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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)

Primary Purpose

Squamous Cell Non-small Cell Lung Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Nivolumab

Docetaxel

About this trial

This is an interventional treatment trial for Squamous Cell Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Men and women ≥18 years of age
Subjects with histologically or cytologically-documented squamous cell NSCLC who present with Stage IIIB/IV disease or with recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection or definitive chemoradiation therapy for locally advanced disease)
Disease recurrence or progression during/after one prior platinum doublet-based chemotherapy regimen for advanced or metastatic disease
Measurable disease by computed tomography (CT)/Magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Eastern Cooperative Oncology Group (ECOG) performance status ≤1
A formalin fixed, paraffin-embedded (FFPE) tumor tissue block or unstained slides of tumor sample (archival or recent) must be available for biomarker evaluation. Specimens must be received by the central lab prior to randomization. Biopsy should be excisional, incisional or core needle. Fine needle aspiration is insufficient

Exclusion Criteria:

Subjects with untreated central nervous system (CNS) metastases are excluded. Subjects are eligible if CNS metastases are treated and subjects are neurologically returned to baseline for at least 2 weeks prior to enrollment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent)
Subjects with carcinomatous meningitis
Subjects with active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization
Prior therapy with anti-Programmed death-1 (PD-1), anti-Programmed cell death ligand 1 (PD-L1), anti-Programmed cell death ligand 2 (PD-L2), anti-CD137, or anti-Cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
Prior treatment on the first line study CA184104 first line NSCLC study
Prior treatment with Docetaxel
Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
Treatment with any investigational agent within 14 days of first administration of study treatment

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm A: Nivolumab

Arm B: Docetaxel

Arm Description

Nivolumab 3 mg/kg solution intravenously (IV) 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 75 mg/m^2 concentrate for solution for intravenous infusion every 3 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.

Outcomes

Primary Outcome Measures

Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint

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.

Overall Survival (OS) Rate in All Randomized Participants

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.

Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint

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.

Secondary Outcome Measures

Objective Response Rate (ORR) in All Randomized Participants

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 To Response (TTR) in Months for All Confirmed Responders

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.

Duration of Objective Response (DOR) in Months for All Confirmed Responders

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.

Progression Free Survival Rate (PFSR)

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.

Progression-Free Survival (PFS) Time in Months for All Randomized Participants

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.

Percentage of Participants Experiencing Disease-related Symptom Improvement by 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 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.

Overall Survival (OS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants

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.

Objective Response Rate (ORR) by Baseline PD-L1 Expression for All Randomized Participants

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.

Progression Free Survival (PFS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants

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.

Full Information

NCT ID

NCT01642004

First Posted

July 9, 2012

Last Updated

November 22, 2022

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT01642004

Brief Title

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

Official Title

An Open-Label Randomized Phase III Trial of BMS-936558 (Nivolumab) Versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

October 16, 2012 (Actual)

Primary Completion Date

November 17, 2014 (Actual)

Study Completion Date

August 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Squamous Cell Non-small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

272 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A: Nivolumab

Arm Type

Experimental

Arm Description

Arm Title

Arm B: Docetaxel

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Nivolumab

Other Intervention Name(s)

BMS-936558

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Other Intervention Name(s)

Taxotere®

Primary Outcome Measure Information:

Title

Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint

Description

Time Frame

Randomization until 199 deaths, up to November 2014, approximately 25 months

Title

Overall Survival (OS) Rate in All Randomized Participants

Description

Time Frame

Randomization to 18 months post-randomization, up to June 2015

Title

Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint

Description

Time Frame

Randomization until 199 deaths, up to November 2014, approximately 25 months

Secondary Outcome Measure Information:

Title

Objective Response Rate (ORR) in All Randomized Participants

Description

Time Frame

From the date of randomization up to the date of objectively documented progression, up to approximately 103 months

