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

NCT ID: NCT01642004

Last Updated: 2022-12-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 272 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-16
• Study Completion Date: 2021-08-16

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A: Nivolumab

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.

Group Type: EXPERIMENTAL

Nivolumab

Intervention Type: BIOLOGICAL

Arm B: Docetaxel

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.

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

Interventions

Nivolumab

Intervention Type: BIOLOGICAL

Docetaxel

Intervention Type: DRUG

Other Intervention Names

BMS-936558; Taxotere®

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Mayo Clinic in Arizona - Scottsdale

Scottsdale, Arizona, United States

City Of Hope

Duarte, California, United States

Local Institution - 0020

Duarte, California, United States

Local Institution - 0009

New Haven, Connecticut, United States

Yale University

New Haven, Connecticut, United States

H. Lee Moffitt Cancer Center

Tampa, Florida, United States

Local Institution - 0004

Tampa, Florida, United States

Local Institution - 0153

Marietta, Georgia, United States

Local Institution - 0100

Chicago, Illinois, United States

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Local Institution - 0003

Baltimore, Maryland, United States

Local Institution - 0036

Boston, Massachusetts, United States

Local Institution - 0084

Boston, Massachusetts, United States

Local Institution - 0150

Boston, Massachusetts, United States

Local Institution - 0016

Mineola, New York, United States

Winthrop University Hospital

Mineola, New York, United States

Columbia University Medical Center

New York, New York, United States

Local Institution - 0006

New York, New York, United States

Memorial Sloan Kettering Nassau

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Local Institution - 0008

Durham, North Carolina, United States

Oncology Hematology Care, Inc.

Cincinnati, Ohio, United States

St Mary Medical Center

Langhorne, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Local Institution - 0011

