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Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCLC) Subjects Comparing Ipilimumab Plus Etoposide and Platinum Therapy to Etoposide and Platinum Therapy Alone

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT01450761
Collaborator
(none)
1,351
Enrollment
225
Locations
2
Arms
65.1
Actual Duration (Months)
6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to determine whether the addition of Ipilimumab to Etoposide and Platinum therapy will extend the lives of patients with Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) more than Etoposide and Platinum therapy alone.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1351 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab Plus Etoposide/Platinum Versus Etoposide/Platinum in Subjects With Newly Diagnosed Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)
Actual Study Start Date :
Dec 13, 2011
Actual Primary Completion Date :
Mar 19, 2015
Actual Study Completion Date :
May 17, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ipilimumab+Etoposide+Cisplatin/Carboplatin

Ipilimumab: IV solution, Intravenous (IV), 10 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses

Biological: Ipilimumab
Other Names:
  • Yervoy
  • BMS-734016

    • Drug: Etoposide
    Other Names:
  • Etopophos
  • Neoposid
  • Eposin

    • Drug: Cisplatin
    Other Names:
  • Platinol

    • Drug: Carboplatin
    Other Names:
  • Paraplatin

    		•
    Placebo Comparator: Placebo matching Ipilimumab+Etoposide+Cisplatin/Carboplatin

    Placebo matching Ipilimumab: IV solution, IV, 0 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses

    Biological: Placebo matching Ipilimumab

    Drug: Etoposide
    Other Names:
  • Etopophos
  • Neoposid
  • Eposin

    • Drug: Cisplatin
    Other Names:
  • Platinol

    • Drug: Carboplatin
    Other Names:
  • Paraplatin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy [Randomization until date of death, up to March 2015, approximately 38 months]

      Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.

    Secondary Outcome Measures

    1. Overall Survival in All Randomized Participants [From randomization until date of death, up to March 2015, approximately 38 months]

      Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.

    2. Progression Free Survival (PFS) Time in Participants Who Have Received at Least One Dose of Blinded Study Therapy [From randomization until disease progression, up to March 2015, approximately 38 months]

      Progression-Free Survival was defined as the time from the date of randomization to the date of progression per modified World Health Organization (mWHO) criteria or death, whichever occured first. A participant who died without reported progression per mWHO criteria was considered progressed on the date of death. For those participants who remained alive and did not progress, PFS was censored on the date of last evaluable tumor assessment. For those participants who remained alive and had no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

    Inclusion Criteria:

    • Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)

    • Eastern Cooperative Oncology Group (ECOG) of 0 or 1

    Exclusion Criteria:

    • Prior systemic therapy for lung cancer

    • Symptomatic Central Nervous System (CNS) metastases

    • History of autoimmune disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Genesis Cancer Center Hot Springs Arkansas United States 71913
    2 Sutter Medical Center Auburn California United States 95602
    3 UCSD Moores Cancer Center La Jolla California United States 92093
    4 University Of Colorado Cancer Center Aurora Colorado United States 80045
    5 Florida Cancer Specialists S. Fort Myers Florida United States 33916
    6 Cancer Specialists, LLC Jacksonville Florida United States 32256
    7 Lake City Cancer Care Lake City Florida United States 32024
    8 Florida Cancer Specialists Saint Petersburg Florida United States 33705
    9 Medical Oncology, LLC Augusta Georgia United States 30901
    10 Quincy Medical Group Quincy Illinois United States 62301
    11 Presence Medical Group Hematology Oncology Skokie Illinois United States 60077
    12 SIU School Of Medicine Springfield Illinois United States 62794-9678
    13 St. Francis Medical Group Oncology And Hematology Specialist Indianapolis Indiana United States 46237
    14 Cancer Center Of Kansas Wichita Kansas United States 67214
    15 Ashland Bellefonte Cancer Center Ashland Kentucky United States 41101
    16 University Of Kentucky Lexington Kentucky United States 40536-0093
    17 Montgomery Cancer Center Mount Sterling Kentucky United States 40353
    18 St Joseph Mercy Hospital Ypsilanti Michigan United States 48197
    19 St. Luke'S Cancer Institute Kansas City Missouri United States 64111
    20 Southeast Nebraska Hematology & Oncology Consultants, P.C. Lincoln Nebraska United States 68510
    21 Regional Cancer Care Associates, LLC/Cherry Hill Division Cherry Hill New Jersey United States 08003
    22 Memorial Sloan Kettering Nassau New York New York United States 10065
    23 Gabrail Cancer Center Canton Ohio United States 44718
    24 Oncology Hematology Care, Incorporated Cincinnati Ohio United States 45242
    25 University Hospitals Cleveland Ohio United States 44106
    26 Signal Point Clinical Research Center, Llc Middletown Ohio United States 45042
    27 Oklahoma Cancer Specialists and Research Institute, LLC Tulsa Oklahoma United States 74104
    28 Providence Portland Medical Center Portland Oregon United States 97213
    29 Kaiser Permanente Portland Oregon United States 97227
    30 Chattanooga Oncology Hematology Associates Chattanooga Tennessee United States 37404
    31 Associated in Oncology and Hematology Chattanooga Tennessee United States 37421
    32 The Jones Clinic, PC Germantown Tennessee United States 38138
    33 Tennessee Cancer Specialists Knoxville Tennessee United States 37909
    34 Thompson Cancer Survival Center Knoxville Tennessee United States 37916
    35 Tennessee Oncology, PLLC Nashville Tennessee United States 37203
    36 Henry-Joyce Cancer Center Nashville Tennessee United States 37232
    37 University Of Texas, M. D. Anderson Cancer Center Houston Texas United States 77030
    38 Joe Arrington Cancer Research And Treatment Center Lubbock Texas United States 79410
    39 Huntsman Cancer Hospital Salt Lake City Utah United States 84112
    40 Virginia Cancer Institute Richmond Virginia United States 23230
    41 Virginia Commonwealth University Richmond Virginia United States 23298
    42 Mary Babb Randolph Cancer Center Morgantown West Virginia United States 26506
    43 Local Institution Berazategui Buenos Aires Argentina B1884BBF
    44 Local Institution Buenos Aires Argentina C1280AEB
    45 Local Institution Ciudad Autonoma de Buenos Aires Argentina C1226ANZ
    46 Local Institution Provincia De Sante Fe Argentina S2000DSV
    47 Local Institution Kogarah New South Wales Australia 2217
    48 Local Institution Wollongong New South Wales Australia 2500
    49 Local Institution Chermside Queensland Australia 4032
    50 Local Institution Bedford Park South Australia Australia 5042
    51 Local Institution Fitzroy Victoria Australia 3065
    52 Local Institution Wodonga Victoria Australia 3690
    53 Local Institution Perth Western Australia Australia 6009
    54 Local Institution Linz Austria 4020
    55 Local Institution Salzburg Austria 5020
    56 Local Institution Wien Austria 1130
    57 Local Institution Wien Austria 1145
    58 Local Institution Brussels Belgium 1090
    59 Local Institution Edegem Belgium 2650
    60 Local Institution Leuven Belgium 3000
    61 Local Institution Sint Niklaas Belgium 9100
    62 Local Institution Yvoir Belgium 5530
    63 Local Institution Passo Fundo, RS Brazil 99010-260
    64 Local Institution Sao Paulo/SP Brazil CEP 01246000
    65 Local Institution SP Brazil 12245-750
    66 Local Institution Montreal Quebec Canada H2L 4M1
    67 Local Institution Montreal Quebec Canada H2W 1S6
    68 Local Institution Vina Del Mar Valparaiso Chile Region de Valparaiso, 2540364
    69 Local Institution Santiago Chile 8360160
    70 Local Institution Santiago Chile 8420383
    71 Local Institution Guangzhou Guangdong China 510060
    72 Local Institution Guangzhou Guangdong China 510080
    73 Local Institution Harbin Heilongjiang China 150084
    74 Local Institution Wuhan Hubei China 430023
    75 Local Institution Nangjing Jiangsu China 210002
    76 Local Institution Soochow Jiangsu China 215006
    77 Local Institution Changchun Jilin China 130012
    78 Local Institution Xi'an Shaanxi China 710038
    79 Local Institution Xi'an Shaanxi China 710061
    80 Local Institution Chengdu City Sichuan China 610041
    81 Local Institution Urumqi Xinjiang China 830011
    82 Local Institution Hangzhou City Zhejiang China 310009
    83 Local Institution Hangzhou City Zhejiang China
    84 Local Institution Beijing China 100032
    85 Local Institution Beijing China 100071
    86 Local Institution Beijing China 100142
    87 Local Institution Beijing China 100853
    88 Local Institution Shanghai China 200030
    89 Local Institution Shanghai China 200433
    90 Local Institution Cordoba Colombia
    91 Local Institution Ostrava - Poruba Czechia 70852
    92 Local Institution Praha 8 Czechia 180 81
    93 Local Institution Caen France 14076
    94 Local Institution Rennes Cedex 9 France 35033
    95 Local Institution Toulouse Cedex 9 France 31059
    96 Local Institution Vandoeuvre-les-nancy France 54511
    97 Local Institution Bad Berka Germany 99438
    98 Local Institution Bochum Germany 44791
    99 Local Institution Dresden Germany 01307
    100 Local Institution Erlangen Germany 91054
    101 Local Institution Frankfurt am Main Germany 60590
