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Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) (CheckMate 017)

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ClinicalTrials.gov Identifier: NCT01642004
Recruitment Status : Completed
First Posted : July 17, 2012
Results First Posted : March 17, 2016
Last Update Posted : December 28, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Squamous Cell Non-small Cell Lung Cancer
Interventions Biological: Nivolumab
Drug: Docetaxel
Enrollment 272
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nivolumab Docetaxel
Hide Arm/Group Description Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends. Docetaxel 75mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
Period Title: Randomization
Started [1] 135 137
Completed [2] 131 129
Not Completed 4 8
Reason Not Completed
Adverse Event unrelated to study drug             1             0
Participant withdrew consent             1             6
No longer meets study criteria             2             2
[1]
Started=Randomized
[2]
Completed= participants that received treatment
Period Title: Treatment
Started 131 129
Participants Transitioned to Nivolumab 0 6
Completed [1] 0 0
Not Completed 131 129
Reason Not Completed
Disease progression             95             79
Study drug toxicity             10             13
Death             1             1
Adverse event unrelated to study drug             9             13
Maximum clinical benefit             1             9
Poor/non-compliance             1             0
No longer meets study criteria             1             2
Other reasons             2             0
Not reported             0             3
Participant request to discontinue study treatment             6             4
Participant withdrew consent             5             5
[1]
Completed = continue in the treatment period
Arm/Group Title Nivolumab Docetaxel Total
Hide Arm/Group Description Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends. Docetaxel 75mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends. Total of all reporting groups
Overall Number of Baseline Participants 135 137 272
Hide Baseline Analysis Population Description
All randomized participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 135 participants 137 participants 272 participants
62.2  (8.33) 64.4  (8.28) 63.3  (8.36)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 135 participants 137 participants 272 participants
<= 18 years 0 0 0
< 65 years 79 73 152
>= 65 AND < 75 years 45 46 91
>= 75 AND < 85 years 10 18 28
>= 85 years 1 0 1
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 135 participants 137 participants 272 participants
Female
24
  17.8%
40
  29.2%
64
  23.5%
Male
111
  82.2%
97
  70.8%
208
  76.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 135 participants 137 participants 272 participants
Hispanic or Latino
7
   5.2%
5
   3.6%
12
   4.4%
Not Hispanic or Latino
61
  45.2%
60
  43.8%
121
  44.5%
Unknown or Not Reported
67
  49.6%
72
  52.6%
139
  51.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 135 participants 137 participants 272 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
4
   3.0%
2
   1.5%
6
   2.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
   4.4%
2
   1.5%
8
   2.9%
White
122
  90.4%
130
  94.9%
252
  92.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   2.2%
3
   2.2%
6
   2.2%
1.Primary Outcome
Title Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint
Hide Description OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method. Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm. Interim analysis (Primary Endpoint) was planned to occur after at least 196 deaths, with the actual analysis occurring at 199 deaths.
Time Frame Randomization until 199 deaths, up to November 2014, approximately 25 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Nivolumab Docetaxel
Hide Arm/Group Description:
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
Docetaxel 75mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
Overall Number of Participants Analyzed 135 137
Median (95% Confidence Interval)
Unit of Measure: months
9.23
(7.33 to 13.27)
6.01
(5.13 to 7.33)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nivolumab, Docetaxel
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments Stratified by region (US/Canada, Rest Of World (ROW), Europe) and prior treatment regimen (Paclitaxel, Another agent) as entered in the Interactive Voice Response System (IVRS).
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.59
Confidence Interval (2-Sided) 96.85%
0.43 to 0.81
Estimation Comments Stratified Cox proportional hazard model. HR = Nivolumab over Docetaxel
2.Primary Outcome
Title Overall Survival (OS) Rate in All Randomized Participants
Hide Description The overall survival rate is the probability that a participant will be alive at 6, 12, and 18 months following randomization. Overall survival was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.
Time Frame Randomization to 18 months post-randomization, up to June 2015
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Nivolumab Docetaxel
Hide Arm/Group Description:
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
Docetaxel 75mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
Overall Number of Participants Analyzed 135 137
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent probability of OS
6 months
63.7
(55.0 to 71.2)
50.7
(42.1 to 58.8)
12 months
42.2
(33.8 to 50.4)
24.3
(17.4 to 31.7)
18 months
28.1
(20.8 to 35.8)
12.5
(7.6 to 18.7)
3.Primary Outcome
Title Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint
Hide Description The number of participants who died from any cause was reported for each arm. Interim analysis (Primary Endpoint) was planned to occur after at least 196 deaths, with the actual analysis occurring at 199 deaths.
Time Frame Randomization until 199 deaths, up to November 2014, approximately 25 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Nivolumab Docetaxel
Hide Arm/Group Description:
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
Docetaxel 75mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
Overall Number of Participants Analyzed 135 137
Measure Type: Number
Unit of Measure: Participants
86 113
4.Secondary Outcome
Title Objective Response Rate (ORR) in All Randomized Participants
Hide Description ORR was defined as the percentage of all randomized participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). BOR was defined as the best investigator-assessed response designation, recorded between the date of randomization and the date of objectively documented progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or the date of subsequent anti-cancer therapy (excluding on-treatment palliative radiotherapy of non-target bone lesions or Central Nervous System (CNS) lesions), whichever occurred first. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CIs were computed using the Clopper and Pearson method.
