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CompletedNCT02864251CheckMate722Updated Sep 28, 2023Results posted

A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilimumab Versus Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor (TKI) Therapy

A Phase 3 interventional study of Nivolumab and Ipilimumab in Non-Small-Cell Lung Carcinoma, sponsored by Bristol-Myers Squibb. Completed at 110 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-28.

Sponsored by Bristol-Myers Squibb · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
367
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The main purpose of this study is to determine whether nivolumab + chemotherapy is effective as compared to chemotherapy in the treatment of patients with EGFR mutation, NSCLC who failed first line (1L) or second-line (2L) EGFR TKI therapy.

02

Conditions studied

  • Non-Small-Cell Lung Carcinoma
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's enrollment of 367 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Confirmed stage IV or recurrent EGFR mutated NSCLC with disease progression on one or two prior lines of treatment with EGFR TKIs (allowed TKIs must be approved by the local health authority, including but not limited to erlotinib, gefitinib, afatinib, dacomitinib and osimertinib). In osimertinib treated subjects, T790 testing is not required.
  • No evidence of exon 20 T790M mutation obtained at progression on prior first- or second-generation EGFR TKI therapy. For participants who were treated with osimertinib, T790M testing is not required.
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
  • Available tumor sample for Programmed death-ligand 1 (PD-L1) immunohistochemical (IHC).
  • Participants are eligible if central nervous system (CNS) metastases are considered to be adequately controlled/treated before or during the screening period 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 randomization. In addition, participants must be either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization). Participants with asymptomatic CNS metastasis are eligible.
  • Eastern Cooperative Group (ECOG) Performance Status 0-1
  • Life expectancy is at least 3 months

Exclusion criteria

Exclusion Criteria:

  • Known EGFR mutation, T790M positive who failed 1L first- or second-generation TKI should receive osimertinib first as the standard of care (SOC). These participants are only eligible if they fail osimertinib as 2L.
  • who have progressed within 3 months of the first dose of 1L or 2L EGFR TKI.
  • Carcinomatous meningitis
  • Active, known or suspected autoimmune disease are excluded
  • ALK translocation
  • Known SCLC transformation
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Other protocol defined inclusion/exclusion criteria apply

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
367 participants (actual)

Study arms

  • Experimental
    Nivolumab+Platinum doublet chemotherapy

    Biological: Nivolumab · Drug: Pemetrexed · Drug: Cisplatin · Drug: Carboplatin

  • Experimental
    Nivolumab + Ipilimumab

    Enrollment is closed for this arm

    Biological: Nivolumab · Biological: Ipilimumab

  • Active comparator
    Platinum doublet chemotherapy

    Drug: Pemetrexed · Drug: Cisplatin · Drug: Carboplatin

Interventions

  • BiologicalNivolumab

    Specified dose on specified days

    Also known as: Opdivo, BMS-936558

  • BiologicalIpilimumab

    Specified dose on specified days

    Also known as: Yervoy, BMS-734016

  • DrugPemetrexed

    Specified dose on specified days

  • DrugCisplatin

    Specified dose on specified days

  • DrugCarboplatin

    Specified dose on specified days

06

What researchers measure

Primary outcomes

  1. Progression Free Survival (PFS) by Blinded Independent Centralized Review (BICR)

    PFS is defined as the time between the date of randomization and the date of first documented tumor progression, as determined by BICR (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first. Participants who died without reported progression will be considered to have progressed on the date of their death. Subsequent therapy was accounted for by censoring at the last evaluable tumor assessment on or prior to the date of subsequent therapy. Progression is the appearance of one or more new lesions. RECIST - "response evaluation criteria in solid tumors" is a standard system to measure tumor response to treatment. Based on Kaplan-Meier estimates

    Time frame: From randomization to the date of first documented tumor progression or death (approximately 58 months)

Secondary outcomes

  1. Overall Survival (OS)

    Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. OS will be censored on the last date a participant was known to be alive. Median based on Kaplan-Meier Estimates