    102 Local Institution Gauting Germany 82131
    103 Local Institution Grosshansdorf Germany 22927
    104 Local Institution Hamburg Germany 20246
    105 Local Institution Heidelberg Germany 69126
    106 Local Institution Kassel Germany 34125
    107 Local Institution Mainz Germany 55131
    108 Local Institution Mannheim Germany 68167
    109 Local Institution Munchen Germany 81925
    110 Local Institution Oldenburg Germany 26121
    111 Local Institution Ulm Germany 89081
    112 Local Institution Hong Kong Hong Kong
    113 Local Institution Kowloon Hong Kong
    114 Local Institution Budapest Hungary 1121
    115 Local Institution Budapest Hungary 1125
    116 Local Institution Budapest Hungary H-1121
    117 Local Institution Farkasgyepu Hungary 8582
    118 Local Institution Matrahaza Hungary 3233
    119 Local Institution Pecs Hungary H-7623
    120 Local Institution Sopron Hungary 9400
    121 Local Institution Szolnok Hungary H-5000
    122 Local Institution Dublin Ireland 4
    123 Local Institution Dublin Ireland 8
    124 Local Institution Limerick Ireland
    125 Local Institution Beer Sheva Israel 84101
    126 Local Institution Kfar-saba Israel 44281
    127 Local Institution Petah-tikva Israel 49100
    128 Local Institution Ramat-gan Israel 52621
    129 Local Institution Zerifin Israel 70300
    130 Local Institution Livorno Italy 57100
    131 Local Institution Lucca Italy 55100
    132 Local Institution Meldola (FC) Italy 47014
    133 Local Institution Siena Italy 53100
    134 Local Institution Nagoya-shi Aichi Japan 4600001
    135 Local Institution Nagoya Aichi Japan 4648681
    136 Local Institution Kashiwa Chiba Japan 2778577
    137 Local Institution Matsuyama-shi Ehime Japan 7910280
    138 Local Institution Sapporo Hokkaido Japan 0608648
    139 Local Institution Kanazawa-shi Ishikawa Japan 9208641
    140 Local Institution Yokohama-Shi Kanagawa Japan 2360051
    141 Local Institution Yokohama-shi Kanagawa Japan 2408555
    142 Local Institution Natori Miyagi Japan 981-1293
    143 Local Institution Kurashiki-shi Okayama Japan 7010192
    144 Local Institution Kurashiki-shi Okayama Japan 710-8602
    145 Local Institution Hirakata-shi Osaka Japan 5731191
    146 Local Institution Takatsuki Osaka Japan 5698686
    147 Local Institution Sunto-gun Shizuoka Japan 4118777
    148 Local Institution Chuo-ku Tokyo Japan 104-0045
    149 Local Institution Ube-shi Yamaguchi Japan 7550241
    150 Local Institution Akashi, Hyogo Japan 673-8558
    151 Local Institution Fukoka Japan 811-1395
    152 Local Institution Fukuoka Japan 8128582
    153 Local Institution Osaka Japan 5898511
    154 Local Institution Oskaka Japan 5340021
    155 Local Institution Sapporo, Hokkaido Japan 0030804
    156 Local Institution Sendai, Miyagi Japan 980-0873
    157 Local Institution Tokyo Japan 135-8550
    158 Local Institution Goyang-si Gyeonggji-do Korea, Republic of 410-769
    159 Local Institution Hwasun-eup, Hwasun-gun Jeonnam Korea, Republic of 519-763
    160 Local Institution Busan Korea, Republic of 602-739
    161 Local Institution Seoul Korea, Republic of 120-752
    162 Local Institution Seoul Korea, Republic of 135-710
    163 Local Institution Seoul Korea, Republic of 136-705
    164 Local Institution Seoul Korea, Republic of 138-736
    165 Local Institution Suwon Korea, Republic of 442-723
    166 Local Institution Suwon Korea, Republic of 443-721
    167 Local Institution Guadalajara Jalisco Mexico 44280
    168 Local Institution San Luis Potosi, S.l.p. Mexico C.P. 78218
    169 Local Institution 's-Hertogenbosch Netherlands 5223 GZ
    170 Local Institution Breda Netherlands 4818 CK
    171 Local Institution Eindhoven Netherlands 5623 EJ
    172 Local Institution Cercado Peru
    173 Local Institution Lima Peru 027
    174 Local Institution Lima Peru Lima 41
    175 Local Institution Elblag Poland 82-300
    176 Local Institution Karkow Poland 31-202
    177 Local Institution Lublin Poland 20-950
    178 Local Institution Otwock Poland 05-400
    179 Local Institution Poznan Poland 60-569
    180 Local Institution Torun Poland 87-100
    181 Local Institution Warszawa Poland 02-781
    182 Local Institution Coimbra Portugal 3041853
    183 Local Institution Lisboa Portugal 1099-023
    184 Local Institution Cluj Napoca Judetul CLUJ Romania 400058
    185 Local Institution Craiova Judetul DOLJ Romania 200385
    186 Local Institution Bucuresti Romania
    187 Local Institution Cluj Romania 400015
    188 Local Institution Chelyabinsk Russian Federation 454087
    189 Local Institution Krasnodar Russian Federation 350040
    190 Local Institution Kursk Russian Federation 305035
    191 Local Institution Moscow Russian Federation 115478
    192 Local Institution Pyatigorsk Russian Federation 35702
    193 Local Institution Saint Petersburg Russian Federation 197022
    194 Local Institution Saint Petersburg Russian Federation 197758
    195 Local Institution St. Petersburg Russian Federation 194291
    196 Local Institution St. Petersburg Russian Federation 198255
    197 Local Institution Port Elizabeth Eastern CAPE South Africa 6045
    198 Local Institution Cape Town Western CAPE South Africa 7925
    199 Local Institution Pretoria South Africa 0002
    200 Local Institution A Coruna Galicia Spain 15006
    201 Local Institution Barcelona Spain 08035
    202 Local Institution Benidorm-alicante Spain 03501
    203 Local Institution Castellon Spain 12002
    204 Local Institution Lleida Spain 25198
    205 Local Institution Majadahonda Spain 28222
    206 Local Institution Malaga Spain 29010
    207 Local Institution Valencia Spain 46017
    208 Local Institution Linkoping Sweden 58185
    209 Local Institution Stockholm Sweden 17176
    210 Local Institution Uppsala Sweden 75185
    211 Local Institution Basel Switzerland 4031
    212 Local Institution Winterthur Switzerland 8401
    213 Local Institution Zuerich Switzerland 8091
    214 Local Institution Changhua City Taiwan R.O.C.
    215 Local Institution Taichung Taiwan 40705
    216 Local Institution Taipei Taiwan 100
    217 Local Institution Taoyuan County Taiwan 33305
    218 Local Institution Chiang Mai Thailand 50200
    219 Local Institution Songkhla Thailand 90110
    220 Local Institution Withington Manchester United Kingdom M20 4BX
    221 Local Institution London United Kingdom N18 1QX
    222 Local Institution London United Kingdom SW3 6JJ
    223 Local Institution Preston United Kingdom PR2 9HT
    224 Local Institution Sutton United Kingdom SM2 5PT
    225 Local Institution Truro United Kingdom TR1 3LJ