Time Frame From the date of randomization up to the date of objectively documented progression, up to approximately 103 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Nivolumab Docetaxel
Hide Arm/Group Description:
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
Docetaxel 75mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
Overall Number of Participants Analyzed 135 137
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
20.0
(13.6 to 27.7)
8.8
(4.6 to 14.8)
5.Secondary Outcome
Title Time To Response (TTR) in Months for All Confirmed Responders
Hide Description Time to Response (TTR) for participants demonstrating a response (either CR or PR) was defined as the time from the date of randomization to the date of the first confirmed response. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters.
Time Frame From the date of randomization to the date of the first confirmed response, up to approximately 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All confirmed responders (participants demonstrating CR or PR)
Arm/Group Title Nivolumab Docetaxel
Hide Arm/Group Description:
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
Docetaxel 75mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
Overall Number of Participants Analyzed 27 12
Median (Full Range)
Unit of Measure: Months
2.23
(1.6 to 11.8)
2.09
(1.8 to 9.5)
6.Secondary Outcome
Title Duration of Objective Response (DOR) in Months for All Confirmed Responders
Hide Description DOR was defined as the time from the date of first confirmed response to the date of the first documented tumor progression (per RECIST v1.1), as determined by the investigator, or death due to any cause, whichever occurred first. DOR was evaluated only for confirmed responders (i.e. participants with confirmed CR or PR). CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. Participants who neither progressed nor died were censored on the date of their last evaluable tumor assessment.
Time Frame From the date of first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurred first, up to approximately 94 months
Hide Outcome Measure Data
Hide Analysis Population Description
All confirmed responders (participants demonstrating CR or PR)
Arm/Group Title Nivolumab Docetaxel
Hide Arm/Group Description:
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
Docetaxel 75mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
Overall Number of Participants Analyzed 27 12
Median (95% Confidence Interval)
Unit of Measure: Months
24.51
(9.76 to 69.65)
8.41
(3.58 to 14.03)
7.Secondary Outcome
Title Progression Free Survival Rate (PFSR)
Hide Description PFSR was defined as the percentage of participants who did not experience disease progression or death from any cause at a given time point following randomization. Progression was assessed by investigators according to RECIST v1.1. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who started any subsequent anti-cancer therapy (including on-treatment palliative radiation therapy (RT) of non-target bone lesions or CNS lesions) without a prior reported progression were to be censored at the last evaluable tumor assessment prior to or on initiation of the subsequent anti-cancer therapy.
Time Frame From randomization to specified timepoints, up to 84 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Nivolumab Docetaxel
Hide Arm/Group Description:
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
Docetaxel 75mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
Overall Number of Participants Analyzed 135 137
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
6 months
38.4
(30.0 to 46.8)
22.6
(15.7 to 30.2)
12 months
21.0
(14.3 to 28.6)
7.2
(3.4 to 12.8)
18 months
15.87
(9.9 to 22.8)
1.8
(0.4 to 5.7)
24 months
14.8
(9.1 to 21.8)
NA [1] 
(NA to NA)
36 months
11.0
(6.1 to 17.5)
NA [1] 
(NA to NA)
48 months
8.9
(4.5 to 15.1)
NA [1] 
(NA to NA)
60 months
8.9
(4.5 to 15.1)
NA [1] 
(NA to NA)
72 months
7.6
(3.5 to 13.7)
NA [1] 
(NA to NA)
84 months
6.1
(2.4 to 12.2)
NA [1] 
(NA to NA)
[1]
Median, lower and upper limit not reached due to insufficient number of events.
8.Secondary Outcome
Title Progression-Free Survival (PFS) Time in Months for All Randomized Participants
Hide Description PFS was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator per RECIST v1.1 criteria, or death due to any cause. Participants underwent radiographic tumor assessments every 6 weeks (+/- 5 days) from week 9 (+/- 5 days) for the first year on treatment, then every 12 weeks after the first year on treatment until documented disease progression. The PFS curves were estimated using KM method. Two-sided 95% CI for median PFS were computed by Brookmeyer and Crowley method (using log-log transformation). Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who started any subsequent anti-cancer therapy (including on-treatment palliative RT of non-target bone lesions or CNS lesions) without a prior reported progression were to be censored at the last evaluable tumor assessment prior to or on initiation of the subsequent anti-cancer therapy.
Time Frame From randomization up to the first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurred first, up to approximately 103 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Nivolumab Docetaxel
Hide Arm/Group Description:
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
Docetaxel 75mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
Overall Number of Participants Analyzed 135 137
Median (95% Confidence Interval)
Unit of Measure: Months
3.48
(2.14 to 5.06)
2.83
(2.10 to 3.52)
9.Secondary Outcome
Title Percentage of Participants Experiencing Disease-related Symptom Improvement by Week 12
Hide Description Disease-related symptom improvement rate by Week 12 was defined as the percentage of randomized participants who had a 10 point or greater decrease from baseline in average symptom burden index score at any time between randomization and Week 12. The participant portion of the Lung Cancer Symptom Scale (LCSS) consisted of 6 symptom-specific questions that addressed cough, dyspnea, fatigue, pain, hemoptysis, and anorexia, plus 3 summary items on symptom distress, interference with activity level, and global health-related Quality of Life (QoL). The scores range from 0 to 100, with 0 representing the best possible score and 100 being the worst possible score. The average symptom burden index score at each assessment was defined as the mean of the 6 symptom-specific questions of the LCSS. 95% CIs were computed using Clopper-Pearson Method.