    Time frame: From randomization to the date of death due to any cause (up to approximately 67 months)

  2. Objective Response Rate (ORR) by Blinded Independent Centralized Review (BICR)

    ORR is number of randomized participants who have confirmed best overall response (BOR) of complete response (CR) or partial response (PR) using RECIST v1.1 criteria by BICR assessment. BOR is the best response designation, between randomization and objectively documented progression per RECIST v1.1 criteria by BICR or the date of subsequent anti-cancer therapy, whichever occurs first. PR is at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as reference. CR is disappearance of all target lesions and a reduction in the short axis of pathological lymph nodes to \<10 mm (whether target or non-target). Radiographic tumor response assessments from Week 7 (± 7 days), then every 6 weeks (± 7 days) until Week 49 and every 12 weeks (± 7 days) thereafter, until disease progression, treatment discontinued, or the start of subsequent anti-cancer therapy. CR+PR, confidence interval based on the Clopper and Pearson method.

    Time frame: From randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy (up to approximately 67 months)

  3. Duration of Response (DOR) by Blinded Independent Centralized Review (BICR)

    DOR is the time between the date of first response (CR or PR) and the date of first documented disease progression as determined by Response Evaluation Criteria In Solid Tumors (RECIST 1.1) or death due to any cause (death occurring after re-treatment or randomization to new combination treatment was not included), whichever occurred first. PR is at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as reference. CR is disappearance of all target lesions and a reduction in the short axis of pathological lymph nodes to \<10 mm (whether target or non-target). Radiographic tumor response assessments from Week 7 (± 7 days), then every 6 weeks (± 7 days) until Week 49 and every 12 weeks (± 7 days) thereafter, until disease progression, treatment discontinued, or the start of subsequent anti-cancer therapy. Participants who neither progress nor die were censored on the date of their last assessment. Median computed using Kaplan-Meier method

    Time frame: From randomization to the date of first documented disease progression or death due to any cause (approximately 67 months)

  4. 9 Month Progression Free Survival Rates (PFSR) by Blinded Independent Centralized Review (BICR)

    The PFSR at 9 months is defined as the percent of treated participants remaining progression free and surviving at 9 months since the first dosing date. Progression is the appearance of one or more new lesions. Point estimates are derived from Kaplan-Meier analyses.

    Time frame: 9 months after first treatment dose

  5. 12 Month Progression Free Survival Rates (PFSR) by Blinded Independent Centralized Review (BICR)

    The PFSR at 12 months is defined as the percent of treated participants remaining progression free and surviving at 12 months since the first dosing date. Progression is the appearance of one or more new lesions. Point estimates are derived from Kaplan-Meier analyses.

    Time frame: 12 Months after first treatment dose

07

Results

Posted Feb 6, 2023

Participant flow

Pre-Treatment
Participant flow — Pre-Treatment
MilestoneArm A: Nivolumab Plus Platinum-doublet ChemotherapyArm B: Nivolumab Plus IpilimumabArm C: Platinum Doublet Chemotherapy
Started14473150
Completed14171143
Not completed327
Withdrew: Adverse event unrelated to study drug100
Withdrew: Withdrawal by participant004
Withdrew: Participant no longer meets study criteria212
Withdrew: Other reasons011
Treatment
Participant flow — Treatment
MilestoneArm A: Nivolumab Plus Platinum-doublet ChemotherapyArm B: Nivolumab Plus IpilimumabArm C: Platinum Doublet Chemotherapy
Started14171143
Completed350
Not completed13866143
Withdrew: Disease progression10952101
Withdrew: Study drug toxicity9410
Withdrew: Death023
Withdrew: Adverse event unrelated to study drug116
Withdrew: Participant requested to discontinue study treatment805
Withdrew: Withdrawal by participant8513
Withdrew: Maximum clinical benefit101
Withdrew: Participant no longer meets study criteria010
Withdrew: Other reasons114
Withdrew: Administrative reason by sponsor100