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT01450761
    Other Study ID Numbers:
    • CA184-156
    • 2011-000850-48
    First Posted:
    Oct 12, 2011
    Last Update Posted:
    Jul 8, 2020
    Last Verified:
    Jul 1, 2020
    Additional relevant MeSH terms:
    Small Cell Lung Carcinoma
    Carboplatin
    Etoposide
    Ipilimumab

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Of the 1414 enrolled participants, 566 participants each were randomized to Ipilimumab and placebo arms. The remaining 282 participants were not randomized, the most frequently reported reason being that the participants no longer met study criteria.
    Arm/Group Title Ipilimumab and Platinum/Etoposide Placebo and Platinum/Etoposide
    Arm/Group Description During the lead-in chemotherapy (induction) phase, participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles, with ipilimumab (10 mg/kg IV) every 3 weeks for cycles 3-6. During the treatment with blinded study therapy phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab. During the lead-in chemotherapy (induction) phase, participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles, with placebo every 3 weeks for cycles 3-6. During the treatment with blinded study therapy phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
    Period Title: Randomization
    STARTED 566 566
    COMPLETED 562 561
    NOT COMPLETED 4 5
    Period Title: Randomization
    STARTED 562 561
    COMPLETED 478 476
    NOT COMPLETED 84 85
    Period Title: Randomization
    STARTED 478 476
    COMPLETED 0 0
    NOT COMPLETED 478 476

