Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Metastatic Non-squamous NSCLC (CheckMate057)

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ClinicalTrials.gov Identifier: NCT01673867

Recruitment Status : Completed

First Posted : August 28, 2012

Results First Posted : February 26, 2016

Last Update Posted : February 8, 2023

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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	Non-Squamous Cell Non-small Cell Lung Cancer
Interventions	Biological: Nivolumab Drug: Docetaxel
Enrollment	582

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Nivolumab	Docetaxel
Arm/Group Description	Nivolumab 3 mg/kg solution administ...	Docetaxel 75mg/m^2 solution adminis...
Arm/Group Description	Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.	Docetaxel 75mg/m^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
Period Title: Randomization
Started ^[1]	292	290
Completed ^[2]	287	268
Not Completed	5	22
Reason Not Completed
Adverse event unrelated to study drug	1	0
Participant request to discontinue study treatment	0	4
Withdrawal by participant	0	12
Lost to Follow-up	0	1
Participant no longer meets study criteria	4	5
[1] Started = Randomized [2] Completed = Received treatment
Period Title: Treatment
Started ^[1]	287	268
Participants Who Transitioned to Nivolumab 3 mg/kg	0	17
Participants Who Transitioned to Nivolumab 480 mg	15	1
Completed ^[2]	2	0
Not Completed	285	268
Reason Not Completed
Disease Progression	208	178
Study Drug Toxicity	23	43
Death	2	3
Adverse event unrelated to study drug	23	10
Participant request to discontinue study treatment	7	17
Withdrawal by participant	5	5
Maximum clinical benefit	1	10
Participant no longer meets study criteria	2	0
Administrative reason by sponsor	3	0
Other reason	11	2
[1] Started = Received treatment [2] Completed = Completed treatment period

Baseline Characteristics

Arm/Group Title		Nivolumab	Docetaxel	Total
Arm/Group Description		Nivolumab 3 mg/kg solution administ...	Docetaxel 75mg/m^2 solution adminis...	Total of all reporting groups
Arm/Group Description		Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.	Docetaxel 75mg/m^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.	Total of all reporting groups
Overall Number of Baseline Participants		292	290	582
Baseline Analysis Population Description		...
Baseline Analysis Population Description		All randomized participants
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	292 participants	290 participants	582 participants
		60.9 (9.27)	62.3 (9.75)	61.6 (9.53)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	292 participants	290 participants	582 participants
	Female	141 48.3%	122 42.1%	263 45.2%
	Male	151 51.7%	168 57.9%	319 54.8%
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	292 participants	290 participants	582 participants
American Indian or Alaska Native		1 0.3%	0 0.0%	1 0.2%
Asian		9 3.1%	8 2.8%	17 2.9%
Native Hawaiian or Other Pacific Islander		0 0.0%	1 0.3%	1 0.2%
Black or African American		7 2.4%	9 3.1%	16 2.7%
White		267 91.4%	266 91.7%	533 91.6%
Other		8 2.7%	6 2.1%	14 2.4%
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	292 participants	290 participants	582 participants
Hispanic or Latino		19 6.5%	16 5.5%	35 6.0%
Not Hispanic or Latino		135 46.2%	141 48.6%	276 47.4%
Not Reported		138 47.3%	133 45.9%	271 46.6%

Outcome Measures

1.Primary Outcome


Title	Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint
Description	Overall survival was defined as the time from randomization to the dat...
Description	Overall survival was defined as the time from randomization to the date of death. A participant who has not died will be censored at last known date alive. OS will be followed continuously while participants are on the study drug and every 3 months via in-person or phone contact after participants discontinue the study drug. Median and hazard ratio computed using Kaplan-Meier method.
Time Frame	Randomization until 413 deaths, up to March 2015 (approximately 29 months)

Outcome Measure Data

Analysis Population Description

All randomized participants


Arm/Group Title	Nivolumab	Docetaxel
Arm/Group Description:	Nivolumab 3 mg/kg solution administ...	Docetaxel 75mg/m^2 solution adminis...
Arm/Group Description:	Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.	Docetaxel 75mg/m^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
Overall Number of Participants Analyzed	292	290
Median (95% Confidence Interval) Unit of Measure: Months
	12.19 (9.66 to 14.98)	9.36 (8.05 to 10.68)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Nivolumab, Docetaxel
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0015
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.73
	Confidence Interval	(2-Sided) 95.92% 0.59 to 0.89
	Estimation Comments	HR = Nivolumab over docetaxel

2.Secondary Outcome


Title	Objective Response Rate (ORR)
Description	ORR was defined as the percentage of participants whose Best Overall R...
Description	ORR was defined as the percentage of 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. CR+PR, confidence interval based on the Clopper and Pearson method.
Time Frame	From randomization to date of objectively documented progression (up to approximately 110 months)

Outcome Measure Data

Analysis Population Description

All randomized participants


Arm/Group Title	Nivolumab	Docetaxel
Arm/Group Description:	Nivolumab 3 mg/kg solution administ...	Docetaxel 75mg/m^2 solution adminis...
Arm/Group Description:	Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.	Docetaxel 75mg/m^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
Overall Number of Participants Analyzed	292	290
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: Percentage of participants
	19.5 (15.1 to 24.5)	12.8 (9.1 to 17.2)

3.Secondary Outcome


Title	Time To Objective Response (TTOR)
Description	Time to Objective Response for participants demonstrating a response (...
Description	Time to Objective Response 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 randomization to the date of first confirmed response (up to approximately 110 months)

Outcome Measure Data

Analysis Population Description

All randomized participants who demonstrate partial response (PR) or complete response (CR)


Arm/Group Title	Nivolumab	Docetaxel
Arm/Group Description:	Nivolumab 3 mg/kg solution administ...	Docetaxel 75mg/m^2 solution adminis...
Arm/Group Description:	Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.	Docetaxel 75mg/m^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
Overall Number of Participants Analyzed	57	37
Median (Full Range) Unit of Measure: Months
	2.10 (1.2 to 34.6)	2.73 (1.4 to 31.2)

4.Secondary Outcome


Title	Duration of Objective Response (DOOR)
Description	DOR was defined as the time from the date of first confirmed response ...
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. Median computed using Kaplan-Meier method.
Time Frame	From randomization to date of first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 110 months)

Outcome Measure Data

Analysis Population Description

All randomized participants who demonstrate partial response (PR) or complete response (CR)


