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

NCT01673867 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: CA209-0572012-002472-14
• Study Type: interventional
• Target: 582
• Locations: 21 countries
• Sites: 115

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

Conditions

Non-Squamous Cell Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

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

  Overall survival was defined as the time from randomization to the date of death. A participant who has not died will be censored at last known date alive. OS will be followed continuously while participants are on the study drug and every 3 months via in-person or phone contact after participants discontinue the study drug. Median and hazard ratio computed using Kaplan-Meier method.

  Randomization until 413 deaths, up to March 2015 (approximately 29 months)

Secondary Outcomes (7)

• Objective Response Rate (ORR)

  From randomization to date of objectively documented progression (up to approximately 110 months)

• Time To Objective Response (TTOR)

  From randomization to the date of first confirmed response (up to approximately 110 months)

• Duration of Objective Response (DOOR)

  From randomization to date of first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 110 months)

• Progression-Free Survival (PFS)

  From randomization to first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 110 months)

• Percentage of Participants Experiencing Disease-Related Symptom Improvement by Week 12

  Randomization to Week 12

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

ACTIVE COMPARATOR

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 (Anti-PD1)

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 \& 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (119)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

Local Institution - 0009

Duarte, California, 91010, United States

Location

Local Institution - 0042

San Diego, California, 92123, United States

Location

San Francisco Oncology Associates

San Francisco, California, 94115, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Local Institution - 0034

Tampa, Florida, 33612, United States

Location

Northwest Georgia Oncology Center, P.C.

Marietta, Georgia, 30060, United States

Location

Local Institution - 0030

Chicago, Illinois, 60637, United States

Location

The Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Local Institution - 0031

Boston, Massachusetts, 02215, United States

Location

Local Institution - 0040

Boston, Massachusetts, 02215, United States

Location

Local Institution - 0138

Boston, Massachusetts, 02215, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Local Institution - 0008

Mineola, New York, 11501, United States

Location

Local Institution - 0020

New York, New York, 10065, United States

Location

Local Institution - 0027

Durham, North Carolina, 27710, United States

Location

Local Institution - 0026

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 - 0035

Sayre, Pennsylvania, 18840, United States

Location

Local Institution - 0025

Columbia, South Carolina, 29210, United States

Location

Local Institution - 0024

Chattanooga, Tennessee, 37404, United States

Location

Local Institution - 0028

Nashville, Tennessee, 37203, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Local Institution - 0033

Dallas, Texas, 75390, United States

Location

Local Institution - 0032

Houston, Texas, 77030, United States

Location

Local Institution - 0041

Kennewick, Washington, 99336, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

Local Institution - 0007

Seattle, Washington, 98109, United States

Location

Local Institution - 0019

Morgantown, West Virginia, 26506-9162, United States

Location

Local Institution - 0010

Capital Federal, Buenos Aires, 1426, Argentina

Location

Local Institution - 0057

Capital Federal, Buenos Aires, 1431, Argentina

Location

Local Institution - 0124

Ciudad de Buenos Aires, Buenos Aires, C1181ACH, Argentina

Location

Local Institution - 0011

Buenos Aires, C1280AEB, Argentina

Location

Local Institution - 0125

La Rioja, 5300, Argentina

Location

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Tweed Heads, New South Wales, 2485, Australia

Location

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Woolloongabba, Queensland, 4102, Australia

Location

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Adelaide, South Australia, 5000, Australia

Location

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Kurralta Park, South Australia, 5037, Australia

Location

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Frankston, Victoria, 3199, Australia

Location

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Melbourne, Victoria, 3065, Australia

Location

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Linz, 4020, Austria

Location

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Salzburg, 5020, Austria

Location

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Vienna, 1130, Austria

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Wels, 4600, Austria

Location

Local Institution - 0056

Fortaleza, Ceará, 60336550, Brazil

Location

Local Institution - 0054

Salvador, Estado de Bahia, 40170-110, Brazil

Location

Local Institution - 0053

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Local Institution - 0055

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Local Institution - 0052

Barretos, São Paulo, 14784-400, Brazil

Location

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Rio de Janeiro, 20231-050, Brazil

Location

Local Institution - 0133

Edmonton, Alberta, T6G 1Z2, Canada

Location

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London, Ontario, N6A 4L6, Canada

Location

Local Institution - 0110

Rimouski, Quebec, G5L 5T1, Canada

Location

Local Institution - 0012

Viña del Mar, Región de Valparaíso, Chile

Location

Local Institution - 0058

Santiago, Santiago Metropolitan, 7600448, Chile

Location

Local Institution - 0077

Santiago, Santiago Metropolitan, 8420383, Chile

Location

Local Institution - 0134

Santiago, Santiago Metropolitan, Chile

Location

Local Institution - 0018

Prague, 180 81, Czechia

Location

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Créteil, 94010, France

Location

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Dijon, 21079, France

Location

Local Institution - 0119

La Roche-sur-Yon, 85925, France

Location

Local Institution - 0113

Lyon, 69373, France

Location

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Marseille, 13915, France

Location

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Poitiers, 86000, France

Location

Local Institution - 0114

Rennes, 35033, France

Location

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Toulouse, 31300, France

Location

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Bad Berka, 99437, Germany

Location

Local Institution - 0090

Cologne, 51109, Germany

Location

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Großhansdorf, 22927, Germany