Outcome measures

PrimaryProgression Free Survival (PFS) by Blinded Independent Centralized Review (BICR)

PFS is defined as the time between the date of randomization and the date of first documented tumor progression, as determined by BICR (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first. Participants who died without reported progression will be considered to have progressed on the date of their death. Subsequent therapy was accounted for by censoring at the last evaluable tumor assessment on or prior to the date of subsequent therapy. Progression is the appearance of one or more new lesions. RECIST - "response evaluation criteria in solid tumors" is a standard system to measure tumor response to treatment. Based on Kaplan-Meier estimates

Time frame:
From randomization to the date of first documented tumor progression or death (approximately 58 months)
Reported as:
Median · Months
Progression Free Survival (PFS) by Blinded Independent Centralized Review (BICR)
MonthsArm A: Nivolumab Plus Platinum-doublet ChemotherapyArm B: Nivolumab Plus IpilimumabArm C: Platinum Doublet Chemotherapy
Progression Free Survival (PFS) by Blinded Independent Centralized Review (BICR)5.59 (4.47 to 6.80)1.54 (1.41 to 2.63)5.45 (4.40 to 5.65)
Statistical analysis
  • Arm A: Nivolumab Plus Platinum-doublet Chemotherapy vs Arm C: Platinum Doublet Chemotherapy · Log Rank · p = 0.0528 (Log-rank test stratified by PD-L1 expression (\>= 1% vs \<1%/indeterminate/not evaluable), brain metastases (presence vs absence), smoking history (current/former vs never smoker), and prior osimertinib use (yes vs no) from IRT.) · Hazard ratio (hr): 0.75 · 95% CI 0.56 to 1.00Arm A over Arm C Stratified Cox proportional hazard model.
  • Arm B: Nivolumab Plus Ipilimumab vs Arm C: Platinum Doublet Chemotherapy · Hazard ratio (hr): 2.07 · 95% CI 1.43 to 2.99Arm B over Arm C Stratified Cox proportional hazard model.
SecondaryOverall Survival (OS)

Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. OS will be censored on the last date a participant was known to be alive. Median based on Kaplan-Meier Estimates

Time frame:
From randomization to the date of death due to any cause (up to approximately 67 months)
Reported as:
Median · Months
Overall Survival (OS)
MonthsArm A: Nivolumab Plus Platinum-doublet ChemotherapyArm B: Nivolumab Plus IpilimumabArm C: Platinum Doublet Chemotherapy
Overall Survival (OS)19.35 (16.13 to 20.99)17.12 (13.67 to 23.59)15.90 (14.00 to 18.79)
Statistical analysis
  • Arm A: Nivolumab Plus Platinum-doublet Chemotherapy vs Arm C: Platinum Doublet Chemotherapy · Log Rank · p = 0.2180 · Hazard ratio (hr): 0.83 · 95% CI 0.62 to 1.12Hazard Ratio (Arm A over Arm C) is based on a stratified Cox proportional hazard model
  • Arm B: Nivolumab Plus Ipilimumab vs Arm C: Platinum Doublet Chemotherapy · Hazard ratio (hr): 1.06 · 95% CI 0.75 to 1.52Hazard Ratio (Arm B over Arm C) is based on a stratified Cox proportional hazard model.
SecondaryObjective Response Rate (ORR) by Blinded Independent Centralized Review (BICR)

ORR is number of randomized participants who have confirmed best overall response (BOR) of complete response (CR) or partial response (PR) using RECIST v1.1 criteria by BICR assessment. BOR is the best response designation, between randomization and objectively documented progression per RECIST v1.1 criteria by BICR or the date of subsequent anti-cancer therapy, whichever occurs first. PR is at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as reference. CR is disappearance of all target lesions and a reduction in the short axis of pathological lymph nodes to \<10 mm (whether target or non-target). Radiographic tumor response assessments from Week 7 (± 7 days), then every 6 weeks (± 7 days) until Week 49 and every 12 weeks (± 7 days) thereafter, until disease progression, treatment discontinued, or the start of subsequent anti-cancer therapy. CR+PR, confidence interval based on the Clopper and Pearson method.