Time Frame From randomization up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Nivolumab Docetaxel
Hide Arm/Group Description:
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
Docetaxel 75mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
Overall Number of Participants Analyzed 135 137
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
18.5
(12.4 to 26.1)
21.2
(14.7 to 29.0)
10.Secondary Outcome
Title Overall Survival (OS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants
Hide Description OS was measured in months for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method.
Time Frame From the date of randomization to the date of death from any cause, up to approximately 103 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Nivolumab Docetaxel
Hide Arm/Group Description:
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
Docetaxel 75mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
Overall Number of Participants Analyzed 135 137
Median (95% Confidence Interval)
Unit of Measure: Months
PD-L1 expression >= 5% Number Analyzed 42 participants 39 participants
9.95
(5.82 to 16.69)
6.37
(4.50 to 9.03)
PD-L1 expression < 5% Number Analyzed 75 participants 69 participants
8.54
(5.49 to 12.62)
6.14
(5.13 to 8.28)
PD-L1 not quantifiable at baseline Number Analyzed 18 participants 29 participants
9.41
(7.10 to 25.20)
5.06
(3.02 to 6.11)
11.Secondary Outcome
Title Objective Response Rate (ORR) by Baseline PD-L1 Expression for All Randomized Participants
Hide Description ORR was reported for all randomized participants grouped by their baseline PD-L1 expression level. ORR was defined as the percentage of all randomized participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CIs were computed using the Clopper and Pearson method.
Time Frame From the date of randomization up to the date of objectively documented progression, up to approximately 103 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Nivolumab Docetaxel
Hide Arm/Group Description:
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
Docetaxel 75mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
Overall Number of Participants Analyzed 135 137
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
PD-L1 expression >= 5% Number Analyzed 42 participants 39 participants
21.4
(10.3 to 36.8)
7.7
(1.6 to 20.9)
PD-L1 expression < 5% Number Analyzed 75 participants 69 participants
14.7
(7.6 to 24.7)
11.6
(5.1 to 21.6)
PD-L1 not quantifiable at baseline Number Analyzed 18 participants 29 participants
38.9
(17.3 to 64.3)
3.4
(0.1 to 17.8)
12.Secondary Outcome
Title Progression Free Survival (PFS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants
Hide Description PFS time was measured for all randomized participants grouped by their baseline PD-L1 expression levels. PFS was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator per RECIST v1.1 criteria, or death due to any cause. The PFS curves were estimated using KM method. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who started subsequent anti-cancer therapy (including on-treatment palliative radiotherapy of non-target bone lesions or CNS lesions) without a prior reported progression were censored at the last evaluable tumor assessment prior to subsequent anti-cancer therapy.
Time Frame From the date of first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurred first, up to approximately 103 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Nivolumab Docetaxel
Hide Arm/Group Description:
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
Docetaxel 75mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
Overall Number of Participants Analyzed 135 137
Median (95% Confidence Interval)
Unit of Measure: Months
PD-L1 expression >= 5% Number Analyzed 42 participants 39 participants
5.06
(2.10 to 7.56)
3.06
(1.94 to 4.63)
PD-L1 expression < 5% Number Analyzed 75 participants 69 participants
2.23
(1.94 to 4.73)
2.92
(2.07 to 3.58)
PD-L1 not quantifiable at baseline Number Analyzed 18 participants 29 participants
5.39
(2.10 to 10.45)
2.23
(2.04 to 4.40)
13.Post-Hoc Outcome
Title Overall Survival (OS) Time in Months for All Randomized Participants - Extended Collection
Hide Description OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method. Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm. Survival follow-up analysis occurred at the end of the study.
Time Frame From the date of first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurred first, up to approximately 103 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Nivolumab Docetaxel
Hide Arm/Group Description:
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
Docetaxel 75mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
Overall Number of Participants Analyzed 135 137
Median (95% Confidence Interval)
Unit of Measure: Months
9.23
(7.33 to 12.62)
6.01
(5.13 to 7.33)
14.Post-Hoc Outcome
Title Overall Survival (OS) Rate in All Randomized Participants - Extended Collection
Hide Description The overall survival rate is the probability that a participant will be alive at the specified timepoints following randomization. Overall survival was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.
Time Frame From the date of randomization up to the specified timepoints, up to 84 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Nivolumab Docetaxel
Hide Arm/Group Description:
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
Docetaxel 75mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
Overall Number of Participants Analyzed 135 137
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent probability of OS
6 months
63.7
(55.0 to 71.2)
50.4
(41.7 to 58.4)
12 months
42.2
(33.8 to 50.4)
24.1
(17.3 to 31.5)
18 months
28.1
(20.8 to 35.9)
12.4
(7.6 to 18.5)
24 months
23.0
(16.3 to 30.3)
8.0
(4.3 to 13.3)
36 months
15.6
(10.0 to 22.2)
5.8
(2.7 to 10.6)
48 months
13.1
(8.1 to 19.5)
4.4
(1.8 to 8.8)
60 months
12.3
(7.4 to 18.5)
3.6
(1.4 to 7.8)
72 months
11.4
(6.7 to 17.5)
2.7
(0.8 to 6.7)
84 months
9.6
(5.3 to 15.5)
0.0 [1] 
(NA to NA)
[1]
Lower and upper limit not calculated due to insufficient number of events.