    Baseline Characteristics

    Arm/Group Title Ipilimumab and Platinum/Etoposide Placebo and Platinum/Etoposide Total
    Arm/Group Description Participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab. Participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo. Total of all reporting groups
    Overall Participants 478 476 954
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    61.3
    (8.90)
    62.6
    (8.61)
    61.9
    (8.78)
    Sex: Female, Male (Count of Participants)
    Female
    161
    33.7%
    150
    31.5%
    311
    32.6%
    Male
    317
    66.3%
    326
    68.5%
    643
    67.4%

    Outcome Measures

    1. Primary Outcome
    Title Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy
    Description Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
    Time Frame Randomization until date of death, up to March 2015, approximately 38 months

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of blinded study therapy
    Arm/Group Title Ipilimumab and Platinum/Etoposide Placebo and Platinum/Etoposide
    Arm/Group Description Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab. Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
    Measure Participants 478 476
    Median (95% Confidence Interval) [months]
    10.97
    10.94
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ipilimumab and Platinum/Etoposide, Placebo and Platinum/Etoposide
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.3775
    Comments
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.936
    Confidence Interval (2-Sided) 95%
    0.807 to 1.085
    Parameter Dispersion Type:
    Value:
    Estimation Comments HR = ipilimumab over placebo
    2. Secondary Outcome
    Title Overall Survival in All Randomized Participants
    Description Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
    Time Frame From randomization until date of death, up to March 2015, approximately 38 months

    Outcome Measure Data

    Analysis Population Description
    All randomized participants
    Arm/Group Title Ipilimumab and Platinum/Etoposide Placebo and Platinum/Etoposide
    Arm/Group Description Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab. Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
    Measure Participants 566 566
    Median (95% Confidence Interval) [months]
    10.22
    9.95
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ipilimumab and Platinum/Etoposide, Placebo and Platinum/Etoposide
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.5678
    Comments
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.961
    Confidence Interval (2-Sided) 95%
    0.838 to 1.102
    Parameter Dispersion Type:
    Value:
    Estimation Comments HR = ipilimumab over placebo
    3. Secondary Outcome
    Title Progression Free Survival (PFS) Time in Participants Who Have Received at Least One Dose of Blinded Study Therapy
    Description Progression-Free Survival was defined as the time from the date of randomization to the date of progression per modified World Health Organization (mWHO) criteria or death, whichever occured first. A participant who died without reported progression per mWHO criteria was considered progressed on the date of death. For those participants who remained alive and did not progress, PFS was censored on the date of last evaluable tumor assessment. For those participants who remained alive and had no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.
    Time Frame From randomization until disease progression, up to March 2015, approximately 38 months

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of blinded study therapy
    Arm/Group Title Ipilimumab and Platinum/Etoposide Placebo and Platinum/Etoposide
    Arm/Group Description Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab. Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
    Measure Participants 478 476
    Median (95% Confidence Interval) [months]
    4.63
    4.44
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ipilimumab and Platinum/Etoposide, Placebo and Platinum/Etoposide
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0161
    Comments
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.851
    Confidence Interval (2-Sided) 95%
    0.747 to 0.971
    Parameter Dispersion Type:
    Value:
    Estimation Comments HR = ipilimumab over placebo