Title

Time To Response (TTR) in Months for All Confirmed Responders

Description

Time Frame

From the date of randomization to the date of the first confirmed response, up to approximately 12 months

Title

Duration of Objective Response (DOR) in Months for All Confirmed Responders

Description

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

Title

Progression Free Survival Rate (PFSR)

Description

Time Frame

From randomization to specified timepoints, up to 84 months

Title

Progression-Free Survival (PFS) Time in Months for All Randomized Participants

Description

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

Title

Percentage of Participants Experiencing Disease-related Symptom Improvement by Week 12

Description

Time Frame

From randomization up to Week 12

Title

Overall Survival (OS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants

Description

Time Frame

From the date of randomization to the date of death from any cause, up to approximately 103 months

Title

Objective Response Rate (ORR) by Baseline PD-L1 Expression for All Randomized Participants

Description

Time Frame

From the date of randomization up to the date of objectively documented progression, up to approximately 103 months

Title

Progression Free Survival (PFS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men and women ≥18 years of age Subjects with histologically or cytologically-documented squamous cell NSCLC who present with Stage IIIB/IV disease or with recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection or definitive chemoradiation therapy for locally advanced disease) Disease recurrence or progression during/after one prior platinum doublet-based chemotherapy regimen for advanced or metastatic disease Measurable disease by computed tomography (CT)/Magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria Eastern Cooperative Oncology Group (ECOG) performance status ≤1 A formalin fixed, paraffin-embedded (FFPE) tumor tissue block or unstained slides of tumor sample (archival or recent) must be available for biomarker evaluation. Specimens must be received by the central lab prior to randomization. Biopsy should be excisional, incisional or core needle. Fine needle aspiration is insufficient Exclusion Criteria: Subjects with untreated central nervous system (CNS) metastases are excluded. Subjects are eligible if CNS metastases are treated and subjects are neurologically returned to baseline for at least 2 weeks prior to enrollment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent) Subjects with carcinomatous meningitis Subjects with active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization Prior therapy with anti-Programmed death-1 (PD-1), anti-Programmed cell death ligand 1 (PD-L1), anti-Programmed cell death ligand 2 (PD-L2), anti-CD137, or anti-Cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways) Prior treatment on the first line study CA184104 first line NSCLC study Prior treatment with Docetaxel Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity Treatment with any investigational agent within 14 days of first administration of study treatment

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Mayo Clinic in Arizona - Scottsdale

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85259

Country

United States

Facility Name

City Of Hope

City

Duarte

State/Province

California

ZIP/Postal Code

91010-3000

Country

United States

Facility Name

Local Institution - 0020

City

Duarte

State/Province

California

ZIP/Postal Code

91010-3000

Country

United States

Facility Name

Local Institution - 0009

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

Facility Name

Yale University

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

Facility Name

H. Lee Moffitt Cancer Center

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Local Institution - 0004

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Local Institution - 0153

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

Local Institution - 0100

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

Local Institution - 0003

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

Local Institution - 0036

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Local Institution - 0084

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Local Institution - 0150

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Local Institution - 0016

City

Mineola

State/Province

New York

ZIP/Postal Code

11501

Country

United States

Facility Name

Winthrop University Hospital

City

Mineola

State/Province

New York

ZIP/Postal Code

11501

Country

United States

Facility Name

Columbia University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Local Institution - 0006

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Memorial Sloan Kettering Nassau

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Local Institution - 0008

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Oncology Hematology Care, Inc.

