Niigata, Niigata, Japan, 9518566
        • Local Institution - 0116
    • Okayama-ken
      • Okayama, Okayama-ken, Japan, 7008558
        • Local Institution - 0136
    • Osaka
      • Habikino-shi, Osaka, Japan, 5838588
        • Local Institution - 0135
      • Ōsaka-sayama, Osaka, Japan, 5898511
        • Local Institution - 0103
    • Saitama
      • Kitaadachi-gun, Saitama, Japan, 3620806
        • Local Institution - 0102
    • Yamaguchi
      • Ube-shi, Yamaguchi, Japan, 7550241
        • Local Institution - 0132
  • Mexico
      • Veracruz, Veracruz, Mexico, 91900
        • Local Institution - 0075
    • BAJA Californa SUR
      • La Paz, BAJA Californa SUR, Mexico, 23040
        • Local Institution - 0077
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • Local Institution - 0061
  • Poland
      • Bydgoszcz, Poland, 85-796
        • Local Institution - 0087
      • Bytom, Poland, 41-902
        • Local Institution - 0022
      • Gdansk, Poland, 80-952
        • Local Institution - 0085
  • Romania
      • Bucharest, Romania, 020122
        • Local Institution - 0034
      • Cluj-Napoca, Romania, 400015
        • Local Institution - 0031
      • Craiova, Romania, 200542
        • Local Institution - 0032
  • Russia
      • Moscow, Russia, 115478
        • Local Institution - 0024
      • Saint Petersburg, Russia, 197758
        • Local Institution - 0025
  • Spain
      • A Coruña, Spain, 15006
        • Local Institution - 0054
      • Barcelona, Spain, 08035
        • Local Institution - 0053
      • Madrid, Spain, 28041
        • Local Institution - 0052
      • Málaga, Spain, 29010
        • Local Institution - 0055
      • Valencia, Spain, 46026
        • Local Institution - 0056
  • United Kingdom
      • Guildford, United Kingdom, GU2 7XX
        • Local Institution - 0050
      • London, United Kingdom, SE1 9RT
        • Local Institution - 0049
      • Tauton, United Kingdom, TA1 5DA
        • Local Institution - 0048
  • United States
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Memorial Health Systems
    • Connecticut
      • Plainville, Connecticut, United States, 06062
        • Local Institution - 0044
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Local Institution - 0045
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Local Institution - 0029
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Local Institution - 0091
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Local Institution - 0004
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Local Institution - 0105
    • New York
      • Johnson City, New York, United States, 13790
        • Local Institution - 0058
      • Mineola, New York, United States, 11501
        • Local Institution - 0098
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Local Institution - 0095
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17602
        • Local Institution - 0006
      • Pittsburgh, Pennsylvania, United States, 15224
        • Local Institution - 0093
      • Pittsburgh, Pennsylvania, United States, 15213
        • Local Institution - 0047
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Local Institution - 0094
    • Utah
      • St. George, Utah, United States, 84770
        • Southwest Regional Cancer Clinic
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Local Institution - 0099

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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Participants with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
  • Measurable disease by CT or MRI per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) criteria
  • Participants must have PD-L1 IHC testing with results performed by a central laboratory during the screening period

Exclusion Criteria:

  • Participants with known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy (including, but not limited to, deletions in exon 19 and exon 21 [L858R] substitution mutations) are excluded
  • Participants with known anaplastic lymphoma kinase (ALK) translocations which are sensitive to available targeted inhibitor therapy are excluded
  • Participants with untreated CNS metastases are excluded. Participants are eligible if CNS metastases are adequately treated and participants are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to first treatment

Other protocol inclusion/exclusion criteria may 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: Module A
Chemotherapy/Biologics combined
Biological: Ipilimumab
Specified dose on specified day
Other Names:
  • Yervoy, BMS734016
Biological: Nivolumab
Specified dose on specified day
Other Names:
  • Opdivo, BMS936558
Drug: Carboplatin
Specified dose on specified day
Drug: Paclitaxel
Specified dose on specified day
Other Names:
  • Taxol
Drug: Pemetrexed
Specified dose on specified day
Other Names:
  • Alimta
Drug: Cisplatin
Specified dose on specified day
Other Names:
  • Platinol
Active Comparator: Module B
Chemotherapy Combination
Drug: Carboplatin
Specified dose on specified day
Drug: Paclitaxel
Specified dose on specified day
Other Names:
  • Taxol
Drug: Pemetrexed
Specified dose on specified day
Other Names:
  • Alimta
Drug: Cisplatin
Specified dose on specified day
Other Names:
  • Platinol