Time frame:
From randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy (up to approximately 67 months)
Reported as:
Number · Percent of Participants
Objective Response Rate (ORR) by Blinded Independent Centralized Review (BICR)
Percent of ParticipantsArm A: Nivolumab Plus Platinum-doublet ChemotherapyArm B: Nivolumab Plus IpilimumabArm C: Platinum Doublet Chemotherapy
Objective Response Rate (ORR) by Blinded Independent Centralized Review (BICR)30.6 (23.2 to 38.8)13.7 (6.8 to 23.8)26.7 (19.8 to 34.5)
Statistical analysis
  • Arm A: Nivolumab Plus Platinum-doublet Chemotherapy vs Arm C: Platinum Doublet Chemotherapy · Odds ratio (or): 1.27 · 95% CI 0.75 to 2.16Strata adjusted odds ratio (Arm A over Arm C) using Mantel-Haenszel method.
SecondaryDuration of Response (DOR) by Blinded Independent Centralized Review (BICR)

DOR is the time between the date of first response (CR or PR) and the date of first documented disease progression as determined by Response Evaluation Criteria In Solid Tumors (RECIST 1.1) or death due to any cause (death occurring after re-treatment or randomization to new combination treatment was not included), whichever occurred first. PR is at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as reference. CR is disappearance of all target lesions and a reduction in the short axis of pathological lymph nodes to \<10 mm (whether target or non-target). Radiographic tumor response assessments from Week 7 (± 7 days), then every 6 weeks (± 7 days) until Week 49 and every 12 weeks (± 7 days) thereafter, until disease progression, treatment discontinued, or the start of subsequent anti-cancer therapy. Participants who neither progress nor die were censored on the date of their last assessment. Median computed using Kaplan-Meier method

Time frame:
From randomization to the date of first documented disease progression or death due to any cause (approximately 67 months)
Reported as:
Median · Months
Duration of Response (DOR) by Blinded Independent Centralized Review (BICR)
MonthsArm A: Nivolumab Plus Platinum-doublet ChemotherapyArm B: Nivolumab Plus IpilimumabArm C: Platinum Doublet Chemotherapy
Duration of Response (DOR) by Blinded Independent Centralized Review (BICR)6.67 (4.17 to 12.45)50.04 (2.86 to NA)5.55 (4.07 to 9.92)
Secondary9 Month Progression Free Survival Rates (PFSR) by Blinded Independent Centralized Review (BICR)

The PFSR at 9 months is defined as the percent of treated participants remaining progression free and surviving at 9 months since the first dosing date. Progression is the appearance of one or more new lesions. Point estimates are derived from Kaplan-Meier analyses.

Time frame:
9 months after first treatment dose
Reported as:
Number · Percent of Participants
9 Month Progression Free Survival Rates (PFSR) by Blinded Independent Centralized Review (BICR)
Percent of ParticipantsArm A: Nivolumab Plus Platinum-doublet ChemotherapyArm B: Nivolumab Plus IpilimumabArm C: Platinum Doublet Chemotherapy
9 Month Progression Free Survival Rates (PFSR) by Blinded Independent Centralized Review (BICR)25.9 (18.4 to 34.0)12.2 (5.5 to 21.7)19.8 (12.6 to 28.1)
Secondary12 Month Progression Free Survival Rates (PFSR) by Blinded Independent Centralized Review (BICR)

The PFSR at 12 months is defined as the percent of treated participants remaining progression free and surviving at 12 months since the first dosing date. Progression is the appearance of one or more new lesions. Point estimates are derived from Kaplan-Meier analyses.

