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

NCT ID: NCT01673867

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 582 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-02
• Study Completion Date: 2021-12-17

Brief Summary

The purpose of the study is to compare the overall survival of BMS-936558 (Nivolumab) as compared with Docetaxel in subjects with non-squamous cell non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy

Detailed Description

CheckMate 057: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 057

Conditions

Non-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: ACTIVE_COMPARATOR

Docetaxel

Intervention Type: DRUG

Interventions

Nivolumab

Intervention Type: BIOLOGICAL

Docetaxel

Intervention Type: DRUG

Other Intervention Names

BMS-936558 (Anti-PD1); Taxotere®

Eligibility Criteria

Inclusion Criteria

• Men & women ≥18 years of age
• Subjects with histologically or cytologically-documented non-squamous cell NSCLC who present with Stage IIIB/IV disease or recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection, or definitive chemoradiation therapy for locally advanced disease) and who will receive study therapy as second or third line of treatment for 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 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 asymptomatic or 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 ≤10mg daily prednisone (or equivalent)
• Subjects with carcinomatous meningitis
• Subjects with active or recent history of known or suspected autoimmune disease. Subjects with Type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, or skin disorders (vitiligo, psoriasis, or alopecia) not requiring systemic treatment 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 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), anti-programmed cell death ligand 2 (anti-PD-L2), anti-cluster of differentiation 137 (anti-CD137), or anti-Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibody (including Ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
• Prior treatment with Docetaxel
• 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 Arizona

Scottsdale, Arizona, United States

Local Institution - 0009

Duarte, California, United States

Local Institution - 0042

San Diego, California, United States

San Francisco Oncology Associates

San Francisco, California, United States

Yale University

New Haven, Connecticut, United States

Local Institution - 0034

Tampa, Florida, United States

Northwest Georgia Oncology Center, P.C.

Marietta, Georgia, United States

Local Institution - 0030

Chicago, Illinois, United States

The Johns Hopkins University

Baltimore, Maryland, United States

Local Institution - 0031

Boston, Massachusetts, United States

Local Institution - 0040

Boston, Massachusetts, United States

Local Institution - 0138

Boston, Massachusetts, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Local Institution - 0008

Mineola, New York, United States

Local Institution - 0020

New York, New York, United States

Local Institution - 0027

Durham, North Carolina, United States

Local Institution - 0026

Cincinnati, Ohio, United States

St. Mary Medical Center

Langhorne, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Local Institution - 0035

Sayre, Pennsylvania, United States

Local Institution - 0025

Columbia, South Carolina, United States

Local Institution - 0024

Chattanooga, Tennessee, United States

Local Institution - 0028

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Local Institution - 0033

Dallas, Texas, United States

Local Institution - 0032

Houston, Texas, United States

Local Institution - 0041

Kennewick, Washington, United States

Swedish Cancer Institute

Seattle, Washington, United States

Local Institution - 0007

Seattle, Washington, United States

Local Institution - 0019

Morgantown, West Virginia, United States

Local Institution - 0010

Capital Federal, Buenos Aires, Argentina

Local Institution - 0057

Capital Federal, Buenos Aires, Argentina

Local Institution - 0124

Ciudad de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0011

Buenos Aires, , Argentina

Local Institution - 0125

La Rioja, , Argentina

Local Institution

Tweed Heads, New South Wales, Australia

Local Institution

Woolloongabba, Queensland, Australia

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Adelaide, South Australia, Australia

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Kurralta Park, South Australia, Australia

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Frankston, Victoria, Australia

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Melbourne, Victoria, Australia