Arm/Group Title	Nivolumab	Docetaxel
Arm/Group Description:	Nivolumab 3 mg/kg solution administ...	Docetaxel 75mg/m^2 solution adminis...
Arm/Group Description:	Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.	Docetaxel 75mg/m^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
Overall Number of Participants Analyzed	57	37
Median (95% Confidence Interval) Unit of Measure: Months
	17.15 (10.78 to 30.75)	5.55 (4.40 to 7.03)

5.Secondary Outcome


Title	Progression-Free Survival (PFS)
Description	PFS was defined as the time from randomization to the date of the firs...
Description	PFS was defined as the time from randomization to the date of the first documented tumor progression (per RECIST 1.1) or death due to any cause. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Progression will be assessed every 6 weeks (from the first on-study radiographic assessment) until disease progression is noted. Progressive disease was defined as least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Median computed using the Kaplan-Meier method.
Time Frame	From randomization to first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 110 months)

Outcome Measure Data

Analysis Population Description

All randomized participants


Arm/Group Title	Nivolumab	Docetaxel
Arm/Group Description:	Nivolumab 3 mg/kg solution administ...	Docetaxel 75mg/m^2 solution adminis...
Arm/Group Description:	Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.	Docetaxel 75mg/m^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
Overall Number of Participants Analyzed	292	290
Median (95% Confidence Interval) Unit of Measure: Months
	2.33 (2.17 to 3.32)	4.44 (3.45 to 4.86)

6.Secondary Outcome


Title	Percentage of Participants Experiencing Disease-Related Symptom Improvement by Week 12
Description	Disease-related symptom improvement rate by Week 12 was defined as the...
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	Randomization to Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants


Arm/Group Title	Nivolumab	Docetaxel
Arm/Group Description:	Nivolumab 3 mg/kg solution administ...	Docetaxel 75mg/m^2 solution adminis...
Arm/Group Description:	Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.	Docetaxel 75mg/m^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
Overall Number of Participants Analyzed	292	290
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: Percentage of participants
	17.8 (13.6 to 22.7)	19.7 (15.2 to 24.7)

7.Secondary Outcome


Title	Overall Survival (OS) by PD-L1 Expression at Baseline
Description	Overall survival was defined as the time from randomization to the dat...
Description	Overall survival was defined as the time from randomization to the date of death. A participant who has not died will be censored at last known date alive. Overall Survival time was measured in months for all randomized participants grouped by their baseline PD-L1 expression level. 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. Median computed using the Kaplan-Meier method.
Time Frame	From randomization to the date of death or last known date alive (up to approximately 110 months)

Outcome Measure Data

Analysis Population Description

All randomized participants who had a tumor biopsy assessed for PD-L1 expression


Arm/Group Title		Nivolumab	Docetaxel
Arm/Group Description:		Nivolumab 3 mg/kg solution administ...	Docetaxel 75mg/m^2 solution adminis...
Arm/Group Description:		Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.	Docetaxel 75mg/m^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
Overall Number of Participants Analyzed		231	224
Median (95% Confidence Interval) Unit of Measure: Months
Participants with baseline PD-L1 expression ≥ 5%	Number Analyzed	94 participants	86 participants
Participants with baseline PD-L1 expression ≥ 5%		19.91 (15.08 to 26.12)	8.11 (6.47 to 10.05)
Participants with baseline PD-L1 expression < 5%	Number Analyzed	137 participants	138 participants
Participants with baseline PD-L1 expression < 5%		9.86 (6.93 to 12.81)	10.28 (8.54 to 11.96)

8.Secondary Outcome


Title	Objective Response Rate (ORR) by PD-L1 Expression at Baseline
Description	ORR was defined as the percentage of all randomized participants whose...
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). 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. CR+PR, confidence interval based on the Clopper and Pearson method. ORR was reported for all randomized participants grouped by their baseline PD-L1 expression level. 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.
Time Frame	From randomization to date of objectively documented progression (up to approximately 110 months)

Outcome Measure Data

Analysis Population Description

All randomized participants who had a tumor biopsy assessed for PD-L1 expression


Arm/Group Title		Nivolumab	Docetaxel
Arm/Group Description:		Nivolumab 3 mg/kg solution administ...	Docetaxel 75mg/m^2 solution adminis...
Arm/Group Description:		Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.	Docetaxel 75mg/m^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
Overall Number of Participants Analyzed		231	224
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: Percentage of participants
Participants with baseline PD-L1 expression ≥ 5%	Number Analyzed	94 participants	86 participants
Participants with baseline PD-L1 expression ≥ 5%		36.2 (26.5 to 46.7)	12.8 (6.6 to 21.7)
Participants with baseline PD-L1 expression < 5%	Number Analyzed	137 participants	138 participants
Participants with baseline PD-L1 expression < 5%		10.9 (6.3 to 17.4)	14.5 (9.1 to 21.5)

9.Post-Hoc Outcome


Title	Overall Survival (OS) - Extended Collection
Description	Overall survival was defined as the time from randomization to the dat...
Description	Overall survival was defined as the time from randomization to the date of death. A participant who has not died will be censored at last known date alive. OS will be followed continuously while participants are on the study drug and every 3 months via in-person or phone contact after participants discontinue the study drug. Median computed using Kaplan-Meier method. Note: This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date. (Assessments were made until December 17, 2021).
Time Frame	From randomization to the date of death or last known date alive (up to approximately 110 months)

Outcome Measure Data

Analysis Population Description

All randomized participants


Arm/Group Title	Nivolumab	Docetaxel
Arm/Group Description:	Nivolumab 3 mg/kg solution administ...	Docetaxel 75mg/m^2 solution adminis...
Arm/Group Description:	Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.	Docetaxel 75mg/m^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
Overall Number of Participants Analyzed	292	290
Median (95% Confidence Interval) Unit of Measure: Months
	12.21 (9.66 to 15.08)	9.49 (8.11 to 10.74)