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)
Time Frame: From date of randomization to date of death (assessed up to October 2019, approximately 23 months)
OS was defined as the time from randomization to the date of death from any cause. OS was censored on the last date a subject was known to be alive. Survival follow-up was to be conducted every 3 months after participants's off-treatment date.
From date of randomization to date of death (assessed up to October 2019, approximately 23 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
Progression Free Survival (PFS) by BICR
Time Frame: From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)
PFS (primary definition) was defined as the time from the randomization date to the date of the first documented tumor progression based on BICR assessment (per RECIST 1.1), or death from any cause, whichever occurred first. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Participants who had not progressed or died were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the randomization date. Participants who started any palliative local therapy or subsequent anticancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to initiation of the palliative local therapy or subsequent anti-cancer therapy, whichever procedure occurred first.
From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)
Objective Response Rate (ORR) by BICR
Time Frame: From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)
ORR was defined as the number of randomized participants with a best overall response (BOR) of confirmed CR or PR based on BICR assessments (using RECIST v1.1 criteria), divided by the number of all randomized participants. BOR was recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of initiation of palliative local therapy or the date of initiation of subsequent anti-cancer therapy, whichever occurred first. For participants without documented progression or palliative local therapy or subsequent anti-cancer therapy, all available response designations contributed to the BOR determination. For participants who continued treatment beyond progression, the BOR was determined based on response designations recorded up to the time of the initial RECIST 1.1 defined progression.
From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)
Duration of Response (DoR)
Time Frame: From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)
DoR was defined as the time between the date of first confirmed documented response (CR or PR) to the date of the first documented BICR-assessed tumor progression (per RECIST 1.1), or death from any cause, whichever occurred first. Participants who started subsequent therapy (including palliative local therapy) without a prior reported progression were censored at the last evaluable tumor assessments prior to initiation of the subsequent anticancer therapy (including palliative local therapy). Participants who died without a reported prior progression were considered to have progressed on the date of their death. For subjects who neither progressed nor died, DoR was censored on the date of their last evaluable tumor assessment. DoR was evaluated for responders (confirmed CR or PR) only.
From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)
Time to Response (TTR)
Time Frame: From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)
TTR was defined as the time from randomization to the date of the first confirmed documented response (CR or PR), as assessed by the BICR. TTR was evaluated for responders (confirmed CR or PR) only.
From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)
Objective Response Rate (ORR) by BICR by PD-LI Tumor Cell Expression
Time Frame: From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)
ORR was defined as the proportion of randomized participants with a best overall response (BOR) of confirmed complete or partial response per BICR using RECIST v1.1. BOR was assessed from randomization until documented progression, start of palliative local or subsequent anti-cancer therapy-whichever came first. If none occurred, all response data contributed to BOR. For those treated beyond progression, BOR was based on responses before initial RECIST-defined progression. PD-L1 expression was measured via Dako PD-L1 IHC 28-8 pharmDx test as the percentage of tumor cells with membrane staining among ≥100 evaluable cells. Expression was categorized as ≥1%, <1%, not quantifiable, ≥50%, or 1-49%.
From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)
PFS by BICR by PD-L1 Tumor Cell Expression
Time Frame: From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)
PFS (primary definition) was defined as the time from the randomization date to the date of the first documented tumor progression based on BICR assessment (per RECIST 1.1), or death from any cause, whichever occurred first. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Participants who had not progressed or died were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the randomization date. Participants who started any palliative local therapy or subsequent anticancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to initiation of the palliative local therapy or subsequent anti-cancer therapy, whichever procedure occurred first.
From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)
OS by PD-L1 Tumor Cell Expression
Time Frame: From date of randomization to date of death (assessed up to October 2024, approximately 72 months)
OS was defined as the time from randomization to the date of death from any cause. OS was censored on the last date a subject was known to be alive. Survival follow-up was to be conducted every 3 months after participants's off-treatment date.
From date of randomization to date of death (assessed up to October 2024, approximately 72 months)
PFS by BICR by Tumor Mutational Burden
Time Frame: From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)
PFS (primary definition) was defined as the time from the randomization date to the date of the first documented tumor progression based on BICR assessment (per RECIST 1.1), or death from any cause, whichever occurred first. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Participants who had not progressed or died were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the randomization date. Participants who started any palliative local therapy or subsequent anticancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to initiation of the palliative local therapy or subsequent anti-cancer therapy, whichever procedure occurred first.
From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)
ORR by BICR by Tumor Mutational Burden
Time Frame: From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)
ORR was defined as the number of randomized participants with a best overall response (BOR) of confirmed CR or PR based on BICR assessments (using RECIST v1.1 criteria), divided by the number of all randomized participants. BOR was recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of initiation of palliative local therapy or the date of initiation of subsequent anti-cancer therapy, whichever occurred first. For participants without documented progression or palliative local therapy or subsequent anti-cancer therapy, all available response designations contributed to the BOR determination. For participants who continued treatment beyond progression, the BOR was determined based on response designations recorded up to the time of the initial RECIST 1.1 defined progression.
From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)
OS by Tumor Mutational Burden
Time Frame: From date of randomization to date of death (assessed up to October 2024, approximately 72 months)
OS was defined as the time from randomization to the date of death from any cause. OS was censored on the last date a subject was known to be alive. Survival follow-up was to be conducted every 3 months after participants's off-treatment date.
From date of randomization to date of death (assessed up to October 2024, approximately 72 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

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.
August 24, 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.
August 16, 2019

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.
October 18, 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).
July 11, 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.
July 11, 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.
July 12, 2017

Study Record Updates

Last Update Posted (Estimated)

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.
December 17, 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.
December 2, 2025

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.
December 1, 2025

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.
  • CA209-9LA
  • 2017-001195-35 (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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