Time Frame Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
Adverse Event Reporting Description

All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants.

ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
 
Arm/Group Title Nivolumab 3 mg/kg Nivolumab 480 mg Docetaxel Extension Phase of Docetaxel Arm: Nivolumab 3 mg/kg Extension Phase of Docetaxel Arm: Nivolumab 480 mg
Hide Arm/Group Description Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Nivolumab 480 mg solution intravenously every 4 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Docetaxel 75mg/m^2 solution intravenously every 3 weeks until documented disease progression , discontinuation due to toxicity, withdrawal of consent or study ends. Eligible patients from the Docetaxel arm may receive nivolumab 3 mg/kg every 2 weeks via extension phase until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends. Eligible patients from the Docetaxel arm may receive nivolumab 480 mg flat dose every 4 weeks via extension phase until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
All-Cause Mortality
Nivolumab 3 mg/kg Nivolumab 480 mg Docetaxel Extension Phase of Docetaxel Arm: Nivolumab 3 mg/kg Extension Phase of Docetaxel Arm: Nivolumab 480 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   119/135 (88.15%)   2/6 (33.33%)   129/137 (94.16%)   5/6 (83.33%)   1/1 (100.00%) 
Hide Serious Adverse Events
Nivolumab 3 mg/kg Nivolumab 480 mg Docetaxel Extension Phase of Docetaxel Arm: Nivolumab 3 mg/kg Extension Phase of Docetaxel Arm: Nivolumab 480 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   85/131 (64.89%)   1/6 (16.67%)   92/129 (71.32%)   4/6 (66.67%)   0/1 (0.00%) 
Blood and lymphatic system disorders           
Anaemia † 1  2/131 (1.53%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Febrile bone marrow aplasia † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Febrile neutropenia † 1  0/131 (0.00%)  0/6 (0.00%)  13/129 (10.08%)  0/6 (0.00%)  0/1 (0.00%) 
Myelosuppression † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Neutropenia † 1  1/131 (0.76%)  0/6 (0.00%)  3/129 (2.33%)  0/6 (0.00%)  0/1 (0.00%) 
Pancytopenia † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Thrombocytopenia † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Cardiac disorders           
Atrial fibrillation † 1  0/131 (0.00%)  0/6 (0.00%)  4/129 (3.10%)  0/6 (0.00%)  0/1 (0.00%) 
Atrial flutter † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Atrial thrombosis † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Cardiac failure † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Cardiac tamponade † 1  1/131 (0.76%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Cardio-respiratory arrest † 1  2/131 (1.53%)  0/6 (0.00%)  2/129 (1.55%)  0/6 (0.00%)  0/1 (0.00%) 
Myocardial infarction † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Pericardial effusion † 1  1/131 (0.76%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Sinus bradycardia † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Endocrine disorders           
Adrenal insufficiency † 1  0/131 (0.00%)  0/6 (0.00%)  0/129 (0.00%)  1/6 (16.67%)  0/1 (0.00%) 
Goitre † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Hypothyroidism † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Gastrointestinal disorders           
Abdominal pain † 1  0/131 (0.00%)  0/6 (0.00%)  3/129 (2.33%)  0/6 (0.00%)  0/1 (0.00%) 
Constipation † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Diarrhoea † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Dysphagia † 1  3/131 (2.29%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Intestinal perforation † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Nausea † 1  1/131 (0.76%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Oesophagitis † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Oesophagitis ulcerative † 1  0/131 (0.00%)  0/6 (0.00%)  0/129 (0.00%)  1/6 (16.67%)  0/1 (0.00%) 
Pancreatitis † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Pneumoperitoneum † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Vomiting † 1  0/131 (0.00%)  0/6 (0.00%)  2/129 (1.55%)  1/6 (16.67%)  0/1 (0.00%) 
General disorders           
Asthenia † 1  0/131 (0.00%)  0/6 (0.00%)  2/129 (1.55%)  0/6 (0.00%)  0/1 (0.00%) 
Chills † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Fatigue † 1  1/131 (0.76%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
General physical health deterioration † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  1/6 (16.67%)  0/1 (0.00%) 
Multiple organ dysfunction syndrome † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Oedema peripheral † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Pain † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Pyrexia † 1  5/131 (3.82%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Sudden death † 1  1/131 (0.76%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Swelling † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Hepatobiliary disorders           
Immune-mediated hepatitis † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Infections and infestations           
Bacterial infection † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Bronchitis † 1  2/131 (1.53%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Clostridium difficile colitis † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Enterocolitis infectious † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Infection † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Lower respiratory tract infection † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Neutropenic infection † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Pneumocystis jirovecii pneumonia † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Pneumonia † 1  14/131 (10.69%)  1/6 (16.67%)  17/129 (13.18%)  2/6 (33.33%)  0/1 (0.00%) 
Respiratory tract infection † 1  1/131 (0.76%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Sepsis † 1  1/131 (0.76%)  0/6 (0.00%)  3/129 (2.33%)  1/6 (16.67%)  0/1 (0.00%) 
Septic shock † 1  1/131 (0.76%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Skin infection † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Upper respiratory tract infection † 1  2/131 (1.53%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Urinary tract infection † 1  1/131 (0.76%)  0/6 (0.00%)  1/129 (0.78%)  1/6 (16.67%)  0/1 (0.00%) 
Viral infection † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Injury, poisoning and procedural complications           
Fall † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Radiation oesophagitis † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Investigations           
Blood potassium decreased † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
C-reactive protein increased † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Electrocardiogram abnormal † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Metabolism and nutrition disorders           
Dehydration † 1  2/131 (1.53%)  0/6 (0.00%)  3/129 (2.33%)  0/6 (0.00%)  0/1 (0.00%) 
Failure to thrive † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Hypercalcaemia † 1  4/131 (3.05%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Hyperglycaemia † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Hypoglycaemia † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Hypokalaemia † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Hypomagnesaemia † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Hyponatraemia † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Hypophosphataemia † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Musculoskeletal and connective tissue disorders           
Back pain † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Musculoskeletal pain † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Neck pain † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Basal cell carcinoma † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Gastric cancer † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Lung neoplasm malignant † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Malignant neoplasm progression † 1  40/131 (30.53%)  0/6 (0.00%)  36/129 (27.91%)  0/6 (0.00%)  0/1 (0.00%) 
Metastases to central nervous system † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Squamous cell carcinoma † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Tumour pain † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Nervous system disorders           
Aphasia † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Cerebrovascular accident † 1  0/131 (0.00%)  0/6 (0.00%)  2/129 (1.55%)  1/6 (16.67%)  0/1 (0.00%) 
Dizziness † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Facial paralysis † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Generalised tonic-clonic seizure † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Ischaemic stroke † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Myasthenic syndrome † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Peripheral sensory neuropathy † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Seizure † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Spinal cord compression † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Syncope † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Psychiatric disorders           
Confusional state † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Delirium † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Mental status changes † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Renal and urinary disorders           
Haematuria † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Tubulointerstitial nephritis † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Ureterolithiasis † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Acute respiratory failure † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Bronchial obstruction † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Chronic obstructive pulmonary disease † 1  2/131 (1.53%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Cough † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Dyspnoea † 1  4/131 (3.05%)  0/6 (0.00%)  4/129 (3.10%)  0/6 (0.00%)  0/1 (0.00%) 
Haemoptysis † 1  1/131 (0.76%)  0/6 (0.00%)  2/129 (1.55%)  0/6 (0.00%)  0/1 (0.00%) 
Interstitial lung disease † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Oropharyngeal pain † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Pleural effusion † 1  1/131 (0.76%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Pneumonitis † 1  2/131 (1.53%)  1/6 (16.67%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Pneumothorax † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Pulmonary embolism † 1  3/131 (2.29%)  0/6 (0.00%)  2/129 (1.55%)  0/6 (0.00%)  0/1 (0.00%) 
Pulmonary haemorrhage † 1  1/131 (0.76%)  0/6 (0.00%)  4/129 (3.10%)  0/6 (0.00%)  0/1 (0.00%) 
Pulmonary thrombosis † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Respiratory distress † 1  0/131 (0.00%)  0/6 (0.00%)  0/129 (0.00%)  1/6 (16.67%)  0/1 (0.00%) 
Respiratory failure † 1  3/131 (2.29%)  0/6 (0.00%)  5/129 (3.88%)  0/6 (0.00%)  0/1 (0.00%) 
Stridor † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Vascular disorders           
Aortic aneurysm rupture † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Arterial haemorrhage † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Peripheral ischaemia † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Superior vena cava syndrome † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
1
Term from vocabulary, 24.0
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Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nivolumab 3 mg/kg Nivolumab 480 mg Docetaxel Extension Phase of Docetaxel Arm: Nivolumab 3 mg/kg Extension Phase of Docetaxel Arm: Nivolumab 480 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   120/131 (91.60%)   4/6 (66.67%)   123/129 (95.35%)   4/6 (66.67%)   1/1 (100.00%) 
Blood and lymphatic system disorders           
Anaemia † 1  27/131 (20.61%)  0/6 (0.00%)  43/129 (33.33%)  0/6 (0.00%)  0/1 (0.00%) 
Leukopenia † 1  3/131 (2.29%)  0/6 (0.00%)  11/129 (8.53%)  0/6 (0.00%)  0/1 (0.00%) 
Neutropenia † 1  4/131 (3.05%)  0/6 (0.00%)  43/129 (33.33%)  0/6 (0.00%)  0/1 (0.00%) 
Cardiac disorders           
Hypertensive heart disease † 1  0/131 (0.00%)  1/6 (16.67%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Endocrine disorders           
Hypothyroidism † 1  7/131 (5.34%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Adrenal insufficiency † 1  0/131 (0.00%)  0/6 (0.00%)  0/129 (0.00%)  1/6 (16.67%)  0/1 (0.00%) 
Cushing's syndrome † 1  0/131 (0.00%)  0/6 (0.00%)  0/129 (0.00%)  1/6 (16.67%)  0/1 (0.00%) 
Eye disorders           
Blepharochalasis † 1  0/131 (0.00%)  0/6 (0.00%)  0/129 (0.00%)  1/6 (16.67%)  0/1 (0.00%) 
Trichiasis † 1  0/131 (0.00%)  0/6 (0.00%)  0/129 (0.00%)  1/6 (16.67%)  0/1 (0.00%) 
Visual impairment † 1  4/131 (3.05%)  1/6 (16.67%)  2/129 (1.55%)  0/6 (0.00%)  0/1 (0.00%) 
Gastrointestinal disorders           
Abdominal pain † 1  8/131 (6.11%)  1/6 (16.67%)  10/129 (7.75%)  0/6 (0.00%)  0/1 (0.00%) 
Constipation † 1  18/131 (13.74%)  0/6 (0.00%)  19/129 (14.73%)  0/6 (0.00%)  0/1 (0.00%) 
Diarrhoea † 1  24/131 (18.32%)  1/6 (16.67%)  34/129 (26.36%)  0/6 (0.00%)  0/1 (0.00%) 
Nausea † 1  24/131 (18.32%)  2/6 (33.33%)  33/129 (25.58%)  2/6 (33.33%)  0/1 (0.00%) 
Vomiting † 1  12/131 (9.16%)  2/6 (33.33%)  19/129 (14.73%)  1/6 (16.67%)  0/1 (0.00%) 
Anal ulcer † 1  0/131 (0.00%)  0/6 (0.00%)  0/129 (0.00%)  1/6 (16.67%)  0/1 (0.00%) 
Dry mouth † 1  3/131 (2.29%)  0/6 (0.00%)  2/129 (1.55%)  1/6 (16.67%)  0/1 (0.00%) 
Dyspepsia † 1  4/131 (3.05%)  0/6 (0.00%)  4/129 (3.10%)  1/6 (16.67%)  0/1 (0.00%) 
Epigastric discomfort † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  1/6 (16.67%)  0/1 (0.00%) 
Glossodynia † 1  0/131 (0.00%)  0/6 (0.00%)  0/129 (0.00%)  1/6 (16.67%)  0/1 (0.00%) 
Haemorrhoids † 1  0/131 (0.00%)  0/6 (0.00%)  3/129 (2.33%)  1/6 (16.67%)  0/1 (0.00%) 
Oesophageal compression † 1  0/131 (0.00%)  0/6 (0.00%)  0/129 (0.00%)  1/6 (16.67%)  0/1 (0.00%) 
Toothache † 1  0/131 (0.00%)  0/6 (0.00%)  0/129 (0.00%)  1/6 (16.67%)  0/1 (0.00%) 
General disorders           
Asthenia † 1  25/131 (19.08%)  1/6 (16.67%)  27/129 (20.93%)  1/6 (16.67%)  0/1 (0.00%) 
Chest pain † 1  6/131 (4.58%)  0/6 (0.00%)  10/129 (7.75%)  1/6 (16.67%)  0/1 (0.00%) 
Chills † 1  9/131 (6.87%)  1/6 (16.67%)  2/129 (1.55%)  1/6 (16.67%)  0/1 (0.00%) 
Fatigue † 1  42/131 (32.06%)  0/6 (0.00%)  52/129 (40.31%)  1/6 (16.67%)  0/1 (0.00%) 
Mucosal inflammation † 1  3/131 (2.29%)  0/6 (0.00%)  13/129 (10.08%)  0/6 (0.00%)  0/1 (0.00%) 
Non-cardiac chest pain † 1  8/131 (6.11%)  0/6 (0.00%)  2/129 (1.55%)  0/6 (0.00%)  0/1 (0.00%) 
Oedema peripheral † 1  11/131 (8.40%)  0/6 (0.00%)  16/129 (12.40%)  0/6 (0.00%)  0/1 (0.00%) 
Pain † 1  8/131 (6.11%)  1/6 (16.67%)  6/129 (4.65%)  0/6 (0.00%)  0/1 (0.00%) 
Pyrexia † 1  27/131 (20.61%)  0/6 (0.00%)  26/129 (20.16%)  3/6 (50.00%)  0/1 (0.00%) 
Generalised oedema † 1  1/131 (0.76%)  0/6 (0.00%)  1/129 (0.78%)  1/6 (16.67%)  0/1 (0.00%) 
Sensation of foreign body † 1  0/131 (0.00%)  0/6 (0.00%)  0/129 (0.00%)  1/6 (16.67%)  0/1 (0.00%) 
Malaise † 1  2/131 (1.53%)  1/6 (16.67%)  2/129 (1.55%)  0/6 (0.00%)  0/1 (0.00%) 
Infections and infestations           
Bronchitis † 1  14/131 (10.69%)  1/6 (16.67%)  4/129 (3.10%)  0/6 (0.00%)  0/1 (0.00%) 
Pneumonia † 1  6/131 (4.58%)  0/6 (0.00%)  7/129 (5.43%)  0/6 (0.00%)  0/1 (0.00%) 
Upper respiratory tract infection † 1  8/131 (6.11%)  0/6 (0.00%)  5/129 (3.88%)  0/6 (0.00%)  0/1 (0.00%) 
Urinary tract infection † 1  4/131 (3.05%)  0/6 (0.00%)  6/129 (4.65%)  1/6 (16.67%)  0/1 (0.00%) 
Nasopharyngitis † 1  4/131 (3.05%)  0/6 (0.00%)  6/129 (4.65%)  1/6 (16.67%)  0/1 (0.00%) 
Oral candidiasis † 1  1/131 (0.76%)  0/6 (0.00%)  6/129 (4.65%)  1/6 (16.67%)  0/1 (0.00%) 
Paronychia † 1  2/131 (1.53%)  0/6 (0.00%)  1/129 (0.78%)  1/6 (16.67%)  0/1 (0.00%) 
Pustule † 1  0/131 (0.00%)  0/6 (0.00%)  0/129 (0.00%)  1/6 (16.67%)  0/1 (0.00%) 
Respiratory tract infection † 1  2/131 (1.53%)  0/6 (0.00%)  4/129 (3.10%)  1/6 (16.67%)  0/1 (0.00%) 
Respiratory tract infection viral † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  1/6 (16.67%)  0/1 (0.00%) 
Injury, poisoning and procedural complications           
Traumatic haematoma † 1  0/131 (0.00%)  0/6 (0.00%)  0/129 (0.00%)  1/6 (16.67%)  0/1 (0.00%) 
Vascular access site haematoma † 1  0/131 (0.00%)  0/6 (0.00%)  0/129 (0.00%)  1/6 (16.67%)  0/1 (0.00%) 
Investigations           
Blood alkaline phosphatase increased † 1  8/131 (6.11%)  0/6 (0.00%)  3/129 (2.33%)  0/6 (0.00%)  0/1 (0.00%) 
Neutrophil count decreased † 1  0/131 (0.00%)  0/6 (0.00%)  8/129 (6.20%)  0/6 (0.00%)  0/1 (0.00%) 
Weight decreased † 1  13/131 (9.92%)  0/6 (0.00%)  8/129 (6.20%)  1/6 (16.67%)  0/1 (0.00%) 
White blood cell count decreased † 1  0/131 (0.00%)  0/6 (0.00%)  8/129 (6.20%)  0/6 (0.00%)  0/1 (0.00%) 
Alanine aminotransferase increased † 1  4/131 (3.05%)  0/6 (0.00%)  3/129 (2.33%)  1/6 (16.67%)  0/1 (0.00%) 
Aspartate aminotransferase increased † 1  4/131 (3.05%)  0/6 (0.00%)  3/129 (2.33%)  1/6 (16.67%)  0/1 (0.00%) 
Blood creatinine increased † 1  6/131 (4.58%)  0/6 (0.00%)  2/129 (1.55%)  1/6 (16.67%)  0/1 (0.00%) 
Metabolism and nutrition disorders           
Decreased appetite † 1  35/131 (26.72%)  0/6 (0.00%)  41/129 (31.78%)  2/6 (33.33%)  0/1 (0.00%) 
Hypercalcaemia † 1  7/131 (5.34%)  0/6 (0.00%)  2/129 (1.55%)  1/6 (16.67%)  0/1 (0.00%) 
