ClinicalTrials.gov
History of Changes for Study: NCT02041533
An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer (CheckMate 026)
Latest version (submitted February 2, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 19, 2014 None (earliest Version on record)
2 February 28, 2014 Study Status
3 March 26, 2014 Recruitment Status, Study Status and Contacts/Locations
4 April 29, 2014 Contacts/Locations, Study Status and References
5 May 7, 2014 Contacts/Locations and Study Status
6 May 27, 2014 Contacts/Locations and Study Status
7 May 30, 2014 Study Status
8 July 4, 2014 Contacts/Locations and Study Status
9 July 9, 2014 Contacts/Locations and Study Status
10 July 23, 2014 Contacts/Locations and Study Status
11 August 11, 2014 Contacts/Locations and Study Status
12 August 28, 2014 Contacts/Locations and Study Status
13 September 15, 2014 Contacts/Locations and Study Status
14 September 22, 2014 Contacts/Locations and Study Status
15 October 13, 2014 Contacts/Locations and Study Status
16 October 30, 2014 Contacts/Locations and Study Status
17 November 13, 2014 Contacts/Locations and Study Status
18 November 20, 2014 Contacts/Locations and Study Status
19 December 5, 2014 Contacts/Locations and Study Status
20 December 31, 2014 Contacts/Locations and Study Status
21 January 27, 2015 Contacts/Locations and Study Status
22 February 26, 2015 Contacts/Locations, Study Status and Sponsor/Collaborators
23 March 5, 2015 Contacts/Locations and Study Status
24 March 23, 2015 Contacts/Locations and Study Status
25 April 13, 2015 Contacts/Locations and Study Status
26 April 20, 2015 Contacts/Locations and Study Status
27 May 6, 2015 Contacts/Locations, Study Status and Study Design
28 May 20, 2015 Study Status
29 June 3, 2015 Study Status
30 June 22, 2015 Contacts/Locations and Study Status
31 July 3, 2015 Contacts/Locations and Study Status
32 July 17, 2015 Contacts/Locations and Study Status
33 August 4, 2015 Contacts/Locations and Study Status
34 August 18, 2015 Study Status
35 September 3, 2015 Contacts/Locations and Study Status
36 September 16, 2015 Contacts/Locations and Study Status
37 October 5, 2015 Recruitment Status, Contacts/Locations and Study Status
38 October 15, 2015 Study Status
39 November 4, 2015 Contacts/Locations and Study Status
40 November 18, 2015 Study Status
41 December 8, 2015 Study Status and Contacts/Locations
42 December 21, 2015 Study Status
43 January 6, 2016 Study Status
44 January 21, 2016 Study Status
45 January 26, 2016 Study Status
46 February 10, 2016 Study Status
47 February 25, 2016 Study Status
48 March 11, 2016 Study Status
49 March 28, 2016 Study Status
50 April 12, 2016 Study Status
51 April 21, 2016 Study Status
52 April 25, 2016 Study Status
53 May 10, 2016 Study Status
54 May 25, 2016 Study Status
55 June 9, 2016 Study Status
56 June 24, 2016 Study Status
57 July 11, 2016 Study Status
58 July 26, 2016 Study Status
59 August 8, 2016 Study Status
60 August 23, 2016 Study Status
61 September 15, 2016 Study Status
62 September 23, 2016 Study Status
63 October 7, 2016 Study Status
64 October 26, 2016 Study Status
65 November 8, 2016 Study Status
66 November 30, 2016 Study Status
67 December 6, 2016 Study Status
68 December 23, 2016 Study Status
69 January 5, 2017 Study Status
70 January 23, 2017 Contacts/Locations and Study Status
71 January 27, 2017 Study Status
72 February 16, 2017 Study Status
73 March 3, 2017 Study Status
74 March 29, 2017 Study Status
75 April 17, 2017 Contacts/Locations and Study Status
76 June 26, 2017 Study Status, Outcome Measures, Contacts/Locations, References, Study Design, Oversight and Results
77 July 25, 2017 Participant Flow and Study Status
78 January 18, 2018 Contacts/Locations and Study Status
79 August 21, 2019 Contacts/Locations, Study Status, References and Outcome Measures
80 November 15, 2019 Study Status and Contacts/Locations
81 December 10, 2019 Study Status
82 January 24, 2020 Study Status and Contacts/Locations
83 May 14, 2020 Study Status and Contacts/Locations
84 June 16, 2020 Study Status
85 July 6, 2020 Contacts/Locations and Study Status
86 June 9, 2021 Contacts/Locations and Study Status
87 March 8, 2022 Contacts/Locations, Study Status, References, Eligibility and Oversight
88 May 2, 2022 Study Status and Contacts/Locations
89 July 19, 2022 Recruitment Status, Study Status and Contacts/Locations
90 February 2, 2023 Adverse Events, Outcome Measures, Participant Flow, Baseline Characteristics, Contacts/Locations, Study Status, More Information and Study Design
Comparison Format:
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Study NCT02041533
Submitted Date:  June 26, 2017 (v76)
Open or close this module Study Identification
Unique Protocol ID: CA209-026
Brief Title: An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer (CheckMate 026)
Official Title: An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer
Secondary IDs: 2012-004502-93 [EudraCT Number]
Open or close this module Study Status
Record Verification: June 2017
Overall Status: Active, not recruiting
Study Start: March 25, 2014
Primary Completion: July 1, 2016 [Actual]
Study Completion: January 1, 2018 [Anticipated]
First Submitted: January 19, 2014
First Submitted that
Met QC Criteria:		 January 19, 2014
First Posted: January 22, 2014 [Estimate]
Results First Submitted: June 26, 2017
Results First Submitted that
Met QC Criteria:		 June 26, 2017
Results First Posted: July 26, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:		 June 26, 2017
Last Update Posted: July 26, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Bristol-Myers Squibb
Responsible Party: Sponsor
Collaborators: Ono Pharmaceutical Co. Ltd
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The purpose of this study is to show that Nivolumab will improve progression free survival in subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared to chemotherapy
Detailed Description:
Open or close this module Conditions
Conditions: Stage IV or Recurrent Non-Small Cell Lung Cancer
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 1325 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Arm A: Nivolumab subjects
Nivolumab solution for Injection 3 mg/kg Intravenous every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure
 Biological: Nivolumab
Other Names:
  • BMS-936558
  • MDX-1106
Active Comparator: Arm B: Investigator's Choice Chemotherapy

Investigator's Choice Chemotherapy administered in 3-week cycles up to a maximum of 6 cycles of Intravenous injection until disease progression, unacceptable toxicity or completion of the 6 cycles, whichever comes first

Squamous subjects:

  • Gemcitabine 1250 mg/mg(2) administered on Day 1 and Day 8 with Cisplatin 75 mg/m(2) administered on Day 1 of each cycle; or
  • Gemcitabine 1000 mg/mg(2) administered on Day 1 and Day 8 with Carboplatin (AUC 5) administered on Day 1 of each cycle; or
  • Paclitaxel 200 mg/m(2) with Carboplatin (AUC 6) administered on Day 1 of each cycle

