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

NCT01642004 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CA209-0172011-004792-36
• Study Type: interventional
• Target: 272
• Locations: 20 countries
• Sites: 123

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.

Conditions

Squamous Cell Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (9)

• Objective Response Rate (ORR) in All Randomized Participants

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

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

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

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

  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

• Progression Free Survival Rate (PFSR)

  From randomization to specified timepoints, up to 84 months

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

  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

Study Arms (2)

Arm A: Nivolumab

EXPERIMENTAL

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.

Biological: Nivolumab

Arm B: Docetaxel

EXPERIMENTAL

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.

Drug: Docetaxel

Interventions

Nivolumab BIOLOGICAL

Also known as: BMS-936558

Arm A: Nivolumab

Docetaxel DRUG

Also known as: Taxotere®

Arm B: Docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (127)

Mayo Clinic in Arizona - Scottsdale

Scottsdale, Arizona, 85259, United States

Location

City Of Hope

Duarte, California, 91010-3000, United States

Location

Local Institution - 0020

Duarte, California, 91010-3000, United States

Location

Local Institution - 0009

New Haven, Connecticut, 06520, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Local Institution - 0004

Tampa, Florida, 33612, United States

Location

Local Institution - 0153

Marietta, Georgia, 30060, United States

Location

Local Institution - 0100

Chicago, Illinois, 60637, United States

Location

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21287, United States

Location

Local Institution - 0003

Baltimore, Maryland, 21287, United States

Location

Local Institution - 0036

Boston, Massachusetts, 02114, United States

Location

Local Institution - 0084

Boston, Massachusetts, 02114, United States

Location

Local Institution - 0150

Boston, Massachusetts, 02114, United States

Location

Local Institution - 0016

Mineola, New York, 11501, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Local Institution - 0006

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau

New York, New York, 10065, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Local Institution - 0008

Durham, North Carolina, 27710, United States

Location

Oncology Hematology Care, Inc.

Cincinnati, Ohio, 45242, United States

Location

St Mary Medical Center

Langhorne, Pennsylvania, 19047, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Local Institution - 0011

Philadelphia, Pennsylvania, 19111, United States

Location

Guthrie Medical Group, Pc

Sayre, Pennsylvania, 18840, United States

Location

Local Institution - 0082

Columbia, South Carolina, 29210, United States

Location

Local Institution - 0087

Chattanooga, Tennessee, 37404, United States

Location

Local Institution - 0005

Nashville, Tennessee, 37203, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

Location

Local Institution - 0032

Nashville, Tennessee, 37232, United States

Location

Local Institution - 0012

Dallas, Texas, 75390, United States

Location

University Of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Local Institution - 0086