Time frame:
12 Months after first treatment dose
Reported as:
Number · Percent of Participants
12 Month Progression Free Survival Rates (PFSR) by Blinded Independent Centralized Review (BICR)
Percent of ParticipantsArm A: Nivolumab Plus Platinum-doublet ChemotherapyArm B: Nivolumab Plus IpilimumabArm C: Platinum Doublet Chemotherapy
12 Month Progression Free Survival Rates (PFSR) by Blinded Independent Centralized Review (BICR)21.2 (14.3 to 29.1)12.2 (5.5 to 21.7)15.9 (9.3 to 24.0)

Adverse events

Collected over Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm A: Nivolumab Plus Platinum-doublet Chemotherapy92/144 (63.9%)77/141 (54.6%)136/141 (96.5%)
Arm B: Nivolumab Plus Ipilimumab55/73 (75.3%)46/71 (64.8%)62/71 (87.3%)
Arm C: Platinum Doublet Chemotherapy105/150 (70%)55/143 (38.5%)140/143 (97.9%)
Most frequent serious events
Showing 10 of 132
Most frequent serious events
EventArm A: Nivolumab Plus Platinum-doublet ChemotherapyArm B: Nivolumab Plus IpilimumabArm C: Platinum Doublet Chemotherapy
Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps)25/14120/7122/143
PneumoniaInfections and infestations10/1414/717/143
DyspnoeaRespiratory, thoracic and mediastinal disorders0/1415/712/143
PneumonitisRespiratory, thoracic and mediastinal disorders5/1411/711/143
VomitingGastrointestinal disorders4/1412/711/143
Decreased appetiteMetabolism and nutrition disorders4/1410/710/143
Pericardial effusionCardiac disorders0/1412/710/143
ColitisGastrointestinal disorders1/1412/710/143
DiarrhoeaGastrointestinal disorders0/1412/710/143
PyrexiaGeneral disorders3/1412/711/143
Most frequent other events
Showing 10 of 61
Most frequent other events
EventArm A: Nivolumab Plus Platinum-doublet ChemotherapyArm B: Nivolumab Plus IpilimumabArm C: Platinum Doublet Chemotherapy
AnaemiaBlood and lymphatic system disorders66/1417/7158/143
NauseaGastrointestinal disorders63/14112/7160/143
ConstipationGastrointestinal disorders52/14121/7157/143
Decreased appetiteMetabolism and nutrition disorders42/14116/7152/143
Neutrophil count decreasedInvestigations42/1414/7145/143
White blood cell count decreasedInvestigations38/1413/7135/143
PruritusSkin and subcutaneous tissue disorders17/14118/718/143
VomitingGastrointestinal disorders35/1417/7121/143
Alanine aminotransferase increasedInvestigations35/14112/7126/143
Aspartate aminotransferase increasedInvestigations35/14111/7127/143

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Arm A: Nivolumab Plus Platinum-doublet ChemotherapyArm B: Nivolumab Plus IpilimumabArm C: Platinum Doublet ChemotherapyTotal
Mean62.3 ± 10.661.9 ± 10.660.7 ± 10.161.6 ± 10.4
Sex: Female, Male
Sex: Female, Male(Participants)Arm A: Nivolumab Plus Platinum-doublet ChemotherapyArm B: Nivolumab Plus IpilimumabArm C: Platinum Doublet ChemotherapyTotal
Female833794214
Male613656153
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Arm A: Nivolumab Plus Platinum-doublet ChemotherapyArm B: Nivolumab Plus IpilimumabArm C: Platinum Doublet ChemotherapyTotal
Hispanic or Latino0000
Not Hispanic or Latino593973171
Unknown or Not Reported853477196
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Arm A: Nivolumab Plus Platinum-doublet ChemotherapyArm B: Nivolumab Plus IpilimumabArm C: Platinum Doublet ChemotherapyTotal
American Indian or Alaska Native0000
Asian13668139343
Native Hawaiian or Other Pacific Islander0000
Black or African American0000
White731121
More than one race0000
Unknown or Not Reported1203
08