Adverse Events

Time Frame	Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 110 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 108 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 3 mg/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 3 mg/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
Arm/Group Description	Nivolumab 3 mg/kg solution administ...	Nivolumab 480 mg solution administe...	Docetaxel 75mg/m^2 solution adminis...	Eligible participants from the Doce...	Eligible participants from the Doce...
Arm/Group Description	Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.	Nivolumab 480 mg solution administered intravenously every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.	Docetaxel 75mg/m^2 solution administered intravenously every 3 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.	Eligible participants from the Docetaxel arm who transitioned to nivolumab 3 mg/kg every 2 weeks via extension phase. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.	Eligible participants from the Docetaxel arm who transitioned to nivolumab 480 mg every 4 weeks via extension phase. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
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	258/292 (88.36%)	2/15 (13.33%)	266/290 (91.72%)	14/17 (82.35%)	0/1 (0.00%)
Serious Adverse Events 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	172/287 (59.93%)	5/15 (33.33%)	161/268 (60.07%)	9/17 (52.94%)	1/1 (100.00%)
Blood and lymphatic system disorders
Anaemia ^† 1	3/287 (1.05%)	0/15 (0.00%)	4/268 (1.49%)	0/17 (0.00%)	0/1 (0.00%)
Febrile neutropenia ^† 1	1/287 (0.35%)	0/15 (0.00%)	24/268 (8.96%)	0/17 (0.00%)	0/1 (0.00%)
Haematotoxicity ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Leukopenia ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Neutropenia ^† 1	0/287 (0.00%)	0/15 (0.00%)	8/268 (2.99%)	0/17 (0.00%)	0/1 (0.00%)
Thrombotic thrombocytopenic purpura ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Cardiac disorders
Atrial fibrillation ^† 1	2/287 (0.70%)	0/15 (0.00%)	2/268 (0.75%)	0/17 (0.00%)	0/1 (0.00%)
Atrial flutter ^† 1	1/287 (0.35%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Cardiac arrest ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Cardiac failure ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	1/17 (5.88%)	0/1 (0.00%)
Cardiac tamponade ^† 1	1/287 (0.35%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Cardio-respiratory arrest ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Cardiopulmonary failure ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Cardiovascular disorder ^† 1	0/287 (0.00%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	1/1 (100.00%)
Pericardial effusion ^† 1	2/287 (0.70%)	0/15 (0.00%)	3/268 (1.12%)	0/17 (0.00%)	0/1 (0.00%)
Pericarditis ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Sinus node dysfunction ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Ear and labyrinth disorders
Vertigo ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Endocrine disorders
Adrenal insufficiency ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Eye disorders
Retinal tear ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Gastrointestinal disorders
Abdominal pain ^† 1	1/287 (0.35%)	0/15 (0.00%)	3/268 (1.12%)	0/17 (0.00%)	0/1 (0.00%)
Abdominal pain upper ^† 1	2/287 (0.70%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Ascites ^† 1	2/287 (0.70%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Colitis ^† 1	2/287 (0.70%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Constipation ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Diarrhoea ^† 1	4/287 (1.39%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Dysphagia ^† 1	2/287 (0.70%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Erosive oesophagitis ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Gastrointestinal haemorrhage ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Haematemesis ^† 1	1/287 (0.35%)	0/15 (0.00%)	2/268 (0.75%)	0/17 (0.00%)	0/1 (0.00%)
Inguinal hernia ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Intestinal perforation ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Large intestine perforation ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Nausea ^† 1	4/287 (1.39%)	0/15 (0.00%)	4/268 (1.49%)	0/17 (0.00%)	0/1 (0.00%)
Salivary hypersecretion ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Small intestinal obstruction ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Stomatitis ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Upper gastrointestinal haemorrhage ^† 1	1/287 (0.35%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Vomiting ^† 1	1/287 (0.35%)	0/15 (0.00%)	1/268 (0.37%)	1/17 (5.88%)	0/1 (0.00%)
General disorders
Asthenia ^† 1	3/287 (1.05%)	0/15 (0.00%)	3/268 (1.12%)	0/17 (0.00%)	0/1 (0.00%)
Chest pain ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Complication associated with device ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Disease progression ^† 1	0/287 (0.00%)	0/15 (0.00%)	3/268 (1.12%)	0/17 (0.00%)	0/1 (0.00%)
Fatigue ^† 1	1/287 (0.35%)	0/15 (0.00%)	2/268 (0.75%)	1/17 (5.88%)	0/1 (0.00%)
Gait disturbance ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
General physical health deterioration ^† 1	2/287 (0.70%)	0/15 (0.00%)	4/268 (1.49%)	1/17 (5.88%)	0/1 (0.00%)
Inflammation ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Malaise ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Mucosal inflammation ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Multiple organ dysfunction syndrome ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Non-cardiac chest pain ^† 1	3/287 (1.05%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Pain ^† 1	4/287 (1.39%)	0/15 (0.00%)	4/268 (1.49%)	0/17 (0.00%)	0/1 (0.00%)
Pyrexia ^† 1	6/287 (2.09%)	0/15 (0.00%)	4/268 (1.49%)	0/17 (0.00%)	0/1 (0.00%)
Sudden death ^† 1	2/287 (0.70%)	0/15 (0.00%)	3/268 (1.12%)	1/17 (5.88%)	0/1 (0.00%)
Hepatobiliary disorders