Houston, Texas, 77030, United States

Location

Local Institution - 0017

Seattle, Washington, 98104, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

Local Institution - 0001

Seattle, Washington, 98109, United States

Location

University of Washington - Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

Local Institution - 0033

Morgantown, West Virginia, 26506-9162, United States

Location

Local Institution - 0116

Capital Federal, Buenos Aires, 1431, Argentina

Location

Local Institution - 0072

Ciudad Autónoma de Buenos Aire, Buenos Aires, CP1426ANZ, Argentina

Location

Local Institution - 0164

San Miguel de Tucumán, Tucumán Province, CPT4000IAK, Argentina

Location

Local Institution - 0071

Buenos Aires, C1280AEB, Argentina

Location

Local Institution - 0141

Córdoba, X5002AOQ, Argentina

Location

Local Institution - 0073

Wollongong, New South Wales, 2500, Australia

Location

Local Institution - 0159

Adelaide, South Australia, 5000, Australia

Location

Local Institution - 0140

Elizabeth Vale, South Australia, 5112, Australia

Location

Local Institution - 0158

Kurralta Park, South Australia, 5037, Australia

Location

Local Institution - 0085

Clayton, Victoria, 3168, Australia

Location

Local Institution - 0102

Linz, 4020, Austria

Location

Local Institution - 0104

Salzburg, 5020, Austria

Location

Local Institution - 0049

Vienna, 1130, Austria

Location

Local Institution - 0103

Wels, 4600, Austria

Location

Local Institution - 0146

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Local Institution - 0147

Montreal, Quebec, H3T 1E2, Canada

Location

Local Institution - 0152

Rimouski, Quebec, G5L 5T1, Canada

Location

Local Institution - 0110

Viña del Mar, Región de Valparaíso, Chile

Location

Local Institution - 0117

Santiago, Santiago Metropolitan, 7600448, Chile

Location

Local Institution - 0131

Santiago, Santiago Metropolitan, 8420383, Chile

Location

Local Institution - 0161

Antofagasta, 240000, Chile

Location

Local Institution - 0154

Santiago, 7630370, Chile

Location

Local Institution - 0111

Prague, 180 81, Czechia

Location

Local Institution - 0053

Avignon Cedes 9, 84918, France

Location

Local Institution - 0156

Caen, 14000, France

Location

Local Institution - 0025

Dijon, 21000, France

Location

Local Institution

Dijon, 21000, France

Location

Local Institution - 0093

La Roche-sur-Yon, 85925, France

Location

Local Institution - 0022

Lyon, 69373, France

Location

Local Institution

Lyon, 69373, France

Location

Local Institution - 0023

Marseille, 13915, France

Location

Local Institution

Marseille, 13915, France

Location

Local Institution - 0160

Pierre-Bénite, 69495, France

Location

Local Institution - 0027

Rennes, 35033, France

Location

Local Institution

Rennes, 35033, France

Location

Local Institution - 0157

Strasbourg, 67090, France

Location

Local Institution - 0040

Toulouse, 31300, France

Location

Local Institution - 0064

Bad Berka, 99437, Germany

Location

Local Institution - 0063

Cologne, 51109, Germany

Location

Local Institution - 0105

Essen, 45122, Germany

Location

Local Institution - 0109

Gerlingen, 70839, Germany

Location

Local Institution - 0048

Großhansdorf, 22927, Germany

Location

Local Institution - 0065

Heidelberg, 69126, Germany

Location

Local Institution - 0162

Krefeld, 47805, Germany

Location

Local Institution - 0095

Budapest, H-1121, Hungary

Location

Local Institution - 0096

Budapest, H-1121, Hungary

Location

Local Institution - 0035

Dublin, Dublin, Ireland

Location

Local Institution - 0039

Dublin, Dublin, Ireland

Location

Local Institution - 0058

Bologna, 40138, Italy

Location

Local Institution - 0088

Meldola (fc), 47014, Italy

Location

Local Institution - 0057

Milan, 20133, Italy

Location

Local Institution - 0056

Padua, 35128, Italy

Location

Local Institution - 0055

Perugia, 06132, Italy

Location

Local Institution - 0089

Ravenna, 48121, Italy

Location

Local Institution - 0054

Siena, 53100, Italy

Location

Local Institution - 0106

Leon, Guanajato, Guanajuato, 37000, Mexico

Location

Local Institution - 0107

Mexico City, Mexico City, 06735, Mexico

Location

Local Institution - 0108

Mexico City, Mexico City, 14080, Mexico

Location

Local Institution - 0139

Hermosillo, Sonora, 83280, Mexico

Location

Local Institution - 0052

Amsterdam, 1066 CX, Netherlands

Location

Local Institution - 0051

Rotterdam, 3000 CA, Netherlands

Location

Local Institution - 0143

Oslo, 0310, Norway

Location

Local Institution - 0099

Arequipa, 54, Peru

Location

Local Institution - 0061

Lima, 34, Peru

Location

Local Institution - 0126

Gdansk, 80-952, Poland

Location

Local Institution - 0130

Krakow, 31-202, Poland

Location

Local Institution - 0129

Olsztyn, 10-513, Poland

Location

Local Institution - 0124

Szczecin, 70-891, Poland

Location

Local Institution - 0127

Warsaw, 02-781, Poland

Location

Local Institution - 0136

Bucharest, 010976, Romania

Location

Local Institution - 0145

Cluj-Napoca, 400352, Romania

Location

Local Institution - 0138

Constanța, 900591, Romania

Location

Local Institution - 0121

Craiova, 200385, Romania

Location

Local Institution - 0119

Iași, 700106, Romania

Location

Local Institution - 0120

Timișoara, 300167, Romania

Location

Local Institution - 0132

Moscow, 115 478, Russia

Location

Local Institution - 0133

Moscow, 115 478, Russia

Location

Local Institution - 0144

Moscow, 115 478, Russia

Location

Local Institution - 0135

Saint Petersburg, 198255, Russia

Location

Local Institution - 0044

Barakaldo, Vizcaya, 48903, Spain

Location

Local Institution - 0042

Barcelona, 08035, Spain

Location

Local Institution - 0046

Madrid, 28040, Spain

Location

Local Institution - 0045

Madrid, 28050, Spain

Location

Local Institution - 0041

Seville, 41013, Spain

Location

Local Institution - 0047

Cottingham, East Yorkshire, HU16 5JQ, United Kingdom

Location

Local Institution - 0034

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Local Institution - 0163

Withington, Manchester, M20 4BX, United Kingdom

Location

Local Institution - 0037

Sheffield, Yorkshire, S10 2SJ, United Kingdom

Location

Related Publications (7)

• Hu S, Tang Z, Harrison JP, Hertel N, Penrod JR, May JR, Juarez-Garcia A, Holdgate O. Economic Evaluation of Nivolumab Versus Docetaxel for the Treatment of Advanced Squamous and Non-squamous Non-small Cell Lung Cancer After Prior Chemotherapy in China. Pharmacoecon Open. 2023 Mar;7(2):273-284. doi: 10.1007/s41669-022-00383-x. Epub 2023 Mar 10.

  PMID: 36897427 DERIVED

• 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.

  PMID: 33449799 DERIVED

• 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.

  PMID: 32198149 DERIVED

• 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.

  PMID: 30215677 DERIVED

• 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.

  PMID: 29408986 DERIVED

• 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.

  PMID: 29023213 DERIVED

• 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.

  PMID: 26028407 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

Nivolumab; Docetaxel

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2012
• First Posted: July 17, 2012
• Study Start: October 16, 2012
• Primary Completion: November 17, 2014
• Study Completion: August 16, 2021
• Last Updated: December 28, 2022
• Results First Posted: March 17, 2016

Record last verified: 2022-11

Locations

CA (3); ME (4); PE (2); NL (2); IT (7); NO (1); CZ (1); CL (5); RU (4); ES (5); DE (7); AU (5); FR (14); PL (5); RO (6); US (39); GB (4); IE (2); AR (5); HU (2)