Location

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Heidelberg, 69126, Germany

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Mainz, 55131, Germany

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Recklinghausen, 45657, Germany

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Stuttgart, 70376, Germany

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Ulm, 89081, Germany

Location

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Hong Kong, 0, Hong Kong

Location

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Hong Kong, Hong Kong

Location

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Budapest, H-1121, Hungary

Location

Local Institution - 0122

Bergamo, 24127, Italy

Location

Local Institution - 0086

Bologna, 40138, Italy

Location

Local Institution - 0087

Meldola (fc), 47014, Italy

Location

Local Institution - 0085

Milan, 20133, Italy

Location

Local Institution - 0084

Padua, 35128, Italy

Location

Local Institution - 0121

Parma, 43100, Italy

Location

Local Institution - 0083

Perugia, 06132, Italy

Location

Local Institution - 0088

Ravenna, 48121, Italy

Location

Local Institution - 0082

Siena, 53100, Italy

Location

Local Institution - 0107

Mexico City, Mexico City, 06735, Mexico

Location

Local Institution - 0108

Mexico City, Mexico City, 14080, Mexico

Location

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Monterrey, Nuevo León, 64060, Mexico

Location

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Hermosillo, Sonora, 83280, Mexico

Location

Local Institution - 0141

Oslo, 0424, Norway

Location

Local Institution - 0131

Miraflores, Lima region, 18, Peru

Location

Local Institution - 0050

Arequipa, 54, Peru

Location

Local Institution - 0048

Lima, 34, Peru

Location

Local Institution - 0049

Lima, L-27, Peru

Location

Local Institution - 0073

Krakow, Lesser Poland Voivodeship, 30-002, Poland

Location

Local Institution - 0068

Gdansk, 80-19, Poland

Location

Local Institution - 0072

Olsztyn, 10-513, Poland

Location

Local Institution - 0067

Szczecin, 70891, Poland

Location

Local Institution - 0070

Warsaw, 02-781, Poland

Location

Local Institution - 0099

Bucharest, 010976, Romania

Location

Local Institution - 0123

Cluj-Napoca, 400352, Romania

Location

Local Institution - 0063

Craiova, 200385, Romania

Location

Local Institution - 0061

Iași, 700106, Romania

Location

Local Institution - 0062

Timișoara, 300167, Romania

Location

Local Institution - 0078

Moscow, 115 478, Russia

Location

Local Institution - 0079

Moscow, 115 478, Russia

Location

Local Institution - 0120

Moscow, 115 478, Russia

Location

Local Institution - 0080

Saint Petersburg, 197022, Russia

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Singapore, 169610, Singapore

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Singapore, 308433, Singapore

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Barcelona, 08035, Spain

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Madrid, 28040, Spain

Location

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Madrid, 28050, Spain

Location

Local Institution - 0001

Seville, 41013, Spain

Location

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Vizcaya, 48903, Spain

Location

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Basel, 4031, Switzerland

Location

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Chur, 7000, Switzerland

Location

Related Publications (8)

• Barrera C, Corredor G, Viswanathan VS, Ding R, Toro P, Fu P, Buzzy C, Lu C, Velu P, Zens P, Berezowska S, Belete M, Balli D, Chang H, Baxi V, Syrigos K, Rimm DL, Velcheti V, Schalper K, Romero E, Madabhushi A. Deep computational image analysis of immune cell niches reveals treatment-specific outcome associations in lung cancer. NPJ Precis Oncol. 2023 Jun 1;7(1):52. doi: 10.1038/s41698-023-00403-x.

  PMID: 37264091 DERIVED

• 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

• 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

• Reck M, Brahmer J, Bennett B, Taylor F, Penrod JR, DeRosa M, Dastani H, Spigel DR, Gralla RJ. Evaluation of health-related quality of life and symptoms in patients with advanced non-squamous non-small cell lung cancer treated with nivolumab or docetaxel in CheckMate 057. Eur J Cancer. 2018 Oct;102:23-30. doi: 10.1016/j.ejca.2018.05.005. Epub 2018 Aug 10.

  PMID: 30103096 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

• Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, Chow LQ, Vokes EE, Felip E, Holgado E, Barlesi F, Kohlhaufl M, Arrieta O, Burgio MA, Fayette J, Lena H, Poddubskaya E, Gerber DE, Gettinger SN, Rudin CM, Rizvi N, Crino L, Blumenschein GR Jr, Antonia SJ, Dorange C, Harbison CT, Graf Finckenstein F, Brahmer JR. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Oct 22;373(17):1627-39. doi: 10.1056/NEJMoa1507643. Epub 2015 Sep 27.

  PMID: 26412456 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls
• Investigator Inquiry Form

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
• Expanded Access: Yes

Study Record Dates

• First Submitted: August 24, 2012
• First Posted: August 28, 2012
• Study Start: November 2, 2012
• Primary Completion: February 5, 2015
• Study Completion: December 17, 2021
• Last Updated: February 8, 2023
• Results First Posted: February 26, 2016

Record last verified: 2023-01

Locations

SG (2); ES (5); HU (1); RO (5); CL (4); AU (6); HK (2); IT (9); PL (5); DE (8); FR (8); US (30); CZ (1); CA (3); CH (2); PE (4); NO (1); BR (6); RU (4); ME (4); AR (5)