Cholecystitis ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Cholelithiasis ^† 1	2/287 (0.70%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Hepatotoxicity ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Infections and infestations
Bronchitis ^† 1	5/287 (1.74%)	1/15 (6.67%)	5/268 (1.87%)	0/17 (0.00%)	0/1 (0.00%)
COVID-19 ^† 1	0/287 (0.00%)	1/15 (6.67%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Cellulitis ^† 1	1/287 (0.35%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Clostridium difficile colitis ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Device related infection ^† 1	2/287 (0.70%)	1/15 (6.67%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Encephalitis ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Febrile infection ^† 1	0/287 (0.00%)	1/15 (6.67%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Fungal oesophagitis ^† 1	0/287 (0.00%)	0/15 (0.00%)	0/268 (0.00%)	1/17 (5.88%)	0/1 (0.00%)
Gastroenteritis norovirus ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Infected skin ulcer ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Infection ^† 1	2/287 (0.70%)	0/15 (0.00%)	2/268 (0.75%)	0/17 (0.00%)	0/1 (0.00%)
Lower respiratory tract infection ^† 1	0/287 (0.00%)	0/15 (0.00%)	0/268 (0.00%)	1/17 (5.88%)	0/1 (0.00%)
Lung abscess ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Nail infection ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Osteomyelitis ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Pneumocystis jirovecii pneumonia ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Pneumonia ^† 1	22/287 (7.67%)	1/15 (6.67%)	18/268 (6.72%)	1/17 (5.88%)	0/1 (0.00%)
Pneumonia bacterial ^† 1	2/287 (0.70%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Pneumonia mycoplasmal ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Pneumonia necrotising ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Post procedural pneumonia ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Postoperative wound infection ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Pulmonary sepsis ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Respiratory tract infection ^† 1	2/287 (0.70%)	0/15 (0.00%)	3/268 (1.12%)	0/17 (0.00%)	0/1 (0.00%)
Sepsis ^† 1	1/287 (0.35%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Septic shock ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Spontaneous bacterial peritonitis ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Staphylococcal sepsis ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Upper respiratory tract infection ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Urinary tract infection ^† 1	1/287 (0.35%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Vascular device infection ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	1/17 (5.88%)	0/1 (0.00%)
Injury, poisoning and procedural complications
Craniocerebral injury ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Fall ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Femur fracture ^† 1	0/287 (0.00%)	1/15 (6.67%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Infusion related reaction ^† 1	2/287 (0.70%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Pelvic fracture ^† 1	0/287 (0.00%)	1/15 (6.67%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Radius fracture ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Thoracic vertebral fracture ^† 1	0/287 (0.00%)	0/15 (0.00%)	2/268 (0.75%)	0/17 (0.00%)	0/1 (0.00%)
Wound dehiscence ^† 1	0/287 (0.00%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	1/1 (100.00%)
Wrist fracture ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Investigations
Alanine aminotransferase increased ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Aspartate aminotransferase increased ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Blood creatinine increased ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
General physical condition abnormal ^† 1	2/287 (0.70%)	0/15 (0.00%)	2/268 (0.75%)	0/17 (0.00%)	0/1 (0.00%)
Neutrophil count decreased ^† 1	1/287 (0.35%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Transaminases increased ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
White blood cell count decreased ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Metabolism and nutrition disorders
Decreased appetite ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Dehydration ^† 1	1/287 (0.35%)	0/15 (0.00%)	6/268 (2.24%)	0/17 (0.00%)	0/1 (0.00%)
Hyperglycaemia ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Hypokalaemia ^† 1	0/287 (0.00%)	0/15 (0.00%)	2/268 (0.75%)	0/17 (0.00%)	0/1 (0.00%)
Hypomagnesaemia ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Hyponatraemia ^† 1	1/287 (0.35%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Back pain ^† 1	2/287 (0.70%)	0/15 (0.00%)	4/268 (1.49%)	0/17 (0.00%)	0/1 (0.00%)
Bone pain ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Fistula ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Joint range of motion decreased ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Muscular weakness ^† 1	0/287 (0.00%)	0/15 (0.00%)	2/268 (0.75%)	0/17 (0.00%)	0/1 (0.00%)
Musculoskeletal chest pain ^† 1	2/287 (0.70%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Osteonecrosis ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Osteonecrosis of jaw ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Osteoporosis ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Osteoporotic fracture ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Pain in extremity ^† 1	2/287 (0.70%)	0/15 (0.00%)	2/268 (0.75%)	0/17 (0.00%)	0/1 (0.00%)
Pathological fracture ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Polymyalgia rheumatica ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Spinal pain ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Bladder transitional cell carcinoma ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Bladder transitional cell carcinoma recurrent ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Breast cancer ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Cancer pain ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Invasive ductal breast carcinoma ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Lung cancer metastatic ^† 1	0/287 (0.00%)	0/15 (0.00%)	0/268 (0.00%)	1/17 (5.88%)	0/1 (0.00%)
Lymphangiosis carcinomatosa ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Malignant neoplasm progression ^† 1	58/287 (20.21%)	0/15 (0.00%)	40/268 (14.93%)	2/17 (11.76%)	0/1 (0.00%)
Malignant pleural effusion ^† 1	1/287 (0.35%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Metastases to bone ^† 1	0/287 (0.00%)	0/15 (0.00%)	2/268 (0.75%)	0/17 (0.00%)	0/1 (0.00%)
Metastases to central nervous system ^† 1	3/287 (1.05%)	0/15 (0.00%)	3/268 (1.12%)	0/17 (0.00%)	0/1 (0.00%)
Metastases to meninges ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Metastases to spine ^† 1	1/287 (0.35%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Myelodysplastic syndrome ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Neoplasm malignant ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Neoplasm progression ^† 1	2/287 (0.70%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Non-small cell lung cancer ^† 1	5/287 (1.74%)	0/15 (0.00%)	10/268 (3.73%)	0/17 (0.00%)	0/1 (0.00%)
Non-small cell lung cancer metastatic ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Oncologic complication ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Ovarian neoplasm ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Pericardial effusion malignant ^† 1	1/287 (0.35%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Nervous system disorders
Carotid artery stenosis ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Central nervous system necrosis ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Cerebrovascular accident ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Depressed level of consciousness ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Epilepsy ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Headache ^† 1	4/287 (1.39%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Hemiparesis ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Hemiplegia ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Hydrocephalus ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
IVth nerve paresis ^† 1	0/287 (0.00%)	0/15 (0.00%)	0/268 (0.00%)	1/17 (5.88%)	0/1 (0.00%)
Nervous system disorder ^† 1	0/287 (0.00%)	0/15 (0.00%)	2/268 (0.75%)	0/17 (0.00%)	0/1 (0.00%)
Neuralgia ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Partial seizures ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Sciatica ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Seizure ^† 1	1/287 (0.35%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Somnolence ^† 1	1/287 (0.35%)	0/15 (0.00%)	2/268 (0.75%)	0/17 (0.00%)	0/1 (0.00%)
Spinal cord compression ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Syncope ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Psychiatric disorders
Confusional state ^† 1	2/287 (0.70%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Depression ^† 1	2/287 (0.70%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Disorientation ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Mental status changes ^† 1	0/287 (0.00%)	0/15 (0.00%)	3/268 (1.12%)	0/17 (0.00%)	0/1 (0.00%)
Panic attack ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Psychotic disorder ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Renal and urinary disorders
Acute kidney injury ^† 1	2/287 (0.70%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Haematuria ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Renal failure ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Tubulointerstitial nephritis ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Urinary retention ^† 1	2/287 (0.70%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure ^† 1	0/287 (0.00%)	0/15 (0.00%)	4/268 (1.49%)	0/17 (0.00%)	0/1 (0.00%)
Chronic obstructive pulmonary disease ^† 1	3/287 (1.05%)	1/15 (6.67%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Dyspnoea ^† 1	10/287 (3.48%)	1/15 (6.67%)	8/268 (2.99%)	0/17 (0.00%)	0/1 (0.00%)
Dyspnoea at rest ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Dyspnoea exertional ^† 1	0/287 (0.00%)	0/15 (0.00%)	0/268 (0.00%)	1/17 (5.88%)	0/1 (0.00%)
Haemoptysis ^† 1	2/287 (0.70%)	0/15 (0.00%)	3/268 (1.12%)	0/17 (0.00%)	0/1 (0.00%)
Hiccups ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Hydrothorax ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Hypoxia ^† 1	2/287 (0.70%)	0/15 (0.00%)	2/268 (0.75%)	0/17 (0.00%)	0/1 (0.00%)
Interstitial lung disease ^† 1	3/287 (1.05%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Lung infiltration ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Pleural effusion ^† 1	10/287 (3.48%)	0/15 (0.00%)	4/268 (1.49%)	1/17 (5.88%)	0/1 (0.00%)
Pneumonitis ^† 1	5/287 (1.74%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Pneumothorax ^† 1	0/287 (0.00%)	2/15 (13.33%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Pulmonary embolism ^† 1	13/287 (4.53%)	0/15 (0.00%)	5/268 (1.87%)	1/17 (5.88%)	0/1 (0.00%)
Pulmonary haemorrhage ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Respiratory disorder ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Respiratory failure ^† 1	10/287 (3.48%)	0/15 (0.00%)	4/268 (1.49%)	1/17 (5.88%)	0/1 (0.00%)
Skin and subcutaneous tissue disorders
Rash ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Vascular disorders
Deep vein thrombosis ^† 1	1/287 (0.35%)	0/15 (0.00%)	2/268 (0.75%)	0/17 (0.00%)	0/1 (0.00%)
Embolism ^† 1	1/287 (0.35%)	0/15 (0.00%)	2/268 (0.75%)	0/17 (0.00%)	0/1 (0.00%)
Jugular vein thrombosis ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Peripheral artery occlusion ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Peripheral artery stenosis ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Venous thrombosis ^† 1	0/287 (0.00%)	0/15 (0.00%)	0/268 (0.00%)	1/17 (5.88%)	0/1 (0.00%)
1 Term from vocabulary, 24.1 † Indicates events were collected by systematic assessment
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	267/287 (93.03%)	12/15 (80.00%)	258/268 (96.27%)	12/17 (70.59%)	1/1 (100.00%)
Blood and lymphatic system disorders
Anaemia ^† 1	37/287 (12.89%)	0/15 (0.00%)	68/268 (25.37%)	0/17 (0.00%)	0/1 (0.00%)
Leukopenia ^† 1	1/287 (0.35%)	0/15 (0.00%)	29/268 (10.82%)	1/17 (5.88%)	0/1 (0.00%)
Neutropenia ^† 1	3/287 (1.05%)	0/15 (0.00%)	82/268 (30.60%)	0/17 (0.00%)	0/1 (0.00%)
Lymphadenopathy ^† 1	3/287 (1.05%)	0/15 (0.00%)	1/268 (0.37%)	1/17 (5.88%)	0/1 (0.00%)
Cardiac disorders
Atrial fibrillation ^† 1	3/287 (1.05%)	0/15 (0.00%)	3/268 (1.12%)	0/17 (0.00%)	1/1 (100.00%)
Myocardial infarction ^† 1	0/287 (0.00%)	0/15 (0.00%)	0/268 (0.00%)	1/17 (5.88%)	0/1 (0.00%)
Pericardial effusion ^† 1	3/287 (1.05%)	0/15 (0.00%)	1/268 (0.37%)	1/17 (5.88%)	0/1 (0.00%)
Tachycardia ^† 1	6/287 (2.09%)	0/15 (0.00%)	8/268 (2.99%)	1/17 (5.88%)	0/1 (0.00%)
Ear and labyrinth disorders
Ear pain ^† 1	2/287 (0.70%)	1/15 (6.67%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Excessive cerumen production ^† 1	2/287 (0.70%)	1/15 (6.67%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Hypoacusis ^† 1	2/287 (0.70%)	0/15 (0.00%)	3/268 (1.12%)	1/17 (5.88%)	0/1 (0.00%)
Tympanic membrane perforation ^† 1	0/287 (0.00%)	1/15 (6.67%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Endocrine disorders
Hypothyroidism ^† 1	21/287 (7.32%)	0/15 (0.00%)	0/268 (0.00%)	2/17 (11.76%)	0/1 (0.00%)
Hyperthyroidism ^† 1	4/287 (1.39%)	0/15 (0.00%)	0/268 (0.00%)	1/17 (5.88%)	0/1 (0.00%)
Eye disorders
Lacrimation increased ^† 1	3/287 (1.05%)	0/15 (0.00%)	22/268 (8.21%)	0/17 (0.00%)	0/1 (0.00%)
Gastrointestinal disorders
Abdominal pain ^† 1	19/287 (6.62%)	0/15 (0.00%)	16/268 (5.97%)	1/17 (5.88%)	0/1 (0.00%)
Abdominal pain upper ^† 1	11/287 (3.83%)	0/15 (0.00%)	14/268 (5.22%)	1/17 (5.88%)	0/1 (0.00%)
Constipation ^† 1	69/287 (24.04%)	2/15 (13.33%)	50/268 (18.66%)	2/17 (11.76%)	0/1 (0.00%)
Diarrhoea ^† 1	57/287 (19.86%)	2/15 (13.33%)	74/268 (27.61%)	2/17 (11.76%)	0/1 (0.00%)
Nausea ^† 1	72/287 (25.09%)	2/15 (13.33%)	85/268 (31.72%)	4/17 (23.53%)	0/1 (0.00%)
Stomatitis ^† 1	8/287 (2.79%)	0/15 (0.00%)	24/268 (8.96%)	1/17 (5.88%)	0/1 (0.00%)
Vomiting ^† 1	44/287 (15.33%)	3/15 (20.00%)	30/268 (11.19%)	1/17 (5.88%)	0/1 (0.00%)
Dyspepsia ^† 1	7/287 (2.44%)	0/15 (0.00%)	12/268 (4.48%)	1/17 (5.88%)	0/1 (0.00%)
Dysphagia ^† 1	7/287 (2.44%)	1/15 (6.67%)	8/268 (2.99%)	1/17 (5.88%)	0/1 (0.00%)
General disorders
Asthenia ^† 1	60/287 (20.91%)	1/15 (6.67%)	63/268 (23.51%)	1/17 (5.88%)	0/1 (0.00%)
Fatigue ^† 1	96/287 (33.45%)	0/15 (0.00%)	104/268 (38.81%)	7/17 (41.18%)	0/1 (0.00%)
Mucosal inflammation ^† 1	6/287 (2.09%)	0/15 (0.00%)	19/268 (7.09%)	1/17 (5.88%)	0/1 (0.00%)
Non-cardiac chest pain ^† 1	17/287 (5.92%)	0/15 (0.00%)	18/268 (6.72%)	0/17 (0.00%)	0/1 (0.00%)
Oedema peripheral ^† 1	36/287 (12.54%)	0/15 (0.00%)	46/268 (17.16%)	1/17 (5.88%)	0/1 (0.00%)
Pain ^† 1	21/287 (7.32%)	0/15 (0.00%)	19/268 (7.09%)	0/17 (0.00%)	0/1 (0.00%)
Pyrexia ^† 1	37/287 (12.89%)	0/15 (0.00%)	44/268 (16.42%)	1/17 (5.88%)	0/1 (0.00%)
Chest discomfort ^† 1	2/287 (0.70%)	1/15 (6.67%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Chest pain ^† 1	11/287 (3.83%)	1/15 (6.67%)	6/268 (2.24%)	1/17 (5.88%)	0/1 (0.00%)
Influenza like illness ^† 1	3/287 (1.05%)	0/15 (0.00%)	3/268 (1.12%)	1/17 (5.88%)	1/1 (100.00%)
Nodule ^† 1	1/287 (0.35%)	1/15 (6.67%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Swelling ^† 1	1/287 (0.35%)	1/15 (6.67%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Infections and infestations
Nasopharyngitis ^† 1	14/287 (4.88%)	2/15 (13.33%)	11/268 (4.10%)	1/17 (5.88%)	0/1 (0.00%)
Pneumonia ^† 1	9/287 (3.14%)	2/15 (13.33%)	16/268 (5.97%)	0/17 (0.00%)	0/1 (0.00%)
Upper respiratory tract infection ^† 1	19/287 (6.62%)	1/15 (6.67%)	13/268 (4.85%)	2/17 (11.76%)	0/1 (0.00%)
Bronchitis ^† 1	10/287 (3.48%)	2/15 (13.33%)	7/268 (2.61%)	0/17 (0.00%)	0/1 (0.00%)
Campylobacter infection ^† 1	0/287 (0.00%)	1/15 (6.67%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Candida infection ^† 1	1/287 (0.35%)	0/15 (0.00%)	5/268 (1.87%)	1/17 (5.88%)	0/1 (0.00%)
Conjunctivitis ^† 1	6/287 (2.09%)	1/15 (6.67%)	4/268 (1.49%)	0/17 (0.00%)	0/1 (0.00%)
Lower respiratory tract infection ^† 1	1/287 (0.35%)	0/15 (0.00%)	0/268 (0.00%)	1/17 (5.88%)	0/1 (0.00%)
Oral candidiasis ^† 1	3/287 (1.05%)	0/15 (0.00%)	3/268 (1.12%)	1/17 (5.88%)	0/1 (0.00%)
Respiratory tract infection ^† 1	5/287 (1.74%)	0/15 (0.00%)	3/268 (1.12%)	1/17 (5.88%)	0/1 (0.00%)
Sinusitis ^† 1	13/287 (4.53%)	1/15 (6.67%)	3/268 (1.12%)	0/17 (0.00%)	0/1 (0.00%)
Urinary tract infection ^† 1	13/287 (4.53%)	0/15 (0.00%)	9/268 (3.36%)	1/17 (5.88%)	0/1 (0.00%)
Injury, poisoning and procedural complications
Fall ^† 1	5/287 (1.74%)	1/15 (6.67%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Meniscus injury ^† 1	0/287 (0.00%)	1/15 (6.67%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Investigations
Alanine aminotransferase increased ^† 1	20/287 (6.97%)	1/15 (6.67%)	6/268 (2.24%)	0/17 (0.00%)	0/1 (0.00%)
Aspartate aminotransferase increased ^† 1	14/287 (4.88%)	1/15 (6.67%)	3/268 (1.12%)	0/17 (0.00%)	0/1 (0.00%)
Neutrophil count decreased ^† 1	2/287 (0.70%)	0/15 (0.00%)	18/268 (6.72%)	0/17 (0.00%)	0/1 (0.00%)
Weight decreased ^† 1	28/287 (9.76%)	0/15 (0.00%)	21/268 (7.84%)	1/17 (5.88%)	0/1 (0.00%)
White blood cell count decreased ^† 1	1/287 (0.35%)	0/15 (0.00%)	22/268 (8.21%)	0/17 (0.00%)	0/1 (0.00%)
Amylase increased ^† 1	0/287 (0.00%)	1/15 (6.67%)	1/268 (0.37%)	1/17 (5.88%)	0/1 (0.00%)
Blood alkaline phosphatase increased ^† 1	7/287 (2.44%)	1/15 (6.67%)	6/268 (2.24%)	0/17 (0.00%)	0/1 (0.00%)
Blood creatinine increased ^† 1	11/287 (3.83%)	0/15 (0.00%)	4/268 (1.49%)	1/17 (5.88%)	0/1 (0.00%)
Blood glucose increased ^† 1	2/287 (0.70%)	1/15 (6.67%)	6/268 (2.24%)	0/17 (0.00%)	0/1 (0.00%)
Blood magnesium decreased ^† 1	1/287 (0.35%)	0/15 (0.00%)	1/268 (0.37%)	1/17 (5.88%)	0/1 (0.00%)
Haemoglobin decreased ^† 1	5/287 (1.74%)	1/15 (6.67%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Lipase increased ^† 1	0/287 (0.00%)	1/15 (6.67%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Weight increased ^† 1	11/287 (3.83%)	0/15 (0.00%)	5/268 (1.87%)	1/17 (5.88%)	0/1 (0.00%)
Metabolism and nutrition disorders
Decreased appetite ^† 1	91/287 (31.71%)	0/15 (0.00%)	64/268 (23.88%)	0/17 (0.00%)	1/1 (100.00%)
Hyperglycaemia ^† 1	15/287 (5.23%)	0/15 (0.00%)	15/268 (5.60%)	0/17 (0.00%)	0/1 (0.00%)
Hypercholesterolaemia ^† 1	1/287 (0.35%)	1/15 (6.67%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Hypertriglyceridaemia ^† 1	1/287 (0.35%)	1/15 (6.67%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Hypocalcaemia ^† 1	1/287 (0.35%)	1/15 (6.67%)	6/268 (2.24%)	0/17 (0.00%)	0/1 (0.00%)
Hypomagnesaemia ^† 1	9/287 (3.14%)	1/15 (6.67%)	7/268 (2.61%)	0/17 (0.00%)	0/1 (0.00%)
Hyponatraemia ^† 1	10/287 (3.48%)	1/15 (6.67%)	4/268 (1.49%)	0/17 (0.00%)	0/1 (0.00%)
Hypophosphataemia ^† 1	5/287 (1.74%)	1/15 (6.67%)	3/268 (1.12%)	0/17 (0.00%)	0/1 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	72/287 (25.09%)	3/15 (20.00%)	41/268 (15.30%)	1/17 (5.88%)	0/1 (0.00%)
Back pain ^† 1	45/287 (15.68%)	2/15 (13.33%)	18/268 (6.72%)	0/17 (0.00%)	0/1 (0.00%)
Musculoskeletal chest pain ^† 1	18/287 (6.27%)	0/15 (0.00%)	14/268 (5.22%)	0/17 (0.00%)	0/1 (0.00%)
Musculoskeletal pain ^† 1	15/287 (5.23%)	0/15 (0.00%)	8/268 (2.99%)	0/17 (0.00%)	0/1 (0.00%)
Myalgia ^† 1	20/287 (6.97%)	2/15 (13.33%)	35/268 (13.06%)	0/17 (0.00%)	0/1 (0.00%)
Pain in extremity ^† 1	29/287 (10.10%)	1/15 (6.67%)	30/268 (11.19%)	1/17 (5.88%)	0/1 (0.00%)
Muscle tightness ^† 1	1/287 (0.35%)	1/15 (6.67%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Muscular weakness ^† 1	11/287 (3.83%)	1/15 (6.67%)	6/268 (2.24%)	0/17 (0.00%)	0/1 (0.00%)
Musculoskeletal discomfort ^† 1	2/287 (0.70%)	1/15 (6.67%)	2/268 (0.75%)	0/17 (0.00%)	0/1 (0.00%)
Musculoskeletal stiffness ^† 1	2/287 (0.70%)	1/15 (6.67%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Neck pain ^† 1	8/287 (2.79%)	1/15 (6.67%)	4/268 (1.49%)	0/17 (0.00%)	0/1 (0.00%)
Pain in jaw ^† 1	3/287 (1.05%)	0/15 (0.00%)	1/268 (0.37%)	1/17 (5.88%)	0/1 (0.00%)
Nervous system disorders
Dizziness ^† 1	30/287 (10.45%)	1/15 (6.67%)	25/268 (9.33%)	1/17 (5.88%)	0/1 (0.00%)
Dysgeusia ^† 1	6/287 (2.09%)	0/15 (0.00%)	20/268 (7.46%)	0/17 (0.00%)	1/1 (100.00%)
Headache ^† 1	33/287 (11.50%)	1/15 (6.67%)	35/268 (13.06%)	1/17 (5.88%)	0/1 (0.00%)
Neuropathy peripheral ^† 1	12/287 (4.18%)	0/15 (0.00%)	28/268 (10.45%)	2/17 (11.76%)	0/1 (0.00%)
Paraesthesia ^† 1	14/287 (4.88%)	0/15 (0.00%)	25/268 (9.33%)	0/17 (0.00%)	0/1 (0.00%)
Peripheral sensory neuropathy ^† 1	7/287 (2.44%)	0/15 (0.00%)	14/268 (5.22%)	1/17 (5.88%)	0/1 (0.00%)
Cognitive disorder ^† 1	0/287 (0.00%)	1/15 (6.67%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Epilepsy ^† 1	0/287 (0.00%)	0/15 (0.00%)	0/268 (0.00%)	0/17 (0.00%)	1/1 (100.00%)
Hypoaesthesia ^† 1	12/287 (4.18%)	1/15 (6.67%)	4/268 (1.49%)	0/17 (0.00%)	0/1 (0.00%)
Memory impairment ^† 1	2/287 (0.70%)	1/15 (6.67%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Motor dysfunction ^† 1	1/287 (0.35%)	1/15 (6.67%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Transient ischaemic attack ^† 1	0/287 (0.00%)	1/15 (6.67%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Psychiatric disorders
Anxiety ^† 1	18/287 (6.27%)	0/15 (0.00%)	8/268 (2.99%)	0/17 (0.00%)	0/1 (0.00%)
Insomnia ^† 1	25/287 (8.71%)	2/15 (13.33%)	23/268 (8.58%)	1/17 (5.88%)	0/1 (0.00%)
Confusional state ^† 1	10/287 (3.48%)	1/15 (6.67%)	5/268 (1.87%)	0/17 (0.00%)	0/1 (0.00%)
Depression ^† 1	8/287 (2.79%)	0/15 (0.00%)	10/268 (3.73%)	1/17 (5.88%)	0/1 (0.00%)
Reproductive system and breast disorders
Breast pain ^† 1	2/287 (0.70%)	1/15 (6.67%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	83/287 (28.92%)	5/15 (33.33%)	67/268 (25.00%)	6/17 (35.29%)	1/1 (100.00%)
Dyspnoea ^† 1	68/287 (23.69%)	1/15 (6.67%)	64/268 (23.88%)	6/17 (35.29%)	1/1 (100.00%)
Dyspnoea exertional ^† 1	11/287 (3.83%)	0/15 (0.00%)	19/268 (7.09%)	1/17 (5.88%)	0/1 (0.00%)
Haemoptysis ^† 1	16/287 (5.57%)	0/15 (0.00%)	15/268 (5.60%)	1/17 (5.88%)	0/1 (0.00%)
Nasal congestion ^† 1	14/287 (4.88%)	1/15 (6.67%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Oropharyngeal pain ^† 1	12/287 (4.18%)	1/15 (6.67%)	16/268 (5.97%)	0/17 (0.00%)	0/1 (0.00%)
Productive cough ^† 1	16/287 (5.57%)	1/15 (6.67%)	10/268 (3.73%)	1/17 (5.88%)	0/1 (0.00%)
Pneumonitis ^† 1	7/287 (2.44%)	0/15 (0.00%)	2/268 (0.75%)	1/17 (5.88%)	0/1 (0.00%)
Pulmonary embolism ^† 1	4/287 (1.39%)	0/15 (0.00%)	4/268 (1.49%)	1/17 (5.88%)	0/1 (0.00%)
Rhinitis allergic ^† 1	4/287 (1.39%)	0/15 (0.00%)	2/268 (0.75%)	1/17 (5.88%)	0/1 (0.00%)
Sputum discoloured ^† 1	1/287 (0.35%)	0/15 (0.00%)	1/268 (0.37%)	1/17 (5.88%)	0/1 (0.00%)
Skin and subcutaneous tissue disorders
Alopecia ^† 1	11/287 (3.83%)	0/15 (0.00%)	70/268 (26.12%)	0/17 (0.00%)	0/1 (0.00%)
Dry skin ^† 1	24/287 (8.36%)	0/15 (0.00%)	9/268 (3.36%)	0/17 (0.00%)	0/1 (0.00%)
Erythema ^† 1	7/287 (2.44%)	1/15 (6.67%)	18/268 (6.72%)	0/17 (0.00%)	0/1 (0.00%)
Pruritus ^† 1	37/287 (12.89%)	1/15 (6.67%)	7/268 (2.61%)	2/17 (11.76%)	0/1 (0.00%)
Rash ^† 1	41/287 (14.29%)	3/15 (20.00%)	18/268 (6.72%)	2/17 (11.76%)	0/1 (0.00%)
Night sweats ^† 1	9/287 (3.14%)	1/15 (6.67%)	5/268 (1.87%)	0/17 (0.00%)	0/1 (0.00%)
Toxic skin eruption ^† 1	0/287 (0.00%)	0/15 (0.00%)	1/268 (0.37%)	0/17 (0.00%)	1/1 (100.00%)
Vascular disorders
Hypertension ^† 1	14/287 (4.88%)	2/15 (13.33%)	4/268 (1.49%)	0/17 (0.00%)	0/1 (0.00%)
Haematoma ^† 1	1/287 (0.35%)	1/15 (6.67%)	0/268 (0.00%)	0/17 (0.00%)	0/1 (0.00%)
Hot flush ^† 1	7/287 (2.44%)	1/15 (6.67%)	1/268 (0.37%)	0/17 (0.00%)	0/1 (0.00%)
Hypotension ^† 1	12/287 (4.18%)	1/15 (6.67%)	9/268 (3.36%)	0/17 (0.00%)	0/1 (0.00%)
1 Term from vocabulary, 24.1 † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

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

Layout table for Results Point of Contact information

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):

Borghaei H, Gettinger S, Vokes EE, Chow LQM, Burgio MA, de Castro Carpeno J, Pluzanski A, Arrieta O, Frontera OA, Chiari R, Butts C, Wojcik-Tomaszewska J, Coudert B, Garassino MC, Ready N, Felip E, Garcia MA, Waterhouse D, Domine M, Barlesi F, Antonia S, Wohlleber M, Gerber DE, Czyzewicz G, Spigel DR, Crino L, Eberhardt WEE, Li A, Marimuthu S, Brahmer J. Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer. J Clin Oncol. 2021 Mar 1;39(7):723-733. doi: 10.1200/JCO.20.01605. Epub 2021 Jan 15. Erratum In: J Clin Oncol. 2021 Apr 1;39(10):1190.

Long GV, Tykodi SS, Schneider JG, Garbe C, Gravis G, Rashford M, Agrawal S, Grigoryeva E, Bello A, Roy A, Rollin L, Zhao X. Assessment of nivolumab exposure and clinical safety of 480 mg every 4 weeks flat-dosing schedule in patients with cancer. Ann Oncol. 2018 Nov 1;29(11):2208-2213. doi: 10.1093/annonc/mdy408.

Reck M, Brahmer J, Bennett B, Taylor F, Penrod JR, DeRosa M, Dastani H, Spigel DR, Gralla RJ. Evaluation of health-related quality of life and symptoms in patients with advanced non-squamous non-small cell lung cancer treated with nivolumab or docetaxel in CheckMate 057. Eur J Cancer. 2018 Oct;102:23-30. doi: 10.1016/j.ejca.2018.05.005. Epub 2018 Aug 10.

Vokes EE, Ready N, Felip E, Horn L, Burgio MA, Antonia SJ, Aren Frontera O, Gettinger S, Holgado E, Spigel D, Waterhouse D, Domine M, Garassino M, Chow LQM, Blumenschein G Jr, Barlesi F, Coudert B, Gainor J, Arrieta O, Brahmer J, Butts C, Steins M, Geese WJ, Li A, Healey D, Crino L. Nivolumab versus docetaxel in previously treated advanced non-small-cell lung cancer (CheckMate 017 and CheckMate 057): 3-year update and outcomes in patients with liver metastases. Ann Oncol. 2018 Apr 1;29(4):959-965. doi: 10.1093/annonc/mdy041.

Horn L, Spigel DR, Vokes EE, Holgado E, Ready N, Steins M, Poddubskaya E, Borghaei H, Felip E, Paz-Ares L, Pluzanski A, Reckamp KL, Burgio MA, Kohlhaeufl M, Waterhouse D, Barlesi F, Antonia S, Arrieta O, Fayette J, Crino L, Rizvi N, Reck M, Hellmann MD, Geese WJ, Li A, Blackwood-Chirchir A, Healey D, Brahmer J, Eberhardt WEE. Nivolumab Versus Docetaxel in Previously Treated Patients With Advanced Non-Small-Cell Lung Cancer: Two-Year Outcomes From Two Randomized, Open-Label, Phase III Trials (CheckMate 017 and CheckMate 057). J Clin Oncol. 2017 Dec 10;35(35):3924-3933. doi: 10.1200/JCO.2017.74.3062. Epub 2017 Oct 12.

Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, Chow LQ, Vokes EE, Felip E, Holgado E, Barlesi F, Kohlhaufl M, Arrieta O, Burgio MA, Fayette J, Lena H, Poddubskaya E, Gerber DE, Gettinger SN, Rudin CM, Rizvi N, Crino L, Blumenschein GR Jr, Antonia SJ, Dorange C, Harbison CT, Graf Finckenstein F, Brahmer JR. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Oct 22;373(17):1627-39. doi: 10.1056/NEJMoa1507643. Epub 2015 Sep 27.

Layout table for additonal information

Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT01673867
Other Study ID Numbers:	CA209-057 2012-002472-14 ( EudraCT Number )
First Submitted:	August 24, 2012
First Posted:	August 28, 2012
Results First Submitted:	January 29, 2016
Results First Posted:	February 26, 2016
Last Update Posted:	February 8, 2023

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