Study locations

110 sites
  • Pacific Shores Medical Group
    Long Beach, California 90808, United States
  • Local Institution - 0029
    Los Angeles, California 90017, United States
  • Local Institution - 0033
    Los Angeles, California 90095, United States
  • Local Institution - 0061
    Orange, California 92868, United States
  • Torrance Memorial Physican Network
    Redondo Beach, California 90277, United States
  • Local Institution - 0003
    New Haven, Connecticut 06520, United States
  • Local Institution - 0004
    Chicago, Illinois 60637, United States
  • Johns Hopkins University
    Baltimore, Maryland 21205, United States
  • Local Institution - 0002
    Boston, Massachusetts 02114, United States
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
  • Dana Farber Cancer Institute
    Boston, Massachusetts 02215, United States
  • Local Institution - 0064
    New York, New York 10016, United States
  • Duke University Medical Center
    Butner, North Carolina 27509-1626, United States
  • Fox Chase Cancer Center
    Philadelphia, Pennsylvania 19111, United States
  • Texas Health Physicians Group
    Arlington, Texas 76012, United States
  • Baylor Scott and White Research Institute
    Temple, Texas 76508, United States
  • Local Institution - 0063
    Tyler, Texas 75701, United States
  • Local Institution - 0001
    Salt Lake City, Utah 84112, United States
  • Local Institution - 0166
    Edmonton, Alberta T6G 1Z2, Canada
  • Local Institution - 0168
    Montreal, Quebec H4A3J1, Canada
  • Local Institution
    Beijing, Beijing 100730, China
  • Local Institution
    Beijing, Beijing 100853, China
  • Local Institution
    Chongqing, Chongqing 400042, China
  • Local Institution
    Guangzhou, Guangdong 510000, China
  • Local Institution
    Zhengzhou, Henan 450008, China
  • Local Institution
    Hong Kong, Hong Kong, China
  • Local Institution - 0043
    Changsha, Hunan 410013, China
  • Local Institution
    Changchun, Jilin 130012, China
  • Local Institution
    Changchun, Jilin 130021, China
  • Local Institution
    Xian, Shan3xi 710032, China
  • Local Institution
    Shanghai, Shanghai 200025, China
  • Local Institution
    Shanghai, Shanghai 200030, China
  • Local Institution
    Chengdu, Sichuan 610041, China
  • Local Institution - 0016
    Hangzhou, Zhejiang 310006, China
  • Local Institution - 0017
    Hangzhou, Zhejiang 310011, China
  • Local Institution
    Hangzhou, Zhejiang 310016, China
  • Local Institution
    Marseille, 13915, France
  • Local Institution - 0156
    Paris, 75005, France
  • Local Institution
    Rennes, 35033, France
  • Local Institution
    Toulouse cedex 9, 31059, France
  • Local Institution - 0027
    Hong Kong, 0, Hong Kong
  • Local Institution - 0024
    Hong Kong, Hong Kong
  • Local Institution
    Shatin, Hong Kong
  • Local Institution
    Nagoya-shi, Aichi 4648681, Japan
  • Local Institution
    Hirosaki-shi, Aomori 036-8174, Japan
  • Local Institution
    Matsuyama, Ehime 791-0280, Japan
  • Local Institution
    Iizuka, Fukuoka 8208505, Japan
  • Local Institution - 0059
    Kurume, Fukuoka 830-0011, Japan
  • Local Institution
    Fukushima-shi, Fukushima 9601295, Japan
  • Local Institution
    Koriyama, Fukushima 9630197, Japan
  • Local Institution
    Fukuyama, Hiroshima 7210971, Japan
  • Local Institution
    Hiroshima-Shi, Hiroshima 7348551, Japan
  • Local Institution - 0070