Non-Squamous subjects:

  • Pemetrexed 500 mg/m(2) with Cisplatin 75 mg/m(2) administered on Day 1 of each cycle
  • Pemetrexed 500 mg/m(2) Carboplatin (AUC 6) administered on Day 1 of each cycle

Optional crossover:

  • Nivolumab solution for Injection 3 mg/kg Intravenous every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent or study closure
 Biological: Nivolumab
Other Names:
  • BMS-936558
  • MDX-1106
Drug: Gemcitabine
Other Names:
  • Gemzar
Drug: Cisplatin
Other Names:
  • Platinol
Drug: Carboplatin
Other Names:
  • Paraplatin
Drug: Paclitaxel
Other Names:
  • Taxol
Drug: Pemetrexed
Other Names:
  • Alimta
Open or close this module Outcome Measures
[See Results Section.]
Primary Outcome Measures:
1. Progression-Free Survival in Participants With PD-L1 Expression >= 5%
[ Time Frame: From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months) ]

Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die 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 day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy.
Secondary Outcome Measures:
1. Progression-Free Survival in All Randomized Participants
[ Time Frame: From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months) ]

Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die 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 day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy.
2. Overall Survival in Participants With PD-L1 Expression >= 5%
[ Time Frame: From date of randomization to date of death (assessed up to August 2016, approximately 28 months) ]

Overall Survival (OS) was defined as the time from randomization to the date of death. A participant who had not died was censored at the last known alive date. OS was censored at the date of randomization for participants who were randomized but had no follow-up.
3. Overall Survival in All Randomized Participants
[ Time Frame: From date of randomization to date of death (assessed up to August 2016, approximately 28 months) ]

Overall Survival (OS) was defined as the time from randomization to the date of death. A participant who had not died was censored at the last known alive date. OS was censored at the date of randomization for participants who were randomized but had no follow-up.
4. Objective Response Rate (ORR) in Participants With PD-L1 Expression >= 5%
[ Time Frame: From date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to August 2016, approximately 28 months) ]

ORR was defined as the proportion of randomized participants who achieved a Best Overall Response (BOR) of CR or PR using the RECIST v1.1 criteria per Independent Radiology Review Committee (IRRC) assessment. BOR was defined as the best response designation recorded between the date of randomization and the date of objectively documented progression or start of subsequent anti-cancer therapy, whichever occurred first. For participants without documented progression or subsequent therapy, all available response designations contributed to the BOR assessment. For participants who continued treatment beyond progression, BOR was determined from response designations recorded up to the time of initial progression. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir.
5. Duration of Response in Participants With PD-L1 Expression>= 5%
[ Time Frame: From date of first confirmed response to date of tumor progression (Assessed up to August 2016, approximately 28 months) ]

Duration of Response (DOR) was summarized for participants with objective response and was defined as the time between the date of first confirmed response (CR or PR) to the date of the first documented tumor progression as determined by IRRC assessment (per RECIST v1.1) or death due to any cause, whichever occurs first. DOR censoring rules were the same as the PFS primary definition. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir
6. Time to Response in Participants With PD-L1 Expression >= 5%
[ Time Frame: From date of randomization to date of first confirmed response (assessed up to August 2016, approximately 18 months) ]

Time to Response (TTR) was defined as the time from randomization to the date of the first response (CR or PR), as assessed by IRRC assessment. TTR was evaluated for responders only. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir.
7. Disease-related Symptom Improvement Rate by Week 12
[ Time Frame: From date of randomization to week 12 ]

The Lung Cancer Symptom Score (LCSS) is a validated instrument designed to assess the impact of treatment on disease-related symptoms. It consists of 6 symptom-specific questions related to dyspnea, cough, fatigue, pain, hemoptysis and anorexia plus 3 summary items: symptom distress, interference with activity, and global HRQoL. The degree of impairment was recorded on a 100 mm visual analogue scale with scores from 0 to 100 with zero representing the best score. Disease-related symptom improvement rate by Week 12 is defined as the proportion of all randomized (all PD-L1+) participants who had 10 points or more decrease from baseline in average symptom burden index score at any time between randomization and Week 12.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1
  • Histologically confirmed Stage IV, or Recurrent NSCLC with no prior systemic anticancer therapy
  • Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per response evaluation criteria in solid tumors version (RECIST) 1.1 criteria
  • PD-L1+ on immunohistochemistry testing performed by central lab
  • Men and women, ages ≥ 18 years of age

Exclusion Criteria:

  • Known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy
  • Known anaplastic lymphoma kinase (ALK) translocations
  • Untreated central nervous system (CNS) metastases
  • Previous malignancies
  • Active, known or suspected autoimmune disease
Open or close this module Contacts/Locations
Study Officials: Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Locations: United States, Alabama
Southern Cancer Center, Inc.
Mobile, Alabama, United States, 36608
United States, Arizona
Banner Md Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope
Tucson, Arizona, United States, 85704
United States, California
Stanford Cancer Institute
Stanford, California, United States, 94305-5826
United States, Colorado
University Of Colorado Hosp
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
United States, Florida
Baptist Health Medical Group Oncology
Miami, Florida, United States, 33176
Ocala Oncology Center
Ocala, Florida, United States, 34471
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Emory University - Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Northwest Georgia Oncology Center, P.C.
Marietta, Georgia, United States, 30060
United States, Illinois
Rush University Med Ctr
Chicago, Illinois, United States, 60612
United States, Kentucky
Baptist Health Lexington
Lexington, Kentucky, United States, 40503
United States, Louisiana
Crescent City Research Consortium, LLC
Marrero, Louisiana, United States, 70072
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center.
Boston, Massachusetts, United States, 02215
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
New York University Clinical Cancer Center
New York, New York, United States, 10016
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
University Of North Carolina At Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7305
Duke University
Durham, North Carolina, United States, 27710
United States, Ohio
University Hospitals
Cleveland, Ohio, United States, 44106
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Lehigh Valley Health Network
Allentown, Pennsylvania, United States, 18103
University Of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
UPMC Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Hollings Cancer Center
Charleston, South Carolina, United States, 29425
St Francis Hospital
Greenville, South Carolina, United States, 29601
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-6307
United States, Texas
University Of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Univ Of Tx. Md Anderson
Houston, Texas, United States, 77030
Cancer Centers of South Texas
San Antonio, Texas, United States, 78212
United States, Washington
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, United States, 98902
Argentina
Clinica Colombo
Cordoba, Argentina, 5000
Instituto Oncologico De Cordoba
Cordoba, Argentina, 5000
Argentina, Buenos Aires
COIBA
Berazategui, Buenos Aires, Argentina, 1880
Instituto Medico Especializado Alexander Fleming
Capital Federal, Buenos Aires, Argentina, 1426
Hospital Italiano De Buenos Aires
Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina, 1181
Australia, New South Wales
Local Institution
Camperdown, New South Wales, Australia, 2050
Australia, Queensland
Local Institution
Brisbane, Queensland, Australia, 4102
Australia, South Australia
Local Institution
Elizabeth Vale, South Australia, Australia, 5112
Australia, Victoria
Local Institution
Fitzroy, Victoria, Australia, 3065
Local Institution
Heidelberg, Victoria, Australia, 3084
Austria
Local Institution
Wels, Austria, 4600
Local Institution
Wien, Austria, 1090
Belgium
Universitair Ziekenhuis Brussel
Brussels, Belgium, 1090
Antwerp University Hospital
Edegem, Belgium, 2650
Uz Gent
Gent, Belgium, B-9000
Uz Leuven
Leuven, Belgium, 3000
Brazil, Rio Grande Do Sul
Local Institution
Ijui, Rio Grande Do Sul, Brazil, 98700
Local Institution
Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
Brazil, Sao Paulo
Local Institution
Barretos, Sao Paulo, Brazil, 14780
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Chum-Hopital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
CISSS du Bas-Saint-Laurent Hopital Regional de Rimouski
Rimouski, Quebec, Canada, G5L 5T1
Czechia
Local Institution
Olomouc, Czechia, 779 00
Local Institution
Ostrava - Poruba, Czechia, 708 52
Local Institution
Praha 8, Czechia, 180 81
Local Institution
Usti nad Labem, Czechia, 401 13
Finland
Local Institution
Helsinki, Finland, 00029
Local Institution
Tampere, Finland, 33521
Local Institution
Vaasa, Finland, 65130
France
Local Institution
Caen, France, 14000
Local Institution
Lille, France, 59000
Local Institution
Marseille Cedex 20, France, 13915
Local Institution
Pontoise Cedex, France, 95303
Local Institution
Rennes Cedex 9, France, 35033
Local Institution
Strasbourg, France, 67090
Germany
Sozialstiftung Bamberg
Bamberg, Germany, 96049
Klinik Schillerhoehe
Gerlingen, Germany, 70839
Krankenhaus Grosshansdorf
Grosshansdorf, Germany, 22927
Thoraxklinik-Heidelberg Ggmbh
Heidelberg, Germany, 69126
Local Institution
Koeln, Germany, 50937
Local Institution
Wiesbaden, Germany, 65199
Greece
Local Institution
Athens, Greece, 11527
Greece, Creta
Local Institution
Heraklion, Creta, Greece, 71110
Hungary
Local Institution
Budapest, Hungary, 1121
Local Institution
Debrecen, Hungary, 4032
Local Institution
Matrahaza, Hungary, 3233
Italy
Azienda Ospedaliera Moscati
Avellino, Italy, 83100
Local Institution
Livorno, Italy, 57100
Local Institution
Milano, Italy, 20141
Local Institution
Napoli, Italy, 80131
Local Institution
Perugia, Italy, 06132
Local Institution
Terni, Italy, 05100
Japan
Local Institution
Akashi, Hyogo, Japan, 673-8558
Local Institution
Habikino City, Osaka, Japan, 5838588
Local Institution
Kobe, Hyogo, Japan, 6500047
Local Institution
Ota, Gunma, Japan, 3738550
Local Institution
Sapporo, Hokkaido, Japan, 062-0931
Local Institution
Tokyo, Japan, 1358550
Local Institution
Wakayama, Japan, 641-8510
Japan, Aichi
Local Institution
Nagoya, Aichi, Japan, 4648681
Local Institution
Nagoya-shi, Aichi, Japan, 4600001
Japan, Ehime
Local Institution
Matsuyama-shi, Ehime, Japan, 7910280
Japan, Miyagi
Local Institution
Natori-shi, Miyagi, Japan, 9811293
Japan, Niigata
Local Institution
Niigata-shi, Niigata, Japan, 9518566
Japan, Osaka
Local Institution
Osaka-sayama, Osaka, Japan, 589-8511
Local Institution
Osaka-shi, Osaka, Japan, 5340021
Local Institution
Sakai-shi, Osaka, Japan, 591-8555
Japan, Saitama
Local Institution
Kitaadachi-gun, Saitama, Japan, 3620806
Japan, Shizuoka
Local Institution
Sunto-gun, Shizuoka, Japan, 4118777
Japan, Tokyo
Local Institution
Chuo-ku, Tokyo, Japan, 1040045
Korea, Republic of
Local Institution
Seoul, Korea, Republic of, 120-752
Local Institution
Seoul, Korea, Republic of, 135-710
Local Institution
Seoul, Korea, Republic of
Mexico, Distrito Federal
Local Institution
Mexico City, Distrito Federal, Mexico, 14080
Mexico, Jalisco
Local Institution
Guadalajara, Jalisco, Mexico, 44280
Mexico, Yucatan
Local Institution
Merida, Yucatan, Mexico, 97133
Netherlands
Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, Netherlands, 1066 CX
Umcg, Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9713 GZ
Local Institution
Rotterdam, Netherlands, 3015 CE
Poland
Local Institution
Bydgoszcz, Poland, 85-796
Local Institution
Krakow, Poland, 31-202
Local Institution
Lodz, Poland, 93-513
Local Institution
Warszawa, Poland, 02-781
Local Institution
Wodzislaw Slaski, Poland, 44-300
Romania
Local Institution
Cluj Napoca, Romania, 400015
Local Institution
Cluj-napoca, Romania, 400352
Local Institution
Ploiesti, Romania, 100337
Spain
Local Institution
Barcelona, Spain, 08035
Local Institution
Las Palmas De Gran Canaria, Spain, 35016
Local Institution
Madrid, Spain, 28050
Local Institution
Malaga, Spain, 29010
Local Institution
Sevilla, Spain, 41013
Local Institution
Valencia, Spain, 46014
Sweden
Local Institution
Stockholm, Sweden, 171 76
Local Institution
Uppsala, Sweden, 751 85
Switzerland
Local Institution
Chur, Switzerland, 7000
Local Institution
Lausanne, Switzerland, 1011
Local Institution
Zuerich, Switzerland, 8091
Taiwan
Local Institution
Taipei, Taiwan, 11217
Turkey
Local Institution
Kayseri, Turkey, 38039
United Kingdom, Greater London
North Middlesex University Hospital
London, Greater London, United Kingdom, N18 1QX
United Kingdom, Greater Manchester
Christie Hospital Nhs Trust
Manchester, Greater Manchester, United Kingdom, M20 4XB
United Kingdom, Yorkshire
St James'S University Hospital
Leeds, Yorkshire, United Kingdom, LS9 7TF
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links: Description: BMS Clinical Trial Patient Recruiting
Available IPD/Information:
Study Results
Open or close this module Participant Flow
Recruitment Details
Pre-assignment Details 1325 participants were enrolled; 541 were randomized to a treatment group; 530 were treated. Participants were randomized but not treated due to disease progression (n=2), withdrawal of consent (n=5), or they no longer met study criteria (n=4)
 
Arm/Group Title Nivolumab Investigator Choice of Chemotherapy
Arm/Group Description Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity

Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:

Squamous:

  • gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or
  • gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or
  • paclitaxel (200 mg/m2) with carboplatin (AUC 6)

Non-Squamous:

  • pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or
  • pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total).
Period Title: Overall Study
Started 267 263
Completed 43 [1] 12 [1]
Not Completed 224 251
Reason Not Completed
Disease Progression 168 142
Study drug toxicity 27 30
Death 1 0
Adverse Event unrelated to study drug 20 21
Subject request to discontinue treatment 5 9
Withdrawal by Subject 2 1
Maximum clinical benefit 0 18
Poor/non-compliance 1 0
Other reasons 0 1
Completed max number of chemo cycles 0 29
[1]Completed = Participants continuing in the treatment period
Open or close this module Baseline Characteristics
Arm/Group TitleNivolumabInvestigator Choice of ChemotherapyTotal
Arm/Group DescriptionNivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity

Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:

Squamous:

  • gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or
  • gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or
  • paclitaxel (200 mg/m2) with carboplatin (AUC 6)

Non-Squamous:

  • pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or
  • pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total).
Total of all reporting groups
Overall Number of Baseline Participants 271 270 541
Baseline Analysis Population Description
Age, Continuous
Mean (Standard Deviation)
Unit of measure: years
Number Analyzed271 Participants270 Participants541 Participants
62.8(10.25)63.4(9.63)63.1(9.94)
Sex: Female, Male
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed271 Participants270 Participants541 Participants
Female
87
32.1%
122
45.19%
209
38.63%
Male
184
67.9%
148
54.81%
332
61.37%
Ethnicity (NIH/OMB)
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed271 Participants270 Participants541 Participants
Hispanic or Latino
4
1.48%
3
1.11%
7
1.29%
Not Hispanic or Latino
141
52.03%
139
51.48%
280
51.76%
Unknown or Not Reported
126
46.49%
128
47.41%
254
46.95%
Race (NIH/OMB)
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed271 Participants270 Participants541 Participants
American Indian or Alaska Native
1
0.37%
0
0%
1
0.18%
Asian
30
11.07%
17
6.3%
47
8.69%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
6
2.21%
10
3.7%
16
2.96%
White
228
84.13%
242
89.63%
470
86.88%
More than one race
0
0%
0
0%
0
0%
Unknown or Not Reported
6
2.21%
1
0.37%
7
1.29%
Open or close this module Outcome Measures
1. Primary Outcome:
Title Progression-Free Survival in Participants With PD-L1 Expression >= 5%
Description Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die 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 day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy.
Time Frame From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)
Outcome Measure Data
Analysis Population Description
All randomized participants with PD-L1 expression levels >= 5%
 
Arm/Group TitleNivolumabInvestigator Choice of Chemotherapy
Arm/Group DescriptionNivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity

Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:

Squamous:

  • gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or
  • gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or
  • paclitaxel (200 mg/m2) with carboplatin (AUC 6)

Non-Squamous:

  • pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or
  • pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total).
Overall Number of Participants Analyzed211 212
Median (95% Confidence Interval)
Unit of Measure: months
4.21(2.96 to 5.55) 5.88(5.42 to 6.93)
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionNivolumab, Investigator Choice of Chemotherapy
Comments[Not specified]
Type of Statistical TestSuperiority or Other
Comments[Not specified]
Statistical Test of HypothesisP-Value0.2511
Comments[Not specified]
MethodLog Rank
CommentsLog-rank test stratified by histology (squamous vs. non-squamous) as entered into the IVRS.
Method of EstimationEstimation ParameterHazard Ratio (HR)
Estimated Value1.15
Confidence Interval(2-sided) 95%
0.91 to 1.45
Estimation CommentsStratified Cox proportional hazard model. Hazard ratio of nivolumab to investigator's choice chemotherapy.
2. Secondary Outcome:
Title Progression-Free Survival in All Randomized Participants
Description Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die 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 day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy.
Time Frame From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)
Outcome Measure Data
Analysis Population Description
All randomized participants
 
Arm/Group TitleNivolumabInvestigator Choice of Chemotherapy
Arm/Group DescriptionNivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity

Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:

Squamous:

  • gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or
  • gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or
  • paclitaxel (200 mg/m2) with carboplatin (AUC 6)

Non-Squamous:

  • pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or
  • pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total).
Overall Number of Participants Analyzed271 270
Median (95% Confidence Interval)
Unit of Measure: months
4.21(3.06 to 5.52) 5.82(5.42 to 6.90)
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionNivolumab, Investigator Choice of Chemotherapy
Comments[Not specified]
Type of Statistical TestSuperiority or Other
Comments[Not specified]
Method of EstimationEstimation ParameterHazard Ratio (HR)
Estimated Value1.17
Confidence Interval(2-sided) 95%
0.95 to 1.43
Estimation CommentsStratified Cox proportional hazard model. Hazard ratio of nivolumab to investigator's choice chemotherapy.
3. Secondary Outcome:
Title Overall Survival in Participants With PD-L1 Expression >= 5%
Description Overall Survival (OS) was defined as the time from randomization to the date of death. A participant who had not died was censored at the last known alive date. OS was censored at the date of randomization for participants who were randomized but had no follow-up.
Time Frame From date of randomization to date of death (assessed up to August 2016, approximately 28 months)
Outcome Measure Data
Analysis Population Description
All randomized participants with PD-L1 expression >= 5%
 
Arm/Group TitleNivolumabInvestigator Choice of Chemotherapy
Arm/Group DescriptionNivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity

Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:

Squamous:

  • gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or
  • gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or
  • paclitaxel (200 mg/m2) with carboplatin (AUC 6)

Non-Squamous:

  • pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or
  • pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total).
Overall Number of Participants Analyzed211 212
Median (95% Confidence Interval)
Unit of Measure: months
14.36(11.66 to 17.45) 13.21(10.68 to 17.08)
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionNivolumab, Investigator Choice of Chemotherapy
Comments[Not specified]
Type of Statistical TestSuperiority or Other
Comments[Not specified]
Method of EstimationEstimation ParameterHazard Ratio (HR)
Estimated Value1.02
Confidence Interval(2-sided) 95%
0.80 to 1.30
Estimation CommentsStratified Cox proportional hazard model. Hazard ratio of nivolumab to investigator's choice chemotherapy.
4. Secondary Outcome:
Title Overall Survival in All Randomized Participants
Description Overall Survival (OS) was defined as the time from randomization to the date of death. A participant who had not died was censored at the last known alive date. OS was censored at the date of randomization for participants who were randomized but had no follow-up.
Time Frame From date of randomization to date of death (assessed up to August 2016, approximately 28 months)
Outcome Measure Data
Analysis Population Description
All randomized participants
 
Arm/Group TitleNivolumabInvestigator Choice of Chemotherapy
Arm/Group DescriptionNivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity

Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:

Squamous:

  • gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or
  • gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or
  • paclitaxel (200 mg/m2) with carboplatin (AUC 6)