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

St Mary Medical Center

City

Langhorne

State/Province

Pennsylvania

ZIP/Postal Code

19047

Country

United States

Facility Name

Fox Chase Cancer Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19111

Country

United States

Facility Name

Local Institution - 0011

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19111

Country

United States

Facility Name

Guthrie Medical Group, Pc

City

Sayre

State/Province

Pennsylvania

ZIP/Postal Code

18840

Country

United States

Facility Name

Local Institution - 0082

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29210

Country

United States

Facility Name

Local Institution - 0087

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404

Country

United States

Facility Name

Local Institution - 0005

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Tennessee Oncology, PLLC

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Local Institution - 0032

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

Local Institution - 0012

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

University Of Texas Southwestern Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

Local Institution - 0086

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Local Institution - 0017

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

Swedish Cancer Institute

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

Local Institution - 0001

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Name

University of Washington - Seattle Cancer Care Alliance

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Name

Local Institution - 0033

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26506-9162

Country

United States

Facility Name

Local Institution - 0116

City

Capital Federal

State/Province

Buenos Aires

ZIP/Postal Code

1431

Country

Argentina

Facility Name

Local Institution - 0072

City

Ciudad Autónoma De Buenos Aire

State/Province

Buenos Aires

ZIP/Postal Code

CP1426ANZ

Country

Argentina

Facility Name

Local Institution - 0164

City

San Miguel De Tucuman

State/Province

Tucuman

ZIP/Postal Code

CPT4000IAK

Country

Argentina

Facility Name

Local Institution - 0071

City

Buenos Aires

ZIP/Postal Code

C1280AEB

Country

Argentina

Facility Name

Local Institution - 0141

City

Cordoba

ZIP/Postal Code

X5002AOQ

Country

Argentina

Facility Name

Local Institution - 0073

City

Wollongong

State/Province

New South Wales

ZIP/Postal Code

2500

Country

Australia

Facility Name

Local Institution - 0159

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

Local Institution - 0140

City

Elizabeth Vale

State/Province

South Australia

ZIP/Postal Code

5112

Country

Australia

Facility Name

Local Institution - 0158

City

Kurralta Park

State/Province

South Australia

ZIP/Postal Code

5037

Country

Australia

Facility Name

Local Institution - 0085

City

Clayton

State/Province

Victoria

ZIP/Postal Code

3168

Country

Australia

Facility Name

Local Institution - 0102

City

Linz

ZIP/Postal Code

4020

Country

Austria

Facility Name

Local Institution - 0104

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Local Institution - 0049

City

Vienna

ZIP/Postal Code

1130

Country

Austria

Facility Name

Local Institution - 0103

City

Wels

ZIP/Postal Code

4600

Country

Austria

Facility Name

Local Institution - 0146

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3E 0V9

Country

Canada