    Adverse Events

    Time Frame From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
    Adverse Event Reporting Description
    Arm/Group Title 10 MG/KG IPILIMUMAB + PLATINUM/ETOPOSIDE PLACEBO + PLATINUM/ETOPOSIDE
    Arm/Group Description
    All Cause Mortality
    10 MG/KG IPILIMUMAB + PLATINUM/ETOPOSIDE PLACEBO + PLATINUM/ETOPOSIDE
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    10 MG/KG IPILIMUMAB + PLATINUM/ETOPOSIDE PLACEBO + PLATINUM/ETOPOSIDE
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 316/562 (56.2%) 278/561 (49.6%)
    Blood and lymphatic system disorders
    Febrile bone marrow aplasia 0/562 (0%) 1/561 (0.2%)
    Granulocytopenia 1/562 (0.2%) 1/561 (0.2%)
    Haematotoxicity 1/562 (0.2%) 0/561 (0%)
    Leukopenia 0/562 (0%) 1/561 (0.2%)
    Eosinophilia 1/562 (0.2%) 0/561 (0%)
    Febrile neutropenia 25/562 (4.4%) 15/561 (2.7%)
    Pancytopenia 6/562 (1.1%) 7/561 (1.2%)
    Anaemia 13/562 (2.3%) 23/561 (4.1%)
    Bone marrow failure 3/562 (0.5%) 5/561 (0.9%)
    Neutropenia 15/562 (2.7%) 20/561 (3.6%)
    Thrombocytopenia 4/562 (0.7%) 8/561 (1.4%)
    Cardiac disorders
    Acute coronary syndrome 2/562 (0.4%) 0/561 (0%)
    Cardiac arrest 1/562 (0.2%) 0/561 (0%)
    Cardio-respiratory distress 1/562 (0.2%) 0/561 (0%)
    Cardiopulmonary failure 1/562 (0.2%) 3/561 (0.5%)
    Atrial fibrillation 4/562 (0.7%) 2/561 (0.4%)
    Cardiac tamponade 0/562 (0%) 2/561 (0.4%)
    Supraventricular tachycardia 1/562 (0.2%) 0/561 (0%)
    Cardiac failure 3/562 (0.5%) 3/561 (0.5%)
    Cardiogenic shock 0/562 (0%) 1/561 (0.2%)
    Myocardial infarction 3/562 (0.5%) 3/561 (0.5%)
    Arrhythmia supraventricular 0/562 (0%) 1/561 (0.2%)
    Myocardial ischaemia 0/562 (0%) 1/561 (0.2%)
    Angina pectoris 0/562 (0%) 1/561 (0.2%)
    Right ventricular failure 1/562 (0.2%) 0/561 (0%)
    Cardiac failure acute 0/562 (0%) 1/561 (0.2%)
    Cardiovascular insufficiency 0/562 (0%) 1/561 (0.2%)
    Pericardial effusion 2/562 (0.4%) 1/561 (0.2%)
    Cardiac failure congestive 0/562 (0%) 1/561 (0.2%)
    Ear and labyrinth disorders
    Vertigo 2/562 (0.4%) 0/561 (0%)
    Endocrine disorders
    Inappropriate antidiuretic hormone secretion 1/562 (0.2%) 0/561 (0%)
    Adrenal insufficiency 1/562 (0.2%) 0/561 (0%)
    Hypophysitis 4/562 (0.7%) 1/561 (0.2%)
    Autoimmune thyroiditis 1/562 (0.2%) 0/561 (0%)
    Hyperthyroidism 2/562 (0.4%) 0/561 (0%)
    Hypothyroidism 3/562 (0.5%) 0/561 (0%)
    Myxoedema 1/562 (0.2%) 0/561 (0%)
    Hypopituitarism 2/562 (0.4%) 0/561 (0%)
    Eye disorders
    Glaucoma 1/562 (0.2%) 0/561 (0%)
    Gastrointestinal disorders
    Autoimmune colitis 1/562 (0.2%) 0/561 (0%)
    Proctalgia 0/562 (0%) 1/561 (0.2%)
    Stomatitis 0/562 (0%) 1/561 (0.2%)
    Diarrhoea 42/562 (7.5%) 13/561 (2.3%)
    Diverticular perforation 0/562 (0%) 1/561 (0.2%)
    Gastrointestinal hypomotility 1/562 (0.2%) 0/561 (0%)
    Haematemesis 1/562 (0.2%) 1/561 (0.2%)
    Ileus 2/562 (0.4%) 0/561 (0%)
    Intestinal obstruction 1/562 (0.2%) 1/561 (0.2%)
    Oesophagitis 0/562 (0%) 2/561 (0.4%)
    Abdominal pain upper 0/562 (0%) 2/561 (0.4%)
    Enteritis 2/562 (0.4%) 0/561 (0%)
    Enterocolitis 2/562 (0.4%) 0/561 (0%)
    Gastric ulcer perforation 1/562 (0.2%) 0/561 (0%)
    Vomiting 10/562 (1.8%) 9/561 (1.6%)
    Nausea 12/562 (2.1%) 5/561 (0.9%)
    Odynophagia 0/562 (0%) 1/561 (0.2%)
    Pancreatitis acute 1/562 (0.2%) 0/561 (0%)
    Colitis 24/562 (4.3%) 1/561 (0.2%)
    Dysphagia 0/562 (0%) 2/561 (0.4%)
    Gastritis 1/562 (0.2%) 0/561 (0%)
    Colitis ulcerative 1/562 (0.2%) 0/561 (0%)
    Duodenal perforation 1/562 (0.2%) 0/561 (0%)
    Intestinal perforation 1/562 (0.2%) 0/561 (0%)
    Constipation 0/562 (0%) 2/561 (0.4%)
    Abdominal pain 4/562 (0.7%) 2/561 (0.4%)
    Faecaloma 0/562 (0%) 1/561 (0.2%)
    Gastrointestinal haemorrhage 1/562 (0.2%) 0/561 (0%)
    Pancreatitis 0/562 (0%) 1/561 (0.2%)
    Subileus 0/562 (0%) 1/561 (0.2%)
    General disorders
    Chest pain 5/562 (0.9%) 5/561 (0.9%)
    Condition aggravated 1/562 (0.2%) 0/561 (0%)
    Death 4/562 (0.7%) 3/561 (0.5%)
    Fatigue 4/562 (0.7%) 1/561 (0.2%)
    Sudden cardiac death 1/562 (0.2%) 0/561 (0%)
    Multi-organ failure 0/562 (0%) 6/561 (1.1%)
    Sudden death 1/562 (0.2%) 0/561 (0%)
    Euthanasia 1/562 (0.2%) 0/561 (0%)
    Disease progression 6/562 (1.1%) 9/561 (1.6%)
    Pain 1/562 (0.2%) 4/561 (0.7%)
    Asthenia 4/562 (0.7%) 5/561 (0.9%)
    Influenza like illness 0/562 (0%) 1/561 (0.2%)
    General physical health deterioration 13/562 (2.3%) 5/561 (0.9%)
    Oedema peripheral 1/562 (0.2%) 0/561 (0%)
    Pyrexia 7/562 (1.2%) 5/561 (0.9%)
    Malaise 1/562 (0.2%) 2/561 (0.4%)
    Non-cardiac chest pain 2/562 (0.4%) 0/561 (0%)
    Hepatobiliary disorders
    Hepatocellular injury 1/562 (0.2%) 0/561 (0%)
    Hepatic failure 0/562 (0%) 1/561 (0.2%)
    Hepatitis acute 1/562 (0.2%) 0/561 (0%)
    Hepatic function abnormal 1/562 (0.2%) 0/561 (0%)
    Drug-induced liver injury 4/562 (0.7%) 0/561 (0%)
    Hepatotoxicity 1/562 (0.2%) 0/561 (0%)
    Cholangitis sclerosing 1/562 (0.2%) 0/561 (0%)
    Hyperbilirubinaemia 1/562 (0.2%) 0/561 (0%)
    Cholangitis 1/562 (0.2%) 0/561 (0%)
    Cholecystitis 1/562 (0.2%) 0/561 (0%)
    Immune system disorders
    Food allergy 1/562 (0.2%) 0/561 (0%)
    Drug hypersensitivity 1/562 (0.2%) 0/561 (0%)
    Hypersensitivity 2/562 (0.4%) 1/561 (0.2%)
    Infections and infestations
    Clostridium difficile colitis 0/562 (0%) 1/561 (0.2%)
    Pyomyositis 0/562 (0%) 1/561 (0.2%)
    Encephalitis 1/562 (0.2%) 0/561 (0%)
    Gastroenteritis viral 0/562 (0%) 1/561 (0.2%)
    Rectal abscess 0/562 (0%) 1/561 (0.2%)
    Septic shock 3/562 (0.5%) 3/561 (0.5%)
    Adrenalitis 1/562 (0.2%) 0/561 (0%)
    Epididymitis 0/562 (0%) 1/561 (0.2%)
    Infection 3/562 (0.5%) 3/561 (0.5%)
    Influenza 2/562 (0.4%) 0/561 (0%)
    Appendicitis 0/562 (0%) 1/561 (0.2%)
    Infectious pleural effusion 1/562 (0.2%) 2/561 (0.4%)
    Neutropenic sepsis 0/562 (0%) 2/561 (0.4%)
    Pulmonary sepsis 0/562 (0%) 1/561 (0.2%)
    Respiratory tract infection 3/562 (0.5%) 6/561 (1.1%)
    Upper respiratory tract infection 0/562 (0%) 1/561 (0.2%)
    Bronchopneumonia 1/562 (0.2%) 1/561 (0.2%)
    Lung infection 1/562 (0.2%) 3/561 (0.5%)
    Oral candidiasis 1/562 (0.2%) 0/561 (0%)
    Pneumonia 33/562 (5.9%) 16/561 (2.9%)
    Staphylococcal infection 1/562 (0.2%) 0/561 (0%)
    Tooth abscess 0/562 (0%) 1/561 (0.2%)
    Cellulitis 0/562 (0%) 2/561 (0.4%)
    Pneumonia bacterial 1/562 (0.2%) 0/561 (0%)
    Sepsis 7/562 (1.2%) 3/561 (0.5%)
    Subcutaneous abscess 0/562 (0%) 1/561 (0.2%)
    Viral infection 1/562 (0.2%) 0/561 (0%)
    Clostridium difficile infection 1/562 (0.2%) 0/561 (0%)
    Respiratory tract infection bacterial 0/562 (0%) 1/561 (0.2%)
    Urinary tract infection 2/562 (0.4%) 5/561 (0.9%)
    Atypical pneumonia 0/562 (0%) 1/561 (0.2%)
    Bronchitis 1/562 (0.2%) 0/561 (0%)
    Device related infection 0/562 (0%) 1/561 (0.2%)
    Gastroenteritis 1/562 (0.2%) 0/561 (0%)
    Lobar pneumonia 1/562 (0.2%) 0/561 (0%)
    Lower respiratory tract infection 3/562 (0.5%) 1/561 (0.2%)
    H1n1 influenza 1/562 (0.2%) 0/561 (0%)
    Injury, poisoning and procedural complications
    Fall 0/562 (0%) 1/561 (0.2%)
    Fracture 0/562 (0%) 1/561 (0.2%)
    Rib fracture 1/562 (0.2%) 0/561 (0%)
    Vascular graft occlusion 1/562 (0.2%) 0/561 (0%)
    Hip fracture 1/562 (0.2%) 0/561 (0%)
    Overdose 2/562 (0.4%) 1/561 (0.2%)
    Subdural haematoma 1/562 (0.2%) 0/561 (0%)
    Contrast media reaction 1/562 (0.2%) 0/561 (0%)
    Femoral neck fracture 1/562 (0.2%) 1/561 (0.2%)
    Spinal compression fracture 0/562 (0%) 1/561 (0.2%)
    Toxicity to various agents 1/562 (0.2%) 0/561 (0%)
    Femur fracture 0/562 (0%) 1/561 (0.2%)
    Investigations
    General physical condition abnormal 1/562 (0.2%) 0/561 (0%)
    Neutrophil count decreased 0/562 (0%) 1/561 (0.2%)
    Weight decreased 1/562 (0.2%) 0/561 (0%)
    Blood creatinine increased 3/562 (0.5%) 1/561 (0.2%)
    Full blood count decreased 0/562 (0%) 1/561 (0.2%)
    Haemoglobin decreased 0/562 (0%) 1/561 (0.2%)
    Lipase increased 1/562 (0.2%) 0/561 (0%)
    Blood sodium decreased 0/562 (0%) 1/561 (0.2%)
    Platelet count decreased 0/562 (0%) 1/561 (0.2%)
    Metabolism and nutrition disorders
    Diabetes mellitus 0/562 (0%) 1/561 (0.2%)
    Decreased appetite 3/562 (0.5%) 0/561 (0%)
    Diabetic ketoacidosis 0/562 (0%) 1/561 (0.2%)
    Hyperglycaemia 3/562 (0.5%) 3/561 (0.5%)
    Hyponatraemia 12/562 (2.1%) 13/561 (2.3%)
    Hypoglycaemia 1/562 (0.2%) 1/561 (0.2%)
    Hypokalaemia 2/562 (0.4%) 2/561 (0.4%)
    Electrolyte imbalance 2/562 (0.4%) 1/561 (0.2%)
    Dehydration 4/562 (0.7%) 5/561 (0.9%)
    Hypocalcaemia 1/562 (0.2%) 0/561 (0%)
    Vitamin d deficiency 1/562 (0.2%) 0/561 (0%)
    Musculoskeletal and connective tissue disorders
    Flank pain 0/562 (0%) 3/561 (0.5%)
    Back pain 2/562 (0.4%) 5/561 (0.9%)
    Muscular weakness 3/562 (0.5%) 0/561 (0%)
    Rheumatoid arthritis 1/562 (0.2%) 0/561 (0%)
    Bone pain 1/562 (0.2%) 0/561 (0%)
    Spinal pain 0/562 (0%) 1/561 (0.2%)
    Joint range of motion decreased 0/562 (0%) 1/561 (0.2%)
    Musculoskeletal pain 1/562 (0.2%) 0/561 (0%)
    Groin pain 0/562 (0%) 1/561 (0.2%)
    Myositis 2/562 (0.4%) 0/561 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant neoplasm progression 36/562 (6.4%) 43/561 (7.7%)
    Neoplasm progression 0/562 (0%) 2/561 (0.4%)
    Metastatic pain 1/562 (0.2%) 0/561 (0%)
    Metastases to central nervous system 3/562 (0.5%) 8/561 (1.4%)
    Small cell lung cancer 9/562 (1.6%) 13/561 (2.3%)
    Lung cancer metastatic 1/562 (0.2%) 0/561 (0%)
    Colon cancer 0/562 (0%) 1/561 (0.2%)
    Metastatic neoplasm 1/562 (0.2%) 0/561 (0%)
    Tumour embolism 1/562 (0.2%) 0/561 (0%)
    Tumour pain 0/562 (0%) 3/561 (0.5%)
    Bone neoplasm 0/562 (0%) 1/561 (0.2%)
    Lung neoplasm malignant 1/562 (0.2%) 1/561 (0.2%)
    Metastases to meninges 3/562 (0.5%) 1/561 (0.2%)
    Tumour haemorrhage 0/562 (0%) 1/561 (0.2%)
    Nervous system disorders
    Seizure 5/562 (0.9%) 3/561 (0.5%)
    Cauda equina syndrome 0/562 (0%) 1/561 (0.2%)
    Embolic stroke 1/562 (0.2%) 0/561 (0%)
    Epilepsy 0/562 (0%) 1/561 (0.2%)
    Ischaemic stroke 0/562 (0%) 1/561 (0.2%)
    Neuralgia 0/562 (0%) 1/561 (0.2%)
    Spinal cord disorder 0/562 (0%) 1/561 (0.2%)
    Brain oedema 0/562 (0%) 1/561 (0.2%)
    Cerebral ischaemia 3/562 (0.5%) 0/561 (0%)
    Cerebral haemorrhage 0/562 (0%) 1/561 (0.2%)
    Cerebrovascular accident 1/562 (0.2%) 3/561 (0.5%)
    Depressed level of consciousness 1/562 (0.2%) 0/561 (0%)
    Monoplegia 1/562 (0.2%) 0/561 (0%)
    Spinal cord compression 2/562 (0.4%) 1/561 (0.2%)
    Toxic encephalopathy 1/562 (0.2%) 0/561 (0%)
    Vertebral artery occlusion 1/562 (0.2%) 0/561 (0%)
    Central nervous system haemorrhage 1/562 (0.2%) 0/561 (0%)
    Headache 4/562 (0.7%) 0/561 (0%)
    Ischaemic neuropathy 1/562 (0.2%) 0/561 (0%)
    Memory impairment 0/562 (0%) 1/561 (0.2%)
    Myasthenic syndrome 1/562 (0.2%) 0/561 (0%)
    Paraparesis 0/562 (0%) 1/561 (0.2%)
    Pyramidal tract syndrome 1/562 (0.2%) 0/561 (0%)
    Cerebral infarction 1/562 (0.2%) 1/561 (0.2%)
    Hepatic encephalopathy 0/562 (0%) 1/561 (0.2%)
    Presyncope 1/562 (0.2%) 0/561 (0%)
    Cognitive disorder 0/562 (0%) 1/561 (0.2%)
    Partial seizures 1/562 (0.2%) 0/561 (0%)
    Transient ischaemic attack 1/562 (0.2%) 0/561 (0%)
    Ataxia 0/562 (0%) 1/561 (0.2%)
    Dizziness 2/562 (0.4%) 2/561 (0.4%)
    Dysarthria 0/562 (0%) 1/561 (0.2%)
    Paraplegia 0/562 (0%) 1/561 (0.2%)
    Syncope 4/562 (0.7%) 1/561 (0.2%)
    Guillain-barre syndrome 1/562 (0.2%) 0/561 (0%)
    Iiird nerve disorder 1/562 (0.2%) 0/561 (0%)
    Viith nerve paralysis 1/562 (0.2%) 0/561 (0%)
    Psychiatric disorders
    Mental disorder 0/562 (0%) 1/561 (0.2%)
    Depression 0/562 (0%) 1/561 (0.2%)
    Anxiety 0/562 (0%) 1/561 (0.2%)
    Acute psychosis 1/562 (0.2%) 0/561 (0%)
    Confusional state 1/562 (0.2%) 4/561 (0.7%)
    Mental status changes 2/562 (0.4%) 2/561 (0.4%)
    Renal and urinary disorders
    Haematuria 1/562 (0.2%) 0/561 (0%)
    Tubulointerstitial nephritis 1/562 (0.2%) 0/561 (0%)
    Acute kidney injury 4/562 (0.7%) 1/561 (0.2%)
    Proteinuria 0/562 (0%) 1/561 (0.2%)
    Renal failure 1/562 (0.2%) 1/561 (0.2%)
    Reproductive system and breast disorders
    Prostatitis 0/562 (0%) 1/561 (0.2%)
    Respiratory, thoracic and mediastinal disorders
    Apnoea 1/562 (0.2%) 0/561 (0%)
    Pneumonitis 2/562 (0.4%) 4/561 (0.7%)
    Cough 1/562 (0.2%) 0/561 (0%)
    Pulmonary embolism 9/562 (1.6%) 4/561 (0.7%)
    Obstructive airways disorder 0/562 (0%) 1/561 (0.2%)
    Respiratory distress 0/562 (0%) 1/561 (0.2%)
    Acute respiratory distress syndrome 1/562 (0.2%) 0/561 (0%)
    Acute respiratory failure 1/562 (0.2%) 2/561 (0.4%)
    Dyspnoea 13/562 (2.3%) 16/561 (2.9%)
    Haemoptysis 4/562 (0.7%) 5/561 (0.9%)
    Pulmonary artery thrombosis 1/562 (0.2%) 0/561 (0%)
    Respiratory failure 9/562 (1.6%) 14/561 (2.5%)
    Chronic obstructive pulmonary disease 4/562 (0.7%) 1/561 (0.2%)
    Epistaxis 0/562 (0%) 1/561 (0.2%)
    Bronchospasm 1/562 (0.2%) 0/561 (0%)
    Hypoxia 1/562 (0.2%) 1/561 (0.2%)
    Interstitial lung disease 1/562 (0.2%) 1/561 (0.2%)
    Pneumothorax 0/562 (0%) 1/561 (0.2%)
    Hiccups 1/562 (0.2%) 0/561 (0%)
    Pleural effusion 6/562 (1.1%) 3/561 (0.5%)
    Pulmonary haemorrhage 1/562 (0.2%) 3/561 (0.5%)
    Skin and subcutaneous tissue disorders
    Rash macular 1/562 (0.2%) 0/561 (0%)
    Rash 3/562 (0.5%) 0/561 (0%)
    Pruritus 1/562 (0.2%) 0/561 (0%)
    Vascular disorders
    Hypotension 1/562 (0.2%) 1/561 (0.2%)
    Superior vena cava syndrome 0/562 (0%) 7/561 (1.2%)
    Thrombophlebitis 1/562 (0.2%) 1/561 (0.2%)
    Thrombosis 2/562 (0.4%) 1/561 (0.2%)
    Circulatory collapse 1/562 (0.2%) 2/561 (0.4%)
    Deep vein thrombosis 1/562 (0.2%) 0/561 (0%)
    Embolism 0/562 (0%) 1/561 (0.2%)
    Peripheral arterial occlusive disease 0/562 (0%) 2/561 (0.4%)
    Peripheral ischaemia 1/562 (0.2%) 0/561 (0%)
    Vascular occlusion 1/562 (0.2%) 0/561 (0%)
    Other (Not Including Serious) Adverse Events
    10 MG/KG IPILIMUMAB + PLATINUM/ETOPOSIDE PLACEBO + PLATINUM/ETOPOSIDE
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 519/562 (92.3%) 520/561 (92.7%)
    Blood and lymphatic system disorders
    Leukopenia 73/562 (13%) 87/561 (15.5%)
    Anaemia 171/562 (30.4%) 189/561 (33.7%)
    Neutropenia 234/562 (41.6%) 261/561 (46.5%)
    Thrombocytopenia 64/562 (11.4%) 84/561 (15%)
    Gastrointestinal disorders
    Diarrhoea 159/562 (28.3%) 116/561 (20.7%)
    Abdominal pain upper 30/562 (5.3%) 24/561 (4.3%)
    Vomiting 115/562 (20.5%) 97/561 (17.3%)
    Nausea 232/562 (41.3%) 209/561 (37.3%)
    Constipation 121/562 (21.5%) 99/561 (17.6%)
    Abdominal pain 34/562 (6%) 33/561 (5.9%)
    General disorders
    Chest pain 38/562 (6.8%) 45/561 (8%)
    Fatigue 180/562 (32%) 170/561 (30.3%)
    Asthenia 55/562 (9.8%) 61/561 (10.9%)
    Oedema peripheral 38/562 (6.8%) 27/561 (4.8%)
    Pyrexia 79/562 (14.1%) 60/561 (10.7%)
    Investigations
    Neutrophil count decreased 87/562 (15.5%) 67/561 (11.9%)
    Weight decreased 46/562 (8.2%) 41/561 (7.3%)
    Haemoglobin decreased 38/562 (6.8%) 32/561 (5.7%)
    Alanine aminotransferase increased 47/562 (8.4%) 26/561 (4.6%)
    Aspartate aminotransferase increased 44/562 (7.8%) 23/561 (4.1%)
    Platelet count decreased 39/562 (6.9%) 48/561 (8.6%)
    White blood cell count decreased 51/562 (9.1%) 51/561 (9.1%)
    Metabolism and nutrition disorders
    Decreased appetite 169/562 (30.1%) 138/561 (24.6%)
    Hyponatraemia 53/562 (9.4%) 50/561 (8.9%)
    Hypokalaemia 47/562 (8.4%) 31/561 (5.5%)
    Musculoskeletal and connective tissue disorders
    Back pain 43/562 (7.7%) 47/561 (8.4%)
    Arthralgia 37/562 (6.6%) 26/561 (4.6%)
    Pain in extremity 24/562 (4.3%) 36/561 (6.4%)
    Nervous system disorders
    Headache 67/562 (11.9%) 56/561 (10%)
    Dizziness 52/562 (9.3%) 59/561 (10.5%)
    Psychiatric disorders
    Insomnia 53/562 (9.4%) 62/561 (11.1%)
    Respiratory, thoracic and mediastinal disorders
    Cough 94/562 (16.7%) 81/561 (14.4%)
    Dyspnoea 75/562 (13.3%) 83/561 (14.8%)
    Hiccups 26/562 (4.6%) 32/561 (5.7%)
    Skin and subcutaneous tissue disorders
    Rash 121/562 (21.5%) 28/561 (5%)
    Alopecia 199/562 (35.4%) 208/561 (37.1%)
    Pruritus 82/562 (14.6%) 15/561 (2.7%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.

    Results Point of Contact

    Name/Title BMS Study Director
    Organization Bristol-Myers Squibb
    Phone
    Email Clinical.Trials@bms.com
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT01450761
    Other Study ID Numbers:
    • CA184-156
    • 2011-000850-48
    First Posted:
    Oct 12, 2011
    Last Update Posted:
    Jul 8, 2020
    Last Verified:
    Jul 1, 2020