Non-Squamous:

  • pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or
  • pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total).
Overall Number of Participants Analyzed271 270
Median (95% Confidence Interval)
Unit of Measure: months
13.73(11.76 to 15.41) 13.80(11.01 to 16.99)
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionNivolumab, Investigator Choice of Chemotherapy
Comments[Not specified]
Type of Statistical TestSuperiority or Other
Comments[Not specified]
Method of EstimationEstimation ParameterHazard Ratio (HR)
Estimated Value1.07
Confidence Interval(2-sided) 95%
0.86 to 1.33
Estimation CommentsStratified Cox proportional hazard model. Hazard ratio of nivolumab to investigator's choice chemotherapy.
5. Secondary Outcome:
Title Objective Response Rate (ORR) in Participants With PD-L1 Expression >= 5%
Description ORR was defined as the proportion of randomized participants who achieved a Best Overall Response (BOR) of CR or PR using the RECIST v1.1 criteria per Independent Radiology Review Committee (IRRC) assessment. BOR was defined as the best response designation recorded between the date of randomization and the date of objectively documented progression or start of subsequent anti-cancer therapy, whichever occurred first. For participants without documented progression or subsequent therapy, all available response designations contributed to the BOR assessment. For participants who continued treatment beyond progression, BOR was determined from response designations recorded up to the time of initial progression. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir.
Time Frame From date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to August 2016, approximately 28 months)
Outcome Measure Data
Analysis Population Description
All randomized participants with PD-L1 expression >= 5%
 
Arm/Group TitleNivolumabInvestigator Choice of Chemotherapy
Arm/Group DescriptionNivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity

Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:

Squamous:

  • gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or
  • gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or
  • paclitaxel (200 mg/m2) with carboplatin (AUC 6)

Non-Squamous:

  • pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or
  • pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total).
Overall Number of Participants Analyzed211 212
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
26.1(20.3 to 32.5) 33.5(27.2 to 40.3)
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionNivolumab, Investigator Choice of Chemotherapy
Comments[Not specified]
Type of Statistical TestSuperiority or Other
Comments[Not specified]
Method of EstimationEstimation ParameterOdds Ratio (OR)
Estimated Value0.70
Confidence Interval(2-sided) 95%
0.46 to 1.06
Estimation CommentsStratified by histology (squamous vs.non-squamous) at randomization. Strata adjusted odds ratio (Nivolumab over investigator choice of chemotherapy) using Mantel-Haenszel method.
6. Secondary Outcome:
Title Duration of Response in Participants With PD-L1 Expression>= 5%
Description Duration of Response (DOR) was summarized for participants with objective response and was defined as the time between the date of first confirmed response (CR or PR) to the date of the first documented tumor progression as determined by IRRC assessment (per RECIST v1.1) or death due to any cause, whichever occurs first. DOR censoring rules were the same as the PFS primary definition. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir
Time Frame From date of first confirmed response to date of tumor progression (Assessed up to August 2016, approximately 28 months)
Outcome Measure Data
Analysis Population Description
All randomized participants with a confirmed response and PD-L1 expression >= 5%
 
Arm/Group TitleNivolumabInvestigator Choice of Chemotherapy
Arm/Group DescriptionNivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity

Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:

Squamous:

  • gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or
  • gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or
  • paclitaxel (200 mg/m2) with carboplatin (AUC 6)

Non-Squamous:

  • pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or
  • pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total).
Overall Number of Participants Analyzed55 71
Median (Full Range)
Unit of Measure: months
12.12(8.84 to NA) [1] 5.65(4.21 to 8.51)
[1]NA Explanation: Upper 95% CI was not reached based on Kaplan Meier estimates.
7. Secondary Outcome:
Title Time to Response in Participants With PD-L1 Expression >= 5%
Description Time to Response (TTR) was defined as the time from randomization to the date of the first response (CR or PR), as assessed by IRRC assessment. TTR was evaluated for responders only. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir.
Time Frame From date of randomization to date of first confirmed response (assessed up to August 2016, approximately 18 months)
Outcome Measure Data
Analysis Population Description
All randomized participants with a confirmed response and PD-L1 expression >= 5%
 
Arm/Group TitleNivolumabInvestigator Choice of Chemotherapy
Arm/Group DescriptionNivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity

Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:

Squamous:

  • gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or
  • gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or
  • paclitaxel (200 mg/m2) with carboplatin (AUC 6)

Non-Squamous:

  • pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or
  • pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total).
Overall Number of Participants Analyzed55 71
Median (Full Range)
Unit of Measure: months
2.76(1.2 to 13.2) 2.56(1.2 to 9.8)
8. Secondary Outcome:
Title Disease-related Symptom Improvement Rate by Week 12
Description The Lung Cancer Symptom Score (LCSS) is a validated instrument designed to assess the impact of treatment on disease-related symptoms. It consists of 6 symptom-specific questions related to dyspnea, cough, fatigue, pain, hemoptysis and anorexia plus 3 summary items: symptom distress, interference with activity, and global HRQoL. The degree of impairment was recorded on a 100 mm visual analogue scale with scores from 0 to 100 with zero representing the best score. Disease-related symptom improvement rate by Week 12 is defined as the proportion of all randomized (all PD-L1+) participants who had 10 points or more decrease from baseline in average symptom burden index score at any time between randomization and Week 12.
Time Frame From date of randomization to week 12
Outcome Measure Data
Analysis Population Description
All randomized participants
 
Arm/Group TitleNivolumabInvestigator Choice of Chemotherapy
Arm/Group DescriptionNivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity

Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:

Squamous:

  • gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or
  • gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or
  • paclitaxel (200 mg/m2) with carboplatin (AUC 6)

Non-Squamous:

  • pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or
  • pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total).
Overall Number of Participants Analyzed271 270
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
35.4(29.7 to 41.4) 33.7(28.1 to 39.7)
Open or close this module Adverse Events
 
Time Frame From first dose to date of last dose plus 30 days (assessed up to August 2016, approximately 18 months)
Adverse Event Reporting Description [Not specified]
 