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Linz, , Austria

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Salzburg, , Austria

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Vienna, , Austria

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Wels, , Austria

Local Institution - 0056

Fortaleza, Ceará, Brazil

Local Institution - 0054

Salvador, Estado de Bahia, Brazil

Local Institution - 0053

Porto Alegre, Rio Grande do Sul, Brazil

Local Institution - 0055

Porto Alegre, Rio Grande do Sul, Brazil

Local Institution - 0052

Barretos, São Paulo, Brazil

Local Institution - 0051

Rio de Janeiro, , Brazil

Local Institution - 0133

Edmonton, Alberta, Canada

Local Institution

London, Ontario, Canada

Local Institution - 0110

Rimouski, Quebec, Canada

Local Institution - 0012

Viña del Mar, Región de Valparaíso, Chile

Local Institution - 0058

Santiago, Santiago Metropolitan, Chile

Local Institution - 0077

Santiago, Santiago Metropolitan, Chile

Local Institution - 0134

Santiago, Santiago Metropolitan, Chile

Local Institution - 0018

Prague, , Czechia

Local Institution

Créteil, , France

Local Institution

Dijon, , France

Local Institution - 0119

La Roche-sur-Yon, , France

Local Institution - 0113

Lyon, , France

Local Institution - 0112

Marseille, , France

Local Institution

Poitiers, , France

Local Institution - 0114

Rennes, , France

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Toulouse, , France

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Bad Berka, , Germany

Local Institution - 0090

Cologne, , Germany

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Großhansdorf, , Germany

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Heidelberg, , Germany

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Mainz, , Germany

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Recklinghausen, , Germany

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Stuttgart, , Germany

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Ulm, , Germany

Local Institution - 0043

Hong Kong, , Hong Kong

Local Institution

Hong Kong, , Hong Kong

Local Institution - 0074

Budapest, , Hungary

Local Institution - 0122

Bergamo, , Italy

Local Institution - 0086

Bologna, , Italy

Local Institution - 0087

Meldola (fc), , Italy

Local Institution - 0085

Milan, , Italy

Local Institution - 0084

Padua, , Italy

Local Institution - 0121

Parma, , Italy

Local Institution - 0083

Perugia, , Italy

Local Institution - 0088

Ravenna, , Italy

Local Institution - 0082

Siena, , Italy

Local Institution - 0107

Mexico City, Mexico City, Mexico

Local Institution - 0108

Mexico City, Mexico City, Mexico

Local Institution

Monterrey, Nuevo León, Mexico

Local Institution

Hermosillo, Sonora, Mexico

Local Institution - 0141

Oslo, , Norway

Local Institution - 0131

Miraflores, Lima region, Peru

Local Institution - 0050

Arequipa, , Peru

Local Institution - 0048

Lima, , Peru

Local Institution - 0049

Lima, , Peru

Local Institution - 0073

Krakow, Lesser Poland Voivodeship, Poland

Local Institution - 0068

Gdansk, , Poland

Local Institution - 0072

Olsztyn, , Poland

Local Institution - 0067

Szczecin, , Poland

Local Institution - 0070

Warsaw, , Poland

Local Institution - 0099

Bucharest, , Romania

Local Institution - 0123

Cluj-Napoca, , Romania

Local Institution - 0063

Craiova, , Romania

Local Institution - 0061

Iași, , Romania

Local Institution - 0062

Timișoara, , Romania

Local Institution - 0078

Moscow, , Russia

Local Institution - 0079

Moscow, , Russia

Local Institution - 0120

Moscow, , Russia

Local Institution - 0080

Saint Petersburg, , Russia

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Singapore, , Singapore

Local Institution

Singapore, , Singapore

Local Institution

Barcelona, , Spain

Local Institution

Madrid, , Spain

Local Institution

Madrid, , Spain

Local Institution - 0001

Seville, , Spain

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Vizcaya, , Spain

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Basel, , Switzerland

Local Institution

Chur, , Switzerland

Countries

United States; Argentina; Australia; Austria; Brazil; Canada; Chile; Czechia; France; Germany; Hong Kong; Hungary; Italy; Mexico; Norway; Peru; Poland; Romania; Russia; Singapore; Spain; Switzerland

References

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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.

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Other Identifiers

2012-002472-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA209-057

Identifier Type: -

Identifier Source: org_study_id