Facility Name

Local Institution - 0147

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Facility Name

Local Institution - 0152

City

Rimouski

State/Province

Quebec

ZIP/Postal Code

G5L 5T1

Country

Canada

Facility Name

Local Institution - 0117

City

Santiago

State/Province

Metropolitana

ZIP/Postal Code

7600448

Country

Chile

Facility Name

Local Institution - 0131

City

Santiago

State/Province

Metropolitana

ZIP/Postal Code

8420383

Country

Chile

Facility Name

Local Institution - 0110

City

Viña Del Mar

State/Province

Valparaiso

Country

Chile

Facility Name

Local Institution - 0161

City

Antofagasta

ZIP/Postal Code

240000

Country

Chile

Facility Name

Local Institution - 0154

City

Santiago

ZIP/Postal Code

7630370

Country

Chile

Facility Name

Local Institution - 0111

City

Praha 8

ZIP/Postal Code

180 81

Country

Czechia

Facility Name

Local Institution - 0053

City

Avignon Cedes 9

ZIP/Postal Code

84918

Country

France

Facility Name

Local Institution - 0156

City

Caen

ZIP/Postal Code

14000

Country

France

Facility Name

Local Institution - 0025

City

Dijon

ZIP/Postal Code

21000

Country

France

Facility Name

Local Institution

City

Dijon

ZIP/Postal Code

21000

Country

France

Facility Name

Local Institution - 0093

City

La Roche Sur Yon Cedex 9

ZIP/Postal Code

85925

Country

France

Facility Name

Local Institution - 0022

City

Lyon Cedex 08

ZIP/Postal Code

69373

Country

France

Facility Name

Local Institution

City

Lyon Cedex 08

ZIP/Postal Code

69373

Country

France

Facility Name

Local Institution - 0023

City

Marseille Cedex 20

ZIP/Postal Code

13915

Country

France

Facility Name

Local Institution

City

Marseille Cedex 20

ZIP/Postal Code

13915

Country

France

Facility Name

Local Institution - 0160

City

Pierre Benite

ZIP/Postal Code

69495

Country

France

Facility Name

Local Institution - 0027

City

Rennes Cedex 9

ZIP/Postal Code

35033

Country

France

Facility Name

Local Institution

City

Rennes Cedex 9

ZIP/Postal Code

35033

Country

France

Facility Name

Local Institution - 0157

City

Strasbourg

ZIP/Postal Code

67090

Country

France

Facility Name

Local Institution - 0040

City

Toulouse

ZIP/Postal Code

31300

Country

France

Facility Name

Local Institution - 0064

City

Bad Berka

ZIP/Postal Code

99437

Country

Germany

Facility Name

Local Institution - 0105

City

Essen

ZIP/Postal Code

45122

Country

Germany

Facility Name

Local Institution - 0109

City

Gerlingen

ZIP/Postal Code

70839

Country

Germany

Facility Name

Local Institution - 0048

City

Grosshansdorf

ZIP/Postal Code

22927

Country

Germany

Facility Name

Local Institution - 0065

City

Heidelberg

ZIP/Postal Code

69126

Country

Germany

Facility Name

Local Institution - 0063

City

Koeln

ZIP/Postal Code

51109

Country

Germany

Facility Name

Local Institution - 0162

City

Krefeld

ZIP/Postal Code

47805

Country

Germany

Facility Name

Local Institution - 0095

City

Budapest

ZIP/Postal Code

H-1121

Country

Hungary

Facility Name

Local Institution - 0096

City

Budapest

ZIP/Postal Code

H-1121

Country

Hungary

Facility Name

Local Institution - 0039

City

Dublin 8

State/Province

Dublin

Country

Ireland

Facility Name

Local Institution - 0035

City

Dublin 9

State/Province

Dublin

Country

Ireland

Facility Name

Local Institution - 0058

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Local Institution - 0088

City

Meldola (fc)