    Sapporo, Hokkaido 003-0804, Japan
  • Local Institution
    Himeji-shi, Hyogo 6708520, Japan
  • Local Institution - 0097
    Itami, Hyogo 6648540, Japan
  • Local Institution
    Kobe City, Hyogo 6500047, Japan
  • Local Institution
    Kobe, Hyogo 6500047, Japan
  • Local Institution
    Bunkyo-ku, Kanagawa 1138603, Japan
  • Local Institution - 0081
    Yokohama-shi, Kanagawa 2210855, Japan
  • Local Institution
    Yokohama, Kanagawa 236-0051, Japan
  • Local Institution
    Yokohama, Kanagawa 241-8515, Japan
  • Local Institution
    Kumamoto-shi, Kumamoto 861-4193, Japan
  • Local Institution
    Natori-shi, Miyagi 981-1293, Japan
  • Local Institution - 0077
    Sendai-shi, Miyagi 9800873, Japan
  • Local Institution
    Hirakata-shi, Osaka 573-1191, Japan
  • Local Institution
    Kishiwada shi, Osaka 5968501, Japan
  • Local Institution - 0058
    Osakasayama, Osaka 589-8511, Japan
  • Local Institution
    Sakai, Osaka 591-8555, Japan
  • Local Institution - 0076
    Hidaka, Saitama 350-1298, Japan
  • Local Institution
    Kitaadachi-gun, Saitama 362-0806, Japan
  • Local Institution - 0069
    Chuo, Tokyo 104-0045, Japan
  • Local Institution - 0078
    Koto-ku, Tokyo 1358550, Japan
  • Local Institution
    Ube Shi, Yamaguchi 7550241, Japan
  • Local Institution
    Chiba, 2608670, Japan
  • Local Institution
    Fukuoka, 810-0001, Japan
  • Local Institution
    Fukuoka, 812-8582, Japan
  • Local Institution
    Niigata, 990-9585, Japan
  • Local Institution - 0079
    Tokyo, 1600023, Japan
  • Local Institution
    Toyama, 930-8550, Japan
  • Local Institution
    Wakayama, 6418510, Japan
  • Local Institution - 0038
    Seoul, Seoul Teugbyeolsi 03722, Korea, Republic of
  • Local Institution - 0037
    Seoul, Seoul Teugbyeolsi 05505, Korea, Republic of
  • Local Institution - 0035
    Seoul, Seoul Teugbyeolsi 06351, Korea, Republic of
  • Local Institution
    Cheogju-si, 361-711, Korea, Republic of
  • Local Institution
    Gyeonggi-do,, 10408, Korea, Republic of
  • Local Institution - 0036
    Gyeonggi-do, 463-707, Korea, Republic of
  • Local Institution
    Inchoen, 405-760, Korea, Republic of
  • Local Institution
    Seoul, 06591, Korea, Republic of
  • Local Institution - 0042
    Singapore, 119074, Singapore
  • Local Institution - 0041
    Singapore, 308433, Singapore
  • Local Institution - 0158
    Barcelona, 08035, Spain
  • Local Institution
    Hospitalet de Llobregat, 08907, Spain
  • Local Institution
    Madrid, 28041, Spain
  • Local Institution
    Majadahonda, 28222, Spain
  • Local Institution
    Malaga, 29010, Spain
  • Local Institution
    Zaragoza, 50009, Spain
  • Local Institution - 0021
    Tainan, TNN 704, Taiwan
  • Local Institution - 0045
    Chiayi, 62247, Taiwan
  • Local Institution
    Kaohsiung City, 807, Taiwan
  • Local Institution
    Kaohsiung city, 82445, Taiwan

Showing the first 100 of 110 sites across 10 countries.

09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jul 30, 2020

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02864251
Lead sponsor
Bristol-Myers Squibb
Collaborators
Ono Pharmaceutical Co. Ltd
Responsible party
Sponsor
First posted
Aug 11, 2016
Start date
Mar 17, 2017
Primary completion
Jan 20, 2022
Completion
Oct 17, 2022
Results posted
Feb 6, 2023
Last update
Sep 28, 2023

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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