Hyperglycaemia † 1  9/131 (6.87%)  0/6 (0.00%)  10/129 (7.75%)  0/6 (0.00%)  0/1 (0.00%) 
Hypokalaemia † 1  7/131 (5.34%)  0/6 (0.00%)  4/129 (3.10%)  0/6 (0.00%)  0/1 (0.00%) 
Hypomagnesaemia † 1  8/131 (6.11%)  0/6 (0.00%)  5/129 (3.88%)  0/6 (0.00%)  0/1 (0.00%) 
Dehydration † 1  6/131 (4.58%)  0/6 (0.00%)  5/129 (3.88%)  1/6 (16.67%)  0/1 (0.00%) 
Gout † 1  0/131 (0.00%)  0/6 (0.00%)  0/129 (0.00%)  1/6 (16.67%)  0/1 (0.00%) 
Hyponatraemia † 1  4/131 (3.05%)  0/6 (0.00%)  5/129 (3.88%)  1/6 (16.67%)  0/1 (0.00%) 
Vitamin D deficiency † 1  0/131 (0.00%)  0/6 (0.00%)  0/129 (0.00%)  1/6 (16.67%)  0/1 (0.00%) 
Musculoskeletal and connective tissue disorders           
Arthralgia † 1  17/131 (12.98%)  0/6 (0.00%)  19/129 (14.73%)  0/6 (0.00%)  0/1 (0.00%) 
Back pain † 1  14/131 (10.69%)  0/6 (0.00%)  12/129 (9.30%)  0/6 (0.00%)  0/1 (0.00%) 
Bone pain † 1  3/131 (2.29%)  0/6 (0.00%)  7/129 (5.43%)  0/6 (0.00%)  0/1 (0.00%) 
Musculoskeletal chest pain † 1  7/131 (5.34%)  0/6 (0.00%)  3/129 (2.33%)  1/6 (16.67%)  0/1 (0.00%) 
Myalgia † 1  3/131 (2.29%)  0/6 (0.00%)  15/129 (11.63%)  0/6 (0.00%)  0/1 (0.00%) 
Arthritis † 1  0/131 (0.00%)  0/6 (0.00%)  0/129 (0.00%)  1/6 (16.67%)  0/1 (0.00%) 
Muscle spasms † 1  2/131 (1.53%)  1/6 (16.67%)  1/129 (0.78%)  1/6 (16.67%)  0/1 (0.00%) 
Neck pain † 1  3/131 (2.29%)  0/6 (0.00%)  3/129 (2.33%)  1/6 (16.67%)  0/1 (0.00%) 
Nervous system disorders           
Dizziness † 1  13/131 (9.92%)  0/6 (0.00%)  13/129 (10.08%)  0/6 (0.00%)  0/1 (0.00%) 
Headache † 1  18/131 (13.74%)  1/6 (16.67%)  10/129 (7.75%)  0/6 (0.00%)  0/1 (0.00%) 
Neuropathy peripheral † 1  4/131 (3.05%)  0/6 (0.00%)  14/129 (10.85%)  0/6 (0.00%)  0/1 (0.00%) 
Paraesthesia † 1  5/131 (3.82%)  0/6 (0.00%)  9/129 (6.98%)  0/6 (0.00%)  0/1 (0.00%) 
Parkinson's disease † 1  0/131 (0.00%)  1/6 (16.67%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Psychiatric disorders           
Insomnia † 1  9/131 (6.87%)  0/6 (0.00%)  7/129 (5.43%)  0/6 (0.00%)  0/1 (0.00%) 
Reproductive system and breast disorders           
Benign prostatic hyperplasia † 1  0/131 (0.00%)  1/6 (16.67%)  0/129 (0.00%)  0/6 (0.00%)  0/1 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Cough † 1  45/131 (34.35%)  1/6 (16.67%)  24/129 (18.60%)  1/6 (16.67%)  0/1 (0.00%) 
Dysphonia † 1  10/131 (7.63%)  1/6 (16.67%)  1/129 (0.78%)  0/6 (0.00%)  0/1 (0.00%) 
Dyspnoea † 1  47/131 (35.88%)  0/6 (0.00%)  39/129 (30.23%)  0/6 (0.00%)  0/1 (0.00%) 
Haemoptysis † 1  9/131 (6.87%)  0/6 (0.00%)  10/129 (7.75%)  1/6 (16.67%)  0/1 (0.00%) 
Productive cough † 1  7/131 (5.34%)  0/6 (0.00%)  5/129 (3.88%)  0/6 (0.00%)  0/1 (0.00%) 
Pneumonitis † 1  5/131 (3.82%)  0/6 (0.00%)  1/129 (0.78%)  0/6 (0.00%)  1/1 (100.00%) 
Sputum discoloured † 1  0/131 (0.00%)  0/6 (0.00%)  0/129 (0.00%)  1/6 (16.67%)  0/1 (0.00%) 
Skin and subcutaneous tissue disorders           
Alopecia † 1  2/131 (1.53%)  0/6 (0.00%)  30/129 (23.26%)  0/6 (0.00%)  0/1 (0.00%) 
Pruritus † 1  11/131 (8.40%)  0/6 (0.00%)  3/129 (2.33%)  2/6 (33.33%)  0/1 (0.00%) 
Rash † 1  12/131 (9.16%)  0/6 (0.00%)  12/129 (9.30%)  0/6 (0.00%)  0/1 (0.00%) 
Dry skin † 1  5/131 (3.82%)  0/6 (0.00%)  5/129 (3.88%)  2/6 (33.33%)  0/1 (0.00%) 
Erythema † 1  1/131 (0.76%)  0/6 (0.00%)  3/129 (2.33%)  1/6 (16.67%)  0/1 (0.00%) 
Pain of skin † 1  0/131 (0.00%)  0/6 (0.00%)  0/129 (0.00%)  1/6 (16.67%)  0/1 (0.00%) 
Rash erythematous † 1  1/131 (0.76%)  0/6 (0.00%)  0/129 (0.00%)  1/6 (16.67%)  0/1 (0.00%) 
Rash macular † 1  0/131 (0.00%)  0/6 (0.00%)  1/129 (0.78%)  1/6 (16.67%)  0/1 (0.00%) 
Xanthelasma † 1  0/131 (0.00%)  0/6 (0.00%)  0/129 (0.00%)  0/6 (0.00%)  1/1 (100.00%) 
Vascular disorders           
Hypotension † 1  7/131 (5.34%)  0/6 (0.00%)  5/129 (3.88%)  1/6 (16.67%)  0/1 (0.00%) 
Hot flush † 1  2/131 (1.53%)  0/6 (0.00%)  3/129 (2.33%)  1/6 (16.67%)  0/1 (0.00%) 
1
Term from vocabulary, 24.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators 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
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Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
Phone: Please email
EMail: Clinical.Trials@bms.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01642004    
Other Study ID Numbers: CA209-017
2011-004792-36 ( EudraCT Number )
First Submitted: July 9, 2012
First Posted: July 17, 2012
Results First Submitted: February 19, 2016
Results First Posted: March 17, 2016
Last Update Posted: December 28, 2022