Arm/Group Title NIVOLUMAB 3 mg/kg INVESTIGATOR CHOICE
Arm/Group Description
All-Cause Mortality
  NIVOLUMAB 3 mg/kgINVESTIGATOR CHOICE
 Affected / At Risk (%)Affected / At Risk (%)
Total / /
Serious Adverse Events
  NIVOLUMAB 3 mg/kgINVESTIGATOR CHOICE
 Affected / At Risk (%)Affected / At Risk (%)
Total 155 / 267 (58.05%)115 / 263 (43.73%)
Blood and lymphatic system disorders
Anaemia † A 0 / 267 (0%)15 / 263 (5.7%)
Febrile neutropenia † A 1 / 267 (0.37%)6 / 263 (2.28%)
Leukopenia † A 0 / 267 (0%)1 / 263 (0.38%)
Neutropenia † A 0 / 267 (0%)3 / 263 (1.14%)
Pancytopenia † A 1 / 267 (0.37%)3 / 263 (1.14%)
Thrombocytopenia † A 0 / 267 (0%)6 / 263 (2.28%)
Cardiac disorders
Acute coronary syndrome † A 2 / 267 (0.75%)1 / 263 (0.38%)
Acute left ventricular failure † A 1 / 267 (0.37%)0 / 263 (0%)
Atrial fibrillation † A 0 / 267 (0%)3 / 263 (1.14%)
Atrial flutter † A 0 / 267 (0%)1 / 263 (0.38%)
Cardiac arrest † A 1 / 267 (0.37%)0 / 263 (0%)
Cardiac failure † A 0 / 267 (0%)1 / 263 (0.38%)
Cardiac failure acute † A 1 / 267 (0.37%)0 / 263 (0%)
Cardiac failure congestive † A 1 / 267 (0.37%)1 / 263 (0.38%)
Cardiac tamponade † A 1 / 267 (0.37%)0 / 263 (0%)
Myocardial infarction † A 0 / 267 (0%)2 / 263 (0.76%)
Myocardial ischaemia † A 1 / 267 (0.37%)1 / 263 (0.38%)
Pericardial effusion † A 0 / 267 (0%)1 / 263 (0.38%)
Sinus bradycardia † A 1 / 267 (0.37%)0 / 263 (0%)
Endocrine disorders
Adrenal insufficiency † A 4 / 267 (1.5%)2 / 263 (0.76%)
Eye disorders
Cataract † A 1 / 267 (0.37%)0 / 263 (0%)
Gastrointestinal disorders
Abdominal pain † A 0 / 267 (0%)2 / 263 (0.76%)
Colitis † A 3 / 267 (1.12%)0 / 263 (0%)
Constipation † A 2 / 267 (0.75%)0 / 263 (0%)
Diarrhoea † A 7 / 267 (2.62%)2 / 263 (0.76%)
Dysphagia † A 1 / 267 (0.37%)0 / 263 (0%)
Gastrointestinal haemorrhage † A 0 / 267 (0%)1 / 263 (0.38%)
Ileus † A 0 / 267 (0%)1 / 263 (0.38%)
Large intestinal obstruction † A 0 / 267 (0%)1 / 263 (0.38%)
Nausea † A 2 / 267 (0.75%)3 / 263 (1.14%)
Oesophagitis † A 1 / 267 (0.37%)0 / 263 (0%)
Small intestinal obstruction † A 0 / 267 (0%)1 / 263 (0.38%)
Upper gastrointestinal haemorrhage † A 1 / 267 (0.37%)0 / 263 (0%)
Vomiting † A 2 / 267 (0.75%)4 / 263 (1.52%)
General disorders
Asthenia † A 2 / 267 (0.75%)0 / 263 (0%)
Catheter site pain † A 0 / 267 (0%)1 / 263 (0.38%)
Chest pain † A 2 / 267 (0.75%)2 / 263 (0.76%)
Death † A 1 / 267 (0.37%)0 / 263 (0%)
Fatigue † A 2 / 267 (0.75%)5 / 263 (1.9%)
General physical health deterioration † A 3 / 267 (1.12%)3 / 263 (1.14%)
Multiple organ dysfunction syndrome † A 1 / 267 (0.37%)0 / 263 (0%)
Pain † A 1 / 267 (0.37%)1 / 263 (0.38%)
Performance status decreased † A 0 / 267 (0%)1 / 263 (0.38%)
Pyrexia † A 4 / 267 (1.5%)3 / 263 (1.14%)
Hepatobiliary disorders
Cholecystitis acute † A 2 / 267 (0.75%)0 / 263 (0%)
Cholestasis † A 1 / 267 (0.37%)1 / 263 (0.38%)
Hepatic failure † A 1 / 267 (0.37%)0 / 263 (0%)
Hepatitis † A 1 / 267 (0.37%)0 / 263 (0%)
Immune system disorders
Hypersensitivity † A 3 / 267 (1.12%)0 / 263 (0%)
Infections and infestations
Appendicitis † A 0 / 267 (0%)1 / 263 (0.38%)
Appendicitis perforated † A 0 / 267 (0%)1 / 263 (0.38%)
Bronchitis † A 1 / 267 (0.37%)2 / 263 (0.76%)
Cellulitis † A 0 / 267 (0%)1 / 263 (0.38%)
Diverticulitis † A 1 / 267 (0.37%)0 / 263 (0%)
Erysipelas † A 0 / 267 (0%)1 / 263 (0.38%)
Influenza † A 0 / 267 (0%)1 / 263 (0.38%)
Localised infection † A 0 / 267 (0%)1 / 263 (0.38%)
Lower respiratory tract infection † A 2 / 267 (0.75%)0 / 263 (0%)
Lung infection † A 6 / 267 (2.25%)0 / 263 (0%)
Peritonitis † A 0 / 267 (0%)1 / 263 (0.38%)
Pneumonia † A 10 / 267 (3.75%)17 / 263 (6.46%)
Pneumonia bacterial † A 0 / 267 (0%)1 / 263 (0.38%)
Respiratory tract infection † A 1 / 267 (0.37%)1 / 263 (0.38%)
Sepsis † A 4 / 267 (1.5%)1 / 263 (0.38%)
Septic shock † A 1 / 267 (0.37%)1 / 263 (0.38%)
Skin infection † A 0 / 267 (0%)1 / 263 (0.38%)
Subcutaneous abscess † A 1 / 267 (0.37%)0 / 263 (0%)
Upper respiratory tract infection † A 1 / 267 (0.37%)0 / 263 (0%)
Urinary tract infection † A 3 / 267 (1.12%)0 / 263 (0%)
Injury, poisoning and procedural complications
Fall † A 1 / 267 (0.37%)1 / 263 (0.38%)
Femur fracture † A 0 / 267 (0%)2 / 263 (0.76%)
Hip fracture † A 2 / 267 (0.75%)0 / 263 (0%)
Infusion related reaction † A 2 / 267 (0.75%)0 / 263 (0%)
Kyphosis postoperative † A 0 / 267 (0%)1 / 263 (0.38%)
Lumbar vertebral fracture † A 0 / 267 (0%)1 / 263 (0.38%)
Procedural complication † A 0 / 267 (0%)1 / 263 (0.38%)
Radiation necrosis † A 1 / 267 (0.37%)0 / 263 (0%)
Radiation pneumonitis † A 1 / 267 (0.37%)0 / 263 (0%)
Upper limb fracture † A 0 / 267 (0%)1 / 263 (0.38%)
Investigations
Alanine aminotransferase increased † A 5 / 267 (1.87%)0 / 263 (0%)
Aspartate aminotransferase increased † A 6 / 267 (2.25%)0 / 263 (0%)
Blood alkaline phosphatase increased † A 1 / 267 (0.37%)0 / 263 (0%)
Blood bilirubin increased † A 1 / 267 (0.37%)0 / 263 (0%)
Blood creatinine increased † A 1 / 267 (0.37%)1 / 263 (0.38%)
C-reactive protein increased † A 0 / 267 (0%)1 / 263 (0.38%)
Gamma-glutamyltransferase increased † A 2 / 267 (0.75%)0 / 263 (0%)
Haemoglobin decreased † A 0 / 267 (0%)1 / 263 (0.38%)
Transaminases increased † A 1 / 267 (0.37%)1 / 263 (0.38%)
Metabolism and nutrition disorders
Dehydration † A 4 / 267 (1.5%)2 / 263 (0.76%)
Hypercalcaemia † A 3 / 267 (1.12%)0 / 263 (0%)
Hyperglycaemia † A 2 / 267 (0.75%)0 / 263 (0%)
Hypoglycaemia † A 1 / 267 (0.37%)0 / 263 (0%)
Hypokalaemia † A 1 / 267 (0.37%)0 / 263 (0%)
Hyponatraemia † A 4 / 267 (1.5%)1 / 263 (0.38%)
Musculoskeletal and connective tissue disorders
Back pain † A 2 / 267 (0.75%)0 / 263 (0%)
Bone pain † A 1 / 267 (0.37%)2 / 263 (0.76%)
Osteolysis † A 0 / 267 (0%)1 / 263 (0.38%)
Pathological fracture † A 2 / 267 (0.75%)0 / 263 (0%)
Polyarthritis † A 1 / 267 (0.37%)0 / 263 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain † A 4 / 267 (1.5%)1 / 263 (0.38%)
Haemangioblastoma † A 1 / 267 (0.37%)0 / 263 (0%)
Lung neoplasm malignant † A 2 / 267 (0.75%)0 / 263 (0%)
Malignant melanoma † A 0 / 267 (0%)1 / 263 (0.38%)
Malignant neoplasm of spinal cord † A 1 / 267 (0.37%)0 / 263 (0%)
Malignant neoplasm progression † A 35 / 267 (13.11%)12 / 263 (4.56%)
Malignant pleural effusion † A 4 / 267 (1.5%)2 / 263 (0.76%)
Metastases to central nervous system † A 2 / 267 (0.75%)2 / 263 (0.76%)
Metastases to meninges † A 1 / 267 (0.37%)0 / 263 (0%)
Metastases to spine † A 3 / 267 (1.12%)0 / 263 (0%)
Non-small cell lung cancer † A 1 / 267 (0.37%)0 / 263 (0%)
Pericardial effusion malignant † A 5 / 267 (1.87%)1 / 263 (0.38%)
Tumour pain † A 4 / 267 (1.5%)0 / 263 (0%)
Nervous system disorders
Aphasia † A 1 / 267 (0.37%)0 / 263 (0%)
Ataxia † A 0 / 267 (0%)1 / 263 (0.38%)
Cerebrovascular accident † A 2 / 267 (0.75%)1 / 263 (0.38%)
Depressed level of consciousness † A 1 / 267 (0.37%)0 / 263 (0%)
Epilepsy † A 1 / 267 (0.37%)0 / 263 (0%)
Headache † A 1 / 267 (0.37%)0 / 263 (0%)
Loss of consciousness † A 0 / 267 (0%)1 / 263 (0.38%)
Muscle spasticity † A 1 / 267 (0.37%)0 / 263 (0%)
Presyncope † A 0 / 267 (0%)1 / 263 (0.38%)
Seizure † A 2 / 267 (0.75%)1 / 263 (0.38%)
Spinal cord compression † A 0 / 267 (0%)1 / 263 (0.38%)
Syncope † A 2 / 267 (0.75%)3 / 263 (1.14%)
Vocal cord paralysis † A 0 / 267 (0%)1 / 263 (0.38%)
Psychiatric disorders
Confusional state † A 2 / 267 (0.75%)1 / 263 (0.38%)
Mental status changes † A 1 / 267 (0.37%)0 / 263 (0%)
Psychotic disorder † A 1 / 267 (0.37%)0 / 263 (0%)
Suicide attempt † A 1 / 267 (0.37%)0 / 263 (0%)
Renal and urinary disorders
Acute kidney injury † A 1 / 267 (0.37%)0 / 263 (0%)
Haematuria † A 1 / 267 (0.37%)0 / 263 (0%)
Renal failure † A 2 / 267 (0.75%)0 / 263 (0%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure † A 0 / 267 (0%)1 / 263 (0.38%)
Atelectasis † A 1 / 267 (0.37%)0 / 263 (0%)
Bronchial obstruction † A 0 / 267 (0%)1 / 263 (0.38%)
Chronic obstructive pulmonary disease † A 3 / 267 (1.12%)6 / 263 (2.28%)
Dyspnoea † A 3 / 267 (1.12%)3 / 263 (1.14%)
Eosinophilic pneumonia † A 1 / 267 (0.37%)0 / 263 (0%)
Haemoptysis † A 0 / 267 (0%)1 / 263 (0.38%)
Haemothorax † A 0 / 267 (0%)1 / 263 (0.38%)
Interstitial lung disease † A 1 / 267 (0.37%)0 / 263 (0%)
Mediastinal disorder † A 1 / 267 (0.37%)0 / 263 (0%)
Pleural effusion † A 6 / 267 (2.25%)2 / 263 (0.76%)
Pleuritic pain † A 0 / 267 (0%)1 / 263 (0.38%)
Pneumonia aspiration † A 1 / 267 (0.37%)0 / 263 (0%)
Pneumonitis † A 7 / 267 (2.62%)0 / 263 (0%)
Pneumothorax † A 3 / 267 (1.12%)0 / 263 (0%)
Pulmonary embolism † A 5 / 267 (1.87%)5 / 263 (1.9%)
Pulmonary haemorrhage † A 2 / 267 (0.75%)1 / 263 (0.38%)
Pulmonary microemboli † A 1 / 267 (0.37%)0 / 263 (0%)
Pulmonary oedema † A 0 / 267 (0%)1 / 263 (0.38%)
Respiratory failure † A 4 / 267 (1.5%)0 / 263 (0%)
Skin and subcutaneous tissue disorders
Rash † A 1 / 267 (0.37%)0 / 263 (0%)
Rash maculo-papular † A 1 / 267 (0.37%)0 / 263 (0%)
Rash papular † A 1 / 267 (0.37%)0 / 263 (0%)
Stevens-johnson syndrome † A 1 / 267 (0.37%)0 / 263 (0%)
Vascular disorders
Air embolism † A 1 / 267 (0.37%)0 / 263 (0%)
Aortic aneurysm rupture † A 1 / 267 (0.37%)0 / 263 (0%)
Circulatory collapse † A 0 / 267 (0%)2 / 263 (0.76%)
Deep vein thrombosis † A 3 / 267 (1.12%)0 / 263 (0%)
Embolism † A 0 / 267 (0%)3 / 263 (1.14%)
Hypotension † A 1 / 267 (0.37%)0 / 263 (0%)
Iliac artery occlusion † A 0 / 267 (0%)1 / 263 (0.38%)
Jugular vein thrombosis † A 1 / 267 (0.37%)0 / 263 (0%)
Peripheral artery thrombosis † A 0 / 267 (0%)1 / 263 (0.38%)
Superior vena cava syndrome † A 0 / 267 (0%)2 / 263 (0.76%)
Vascular occlusion † A 0 / 267 (0%)1 / 263 (0.38%)
Vein disorder † A 1 / 267 (0.37%)0 / 263 (0%)
†Indicates events were collected by systematic assessment.
ATerm from vocabulary, MedDRA 19.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
  NIVOLUMAB 3 mg/kgINVESTIGATOR CHOICE
 Affected / At Risk (%)Affected / At Risk (%)
Total 238 / 267 (89.14%)248 / 263 (94.3%)
Blood and lymphatic system disorders
Anaemia † A 38 / 267 (14.23%)127 / 263 (48.29%)
Leukopenia † A 1 / 267 (0.37%)16 / 263 (6.08%)
Neutropenia † A 2 / 267 (0.75%)51 / 263 (19.39%)
Thrombocytopenia † A 4 / 267 (1.5%)38 / 263 (14.45%)
Endocrine disorders
Hypothyroidism † A 20 / 267 (7.49%)7 / 263 (2.66%)
Eye disorders
Lacrimation increased † A 3 / 267 (1.12%)21 / 263 (7.98%)
Gastrointestinal disorders
Abdominal pain † A 26 / 267 (9.74%)21 / 263 (7.98%)
Constipation † A 52 / 267 (19.48%)68 / 263 (25.86%)
Diarrhoea † A 67 / 267 (25.09%)60 / 263 (22.81%)
Dyspepsia † A 17 / 267 (6.37%)11 / 263 (4.18%)
Nausea † A 78 / 267 (29.21%)134 / 263 (50.95%)
Stomatitis † A 8 / 267 (3%)16 / 263 (6.08%)
Vomiting † A 54 / 267 (20.22%)65 / 263 (24.71%)
General disorders
Asthenia † A 21 / 267 (7.87%)37 / 263 (14.07%)
Chest pain † A 9 / 267 (3.37%)14 / 263 (5.32%)
Chills † A 16 / 267 (5.99%)12 / 263 (4.56%)
Fatigue † A 102 / 267 (38.2%)115 / 263 (43.73%)
Mucosal inflammation † A 6 / 267 (2.25%)21 / 263 (7.98%)
Non-cardiac chest pain † A 24 / 267 (8.99%)10 / 263 (3.8%)
Oedema peripheral † A 30 / 267 (11.24%)44 / 263 (16.73%)
Pyrexia † A 33 / 267 (12.36%)39 / 263 (14.83%)
Infections and infestations
Nasopharyngitis † A 17 / 267 (6.37%)12 / 263 (4.56%)
Upper respiratory tract infection † A 18 / 267 (6.74%)12 / 263 (4.56%)
Investigations
Alanine aminotransferase increased † A 25 / 267 (9.36%)18 / 263 (6.84%)
Aspartate aminotransferase increased † A 34 / 267 (12.73%)18 / 263 (6.84%)
Blood alkaline phosphatase increased † A 17 / 267 (6.37%)12 / 263 (4.56%)
Blood creatinine increased † A 10 / 267 (3.75%)18 / 263 (6.84%)
Lymphocyte count decreased † A 17 / 267 (6.37%)16 / 263 (6.08%)
Neutrophil count decreased † A 2 / 267 (0.75%)41 / 263 (15.59%)
Platelet count decreased † A 4 / 267 (1.5%)36 / 263 (13.69%)
Weight decreased † A 37 / 267 (13.86%)24 / 263 (9.13%)
White blood cell count decreased † A 4 / 267 (1.5%)29 / 263 (11.03%)
Metabolism and nutrition disorders
Decreased appetite † A 76 / 267 (28.46%)81 / 263 (30.8%)
Hyperglycaemia † A 15 / 267 (5.62%)13 / 263 (4.94%)
Hypoalbuminaemia † A 25 / 267 (9.36%)19 / 263 (7.22%)
Hypokalaemia † A 18 / 267 (6.74%)15 / 263 (5.7%)
Hypomagnesaemia † A 13 / 267 (4.87%)38 / 263 (14.45%)
Hyponatraemia † A 24 / 267 (8.99%)25 / 263 (9.51%)
Hypophosphataemia † A 7 / 267 (2.62%)14 / 263 (5.32%)
Musculoskeletal and connective tissue disorders
Arthralgia † A 35 / 267 (13.11%)17 / 263 (6.46%)
Back pain † A 34 / 267 (12.73%)33 / 263 (12.55%)
Muscular weakness † A 12 / 267 (4.49%)19 / 263 (7.22%)
Musculoskeletal chest pain † A 16 / 267 (5.99%)6 / 263 (2.28%)
Musculoskeletal pain † A 19 / 267 (7.12%)9 / 263 (3.42%)
Myalgia † A 26 / 267 (9.74%)15 / 263 (5.7%)
Pain in extremity † A 17 / 267 (6.37%)17 / 263 (6.46%)
Nervous system disorders
Dizziness † A 26 / 267 (9.74%)25 / 263 (9.51%)
Dysgeusia † A 14 / 267 (5.24%)24 / 263 (9.13%)
Headache † A 24 / 267 (8.99%)31 / 263 (11.79%)
Peripheral sensory neuropathy † A 6 / 267 (2.25%)18 / 263 (6.84%)
Psychiatric disorders
Insomnia † A 17 / 267 (6.37%)19 / 263 (7.22%)
Respiratory, thoracic and mediastinal disorders
Cough † A 67 / 267 (25.09%)49 / 263 (18.63%)
Dysphonia † A 9 / 267 (3.37%)16 / 263 (6.08%)
Dyspnoea † A 64 / 267 (23.97%)40 / 263 (15.21%)
Epistaxis † A 5 / 267 (1.87%)17 / 263 (6.46%)
Haemoptysis † A 15 / 267 (5.62%)12 / 263 (4.56%)
Productive cough † A 27 / 267 (10.11%)14 / 263 (5.32%)
Skin and subcutaneous tissue disorders
Alopecia † A 5 / 267 (1.87%)24 / 263 (9.13%)
Dry skin † A 17 / 267 (6.37%)11 / 263 (4.18%)
Pruritus † A 34 / 267 (12.73%)13 / 263 (4.94%)
Rash † A 32 / 267 (11.99%)20 / 263 (7.6%)
Rash maculo-papular † A 14 / 267 (5.24%)7 / 263 (2.66%)
†Indicates events were collected by systematic assessment.
ATerm from vocabulary, MedDRA 19.0
Open or close this module Limitations and Caveats
[Not specified]
Open or close this module More Information
Certain Agreements:
Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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/Official Title:
 Bristol-Myers Squibb Study Director
Organization:
 Bristol-Myers Squibb
Phone:
Email:
 Clinical.Trials@bms.com
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