Philadelphia, Pennsylvania, United States

Guthrie Medical Group, Pc

Sayre, Pennsylvania, United States

Local Institution - 0082

Columbia, South Carolina, United States

Local Institution - 0087

Chattanooga, Tennessee, United States

Local Institution - 0005

Nashville, Tennessee, United States

Tennessee Oncology, PLLC

Nashville, Tennessee, United States

Local Institution - 0032

Nashville, Tennessee, United States

Local Institution - 0012

Dallas, Texas, United States

University Of Texas Southwestern Medical Center

Dallas, Texas, United States

Local Institution - 0086

Houston, Texas, United States

Local Institution - 0017

Seattle, Washington, United States

Swedish Cancer Institute

Seattle, Washington, United States

Local Institution - 0001

Seattle, Washington, United States

University of Washington - Seattle Cancer Care Alliance

Seattle, Washington, United States

Local Institution - 0033

Morgantown, West Virginia, United States

Local Institution - 0116

Capital Federal, Buenos Aires, Argentina

Local Institution - 0072

Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina

Local Institution - 0164

San Miguel de Tucumán, Tucumán Province, Argentina

Local Institution - 0071

Buenos Aires, , Argentina

Local Institution - 0141

Córdoba, , Argentina

Local Institution - 0073

Wollongong, New South Wales, Australia

Local Institution - 0159

Adelaide, South Australia, Australia

Local Institution - 0140

Elizabeth Vale, South Australia, Australia

Local Institution - 0158

Kurralta Park, South Australia, Australia

Local Institution - 0085

Clayton, Victoria, Australia

Local Institution - 0102

Linz, , Austria

Local Institution - 0104

Salzburg, , Austria

Local Institution - 0049

Vienna, , Austria

Local Institution - 0103

Wels, , Austria

Local Institution - 0146

Winnipeg, Manitoba, Canada

Local Institution - 0147

Montreal, Quebec, Canada

Local Institution - 0152

Rimouski, Quebec, Canada

Local Institution - 0110

Viña del Mar, Región de Valparaíso, Chile

Local Institution - 0117

Santiago, Santiago Metropolitan, Chile

Local Institution - 0131

Santiago, Santiago Metropolitan, Chile

Local Institution - 0161

Antofagasta, , Chile

Local Institution - 0154

Santiago, , Chile

Local Institution - 0111

Prague, , Czechia

Local Institution - 0053

Avignon Cedes 9, , France

Local Institution - 0156

Caen, , France

Local Institution - 0025

Dijon, , France

Local Institution

Dijon, , France

Local Institution - 0093

La Roche-sur-Yon, , France

Local Institution - 0022

Lyon, , France

Local Institution

Lyon, , France

Local Institution - 0023

Marseille, , France

Local Institution

Marseille, , France

Local Institution - 0160

Pierre-Bénite, , France

Local Institution - 0027

Rennes, , France

Local Institution

Rennes, , France

Local Institution - 0157

Strasbourg, , France

Local Institution - 0040

Toulouse, , France

Local Institution - 0064

Bad Berka, , Germany

Local Institution - 0063

Cologne, , Germany

Local Institution - 0105

Essen, , Germany

Local Institution - 0109

Gerlingen, , Germany

Local Institution - 0048

Großhansdorf, , Germany

Local Institution - 0065

Heidelberg, , Germany

Local Institution - 0162

Krefeld, , Germany

Local Institution - 0095

Budapest, , Hungary

Local Institution - 0096

Budapest, , Hungary

Local Institution - 0035

Dublin, Dublin, Ireland

Local Institution - 0039

Dublin, Dublin, Ireland

Local Institution - 0058

Bologna, , Italy

Local Institution - 0088

Meldola (fc), , Italy

Local Institution - 0057

Milan, , Italy

Local Institution - 0056

Padua, , Italy

Local Institution - 0055

Perugia, , Italy

Local Institution - 0089

Ravenna, , Italy

Local Institution - 0054

Siena, , Italy

Local Institution - 0106

Leon, Guanajato, Guanajuato, Mexico

Local Institution - 0107

Mexico City, Mexico City, Mexico

Local Institution - 0108

Mexico City, Mexico City, Mexico

Local Institution - 0139

Hermosillo, Sonora, Mexico

Local Institution - 0052

Amsterdam, , Netherlands

Local Institution - 0051

Rotterdam, , Netherlands

Local Institution - 0143

Oslo, , Norway

Local Institution - 0099

Arequipa, , Peru

Local Institution - 0061

Lima, , Peru

Local Institution - 0126

Gdansk, , Poland

Local Institution - 0130

Krakow, , Poland

Local Institution - 0129

Olsztyn, , Poland

Local Institution - 0124

Szczecin, , Poland

Local Institution - 0127

Warsaw, , Poland

Local Institution - 0136

Bucharest, , Romania

Local Institution - 0145

Cluj-Napoca, , Romania

Local Institution - 0138

Constanța, , Romania

Local Institution - 0121

Craiova, , Romania

Local Institution - 0119

Iași, , Romania

Local Institution - 0120

Timișoara, , Romania

Local Institution - 0132

Moscow, , Russia

Local Institution - 0133

Moscow, , Russia

Local Institution - 0144

Moscow, , Russia

Local Institution - 0135

Saint Petersburg, , Russia

Local Institution - 0044

Barakaldo, Vizcaya, Spain

Local Institution - 0042

Barcelona, , Spain

Local Institution - 0046

Madrid, , Spain

Local Institution - 0045

Madrid, , Spain

Local Institution - 0041

Seville, , Spain

Local Institution - 0047

Cottingham, East Yorkshire, United Kingdom

Local Institution - 0034

Southampton, Hampshire, United Kingdom

Local Institution - 0163

Withington, Manchester, United Kingdom

Local Institution - 0037

Sheffield, Yorkshire, United Kingdom

Countries

Brazil; Greece; South Africa; Turkey (Türkiye); United States; Argentina; Australia; Austria; Canada; Chile; Czechia; France; Germany; Hungary; Ireland; Italy; Mexico; Netherlands; Norway; Peru; Poland; Romania; Russia; Spain; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 36897427 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33449799 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32198149 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30215677 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29408986 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29023213 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26028407 (View on PubMed)

Related Links

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

BMS Clinical Trial Information

https://www.BMSStudyConnect.com

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Other Identifiers

2011-004792-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA209-017

Identifier Type: -

Identifier Source: org_study_id