ZIP/Postal Code

47014

Country

Italy

Facility Name

Local Institution - 0057

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Local Institution - 0056

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

Local Institution - 0055

City

Perugia

ZIP/Postal Code

06132

Country

Italy

Facility Name

Local Institution - 0089

City

Ravenna

ZIP/Postal Code

48121

Country

Italy

Facility Name

Local Institution - 0054

City

Siena

ZIP/Postal Code

53100

Country

Italy

Facility Name

Local Institution - 0107

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

06735

Country

Mexico

Facility Name

Local Institution - 0108

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

14080

Country

Mexico

Facility Name

Local Institution - 0106

City

Leon, Guanajato

State/Province

Guanajuato

ZIP/Postal Code

37000

Country

Mexico

Facility Name

Local Institution - 0139

City

Hermosillo

State/Province

Sonora

ZIP/Postal Code

83280

Country

Mexico

Facility Name

Local Institution - 0052

City

Amsterdam

ZIP/Postal Code

1066 CX

Country

Netherlands

Facility Name

Local Institution - 0051

City

Rotterdam

ZIP/Postal Code

3000 CA

Country

Netherlands

Facility Name

Local Institution - 0143

City

Oslo

ZIP/Postal Code

0310

Country

Norway

Facility Name

Local Institution - 0099

City

Arequipa

ZIP/Postal Code

Country

Peru

Facility Name

Local Institution - 0061

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Local Institution - 0126

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

Local Institution - 0130

City

Krakow

ZIP/Postal Code

31-202

Country

Poland

Facility Name

Local Institution - 0129

City

Olsztyn

ZIP/Postal Code

10-513

Country

Poland

Facility Name

Local Institution - 0124

City

Szczecin

ZIP/Postal Code

70-891

Country

Poland

Facility Name

Local Institution - 0127

City

Warszawa

ZIP/Postal Code

02-781

Country

Poland

Facility Name

Local Institution - 0136

City

Bucuresti

ZIP/Postal Code

010976

Country

Romania

Facility Name

Local Institution - 0145

City

Cluj-Napoca

ZIP/Postal Code

400352

Country

Romania

Facility Name

Local Institution - 0138

City

Constanta

ZIP/Postal Code

900591

Country

Romania

Facility Name

Local Institution - 0121

City

Craiova

ZIP/Postal Code

200385

Country

Romania

Facility Name

Local Institution - 0119

City

Iasi

ZIP/Postal Code

700106

Country

Romania

Facility Name

Local Institution - 0120

City

Timisoara

ZIP/Postal Code

300167

Country

Romania

Facility Name

Local Institution - 0132

City

Moscow

ZIP/Postal Code

115 478

Country

Russian Federation

Facility Name

Local Institution - 0133

City

Moscow

ZIP/Postal Code

115 478

Country

Russian Federation

Facility Name

Local Institution - 0144

City

Moscow

ZIP/Postal Code

115 478

Country

Russian Federation

Facility Name

Local Institution - 0135

City

St. Petersburg

ZIP/Postal Code

198255

Country

Russian Federation

Facility Name

Local Institution - 0044

City

Barakaldo

State/Province

Vizcaya

ZIP/Postal Code

48903

Country

Spain

Facility Name

Local Institution - 0042

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Local Institution - 0046

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Local Institution - 0045

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Facility Name

Local Institution - 0041

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Local Institution - 0047

City

Cottingham

State/Province

East Yorkshire

ZIP/Postal Code

HU16 5JQ

Country

United Kingdom

Facility Name

Local Institution - 0034

City

Southampton

State/Province

Hampshire

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Facility Name

Local Institution - 0163

City

Withington

State/Province

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

Local Institution - 0037

City

Sheffield

State/Province

Yorkshire

ZIP/Postal Code

S10 2SJ

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

33449799

Citation

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.

Results Reference

derived

PubMed Identifier

32198149

Citation

Dercle L, Fronheiser M, Lu L, Du S, Hayes W, Leung DK, Roy A, Wilkerson J, Guo P, Fojo AT, Schwartz LH, Zhao B. Identification of Non-Small Cell Lung Cancer Sensitive to Systemic Cancer Therapies Using Radiomics. Clin Cancer Res. 2020 May 1;26(9):2151-2162. doi: 10.1158/1078-0432.CCR-19-2942. Epub 2020 Mar 20.

Results Reference

derived

PubMed Identifier

30215677

Citation

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.

Results Reference

derived

PubMed Identifier

29408986

Citation

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.

Results Reference

derived

PubMed Identifier

29023213

Citation

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.

Results Reference

derived

PubMed Identifier

26028407

Citation

Brahmer J, Reckamp KL, Baas P, Crino L, Eberhardt WE, Poddubskaya E, Antonia S, Pluzanski A, Vokes EE, Holgado E, Waterhouse D, Ready N, Gainor J, Aren Frontera O, Havel L, Steins M, Garassino MC, Aerts JG, Domine M, Paz-Ares L, Reck M, Baudelet C, Harbison CT, Lestini B, Spigel DR. Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Jul 9;373(2):123-35. doi: 10.1056/NEJMoa1504627. Epub 2015 May 31.

Results Reference

derived

Links:

URL

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Description

BMS Clinical Trial Information

URL

https://www.BMSStudyConnect.com

Description

BMS Clinical Trial Patient Recruiting

Learn more about this trial

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

Squamous Cell Non-small Cell Lung Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial