Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) (CheckMate 017)
CompletedPhase 3Results postedLast updated 28 December 2022
What this trial tests
Phase 3 trial testing Nivolumab in Squamous Cell Non-small Cell Lung Cancer in 272 participants. Completed in 16 August 2021.
18 and older, any sex, with Squamous Cell Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Survival (OS) Time in Months for All Randomized Participants at Primary EndpointPrimary· Randomization until 199 deaths, up to November 2014, approximately 25 months
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.
Group
Value
95% CI
Nivolumab
9.23
7.33 – 13.27
Docetaxel
6.01
5.13 – 7.33
Overall Survival (OS) Rate in All Randomized ParticipantsPrimary· Randomization to 18 months post-randomization, up to June 2015
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.
6 months
Group
Value
95% CI
Nivolumab
63.7
55.0 – 71.2
Docetaxel
50.7
42.1 – 58.8
12 months
Group
Value
95% CI
Nivolumab
42.2
33.8 – 50.4
Docetaxel
24.3
17.4 – 31.7
18 months
Group
Value
95% CI
Nivolumab
28.1
20.8 – 35.8
Docetaxel
12.5
7.6 – 18.7
Number of Deaths From Any Cause in All Randomized Participants at Primary EndpointPrimary· Randomization until 199 deaths, up to November 2014, approximately 25 months
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.
Group
Value
95% CI
Nivolumab
86
Docetaxel
113
Objective Response Rate (ORR) in All Randomized ParticipantsSecondary· From the date of randomization up to the date of objectively documented progression, up to approximately 103 months
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 = D
Group
Value
95% CI
Nivolumab
20.0
13.6 – 27.7
Docetaxel
8.8
4.6 – 14.8
Time To Response (TTR) in Months for All Confirmed RespondersSecondary· From the date of randomization to the date of the first confirmed response, up to approximately 12 months
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.
Group
Value
95% CI
Nivolumab
2.23
1.6 – 11.8
Docetaxel
2.09
1.8 – 9.5
Duration of Objective Response (DOR) in Months for All Confirmed RespondersSecondary· 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
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. Part
Group
Value
95% CI
Nivolumab
24.51
9.76 – 69.65
Docetaxel
8.41
3.58 – 14.03
Progression Free Survival Rate (PFSR)Secondary· From randomization to specified timepoints, up to 84 months
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 p
6 months
Group
Value
95% CI
Nivolumab
38.4
30.0 – 46.8
Docetaxel
22.6
15.7 – 30.2
12 months
Group
Value
95% CI
Nivolumab
21.0
14.3 – 28.6
Docetaxel
7.2
3.4 – 12.8
18 months
Group
Value
95% CI
Nivolumab
15.87
9.9 – 22.8
Docetaxel
1.8
0.4 – 5.7
24 months
Group
Value
95% CI
Nivolumab
14.8
9.1 – 21.8
Docetaxel
NA
NA – NA
36 months
Group
Value
95% CI
Nivolumab
11.0
6.1 – 17.5
Docetaxel
NA
NA – NA
48 months
Group
Value
95% CI
Nivolumab
8.9
4.5 – 15.1
Docetaxel
NA
NA – NA
60 months
Group
Value
95% CI
Nivolumab
8.9
4.5 – 15.1
Docetaxel
NA
NA – NA
72 months
Group
Value
95% CI
Nivolumab
7.6
3.5 – 13.7
Docetaxel
NA
NA – NA
Progression-Free Survival (PFS) Time in Months for All Randomized ParticipantsSecondary· 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
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). Participant
Group
Value
95% CI
Nivolumab
3.48
2.14 – 5.06
Docetaxel
2.83
2.10 – 3.52
Percentage of Participants Experiencing Disease-related Symptom Improvement by Week 12Secondary· From randomization up to Week 12
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 representin
Group
Value
95% CI
Nivolumab
18.5
12.4 – 26.1
Docetaxel
21.2
14.7 – 29.0
Overall Survival (OS) Time in Months by Baseline PD-L1 Expression for All Randomized ParticipantsSecondary· From the date of randomization to the date of death from any cause, up to approximately 103 months
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.
PD-L1 expression >= 5%
Group
Value
95% CI
Nivolumab
9.95
5.82 – 16.69
Docetaxel
6.37
4.50 – 9.03
PD-L1 expression < 5%
Group
Value
95% CI
Nivolumab
8.54
5.49 – 12.62
Docetaxel
6.14
5.13 – 8.28
PD-L1 not quantifiable at baseline
Group
Value
95% CI
Nivolumab
9.41
7.10 – 25.20
Docetaxel
5.06
3.02 – 6.11
Objective Response Rate (ORR) by Baseline PD-L1 Expression for All Randomized ParticipantsSecondary· From the date of randomization up to the date of objectively documented progression, up to approximately 103 months
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.;
PD-L1 expression >= 5%
Group
Value
95% CI
Nivolumab
21.4
10.3 – 36.8
Docetaxel
7.7
1.6 – 20.9
PD-L1 expression < 5%
Group
Value
95% CI
Nivolumab
14.7
7.6 – 24.7
Docetaxel
11.6
5.1 – 21.6
PD-L1 not quantifiable at baseline
Group
Value
95% CI
Nivolumab
38.9
17.3 – 64.3
Docetaxel
3.4
0.1 – 17.8
Progression Free Survival (PFS) Time in Months by Baseline PD-L1 Expression for All Randomized ParticipantsSecondary· 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
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 l
PD-L1 expression >= 5%
Group
Value
95% CI
Nivolumab
5.06
2.10 – 7.56
Docetaxel
3.06
1.94 – 4.63
PD-L1 expression < 5%
Group
Value
95% CI
Nivolumab
2.23
1.94 – 4.73
Docetaxel
2.92
2.07 – 3.58
PD-L1 not quantifiable at baseline
Group
Value
95% CI
Nivolumab
5.39
2.10 – 10.45
Docetaxel
2.23
2.04 – 4.40
Adverse events — posted to ClinicalTrials.gov
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)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Nivolumab 3 mg/kg
Serious: 85/131 (65%)
Deaths: 119/135
Nivolumab 480 mg
Serious: 1/6 (17%)
Deaths: 2/6
Docetaxel
Serious: 92/129 (71%)
Deaths: 129/137
Extension Phase of Docetaxel Arm: Nivolumab 3 mg/kg
Serious: 4/6 (67%)
Deaths: 5/6
Extension Phase of Docetaxel Arm: Nivolumab 480 mg
Serious: 0/1 (0%)
Deaths: 1/1
Serious adverse events (119 terms)
Reaction
System
Nivolumab 3 mg/kg
Nivolumab 480 mg
Docetaxel
Extension Phase of Docetax…
Extension Phase of Docetax…
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of the study is to compare the overall survival of BMS-936558 as compared with Docetaxel in subjects with squamous cell non-small cell lung cancer (NSCLC), after failure of prior platinum-based chemotherapy.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem
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NCT07444619 — A Phase I Study of Pazopanib in Combination With Trabectedin, Ipilimumab and Nivolumab (TraPIN) in Pediatric and Young A
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NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
· Phase 3
· not yet recruiting
NCT07420439 — Treatment in Patients With Advanced Non-Small Cell Lung Carcinoma and Interstitial Lung Disease
· Phase 2
· not yet recruiting
NCT07510334 — VSV-IFNβ-NIS With Ipilimumab and Nivolumab for the Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma
· Phase 2
· not yet recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
Last refreshed: 28 December 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01642004.