DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Squamous Cell Non-small Cell Lung Cancer

Intervention: Nivolumab (Biological); Docetaxel (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb


The purpose of the study is to compare the change in tumor size, and 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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Overall Survival (OS) of BMS-936558 (Nivolumab) versus Docetaxel in subjects with squamous cell NSCLC after failure of prior-platinum doublet-based chemotherapy

Secondary outcome:

ORR of BMS-936558 (Nivolumab) versus Docetaxel

PFS of BMS-936558 (Nivolumab) versus Docetaxel

Potential association between PD-L1 expression and efficacy measures (ORR, OS PFS) will be assessed

QoL measured by disease-related symptom improvement rate in BMS-936558 (Nivolumab) and Docetaxel groups


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


For more information regarding BMS clinical trial participation, please visit www. BMSStudyConnect. com 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

- An 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

Locations and Contacts

Local Institution, Buenos Aires C1280AEB, Argentina

Local Institution, Buenos Aires 1417, Argentina

Local Institution, Cordoba X5002AOQ, Argentina

Local Institution, Linz 4020, Austria

Local Institution, Salzburg 5020, Austria

Local Institution, Vienna 1130, Austria

Local Institution, Wels 4600, Austria

Local Institution, Antofagasta 240000, Chile

Local Institution, Santiago 7630370, Chile

Local Institution, Praha 8 180 81, Czech Republic

Local Institution, Avignon Cedes 9 84918, France

Local Institution, Caen 14000, France

Local Institution, Dijon 21000, France

Local Institution, La Roche Sur Yon Cedex 9 85925, France

Local Institution, Lyon Cedex 08 69373, France

Local Institution, Marseille Cedex 20 13915, France

Local Institution, Pierre Benite 69495, France

Local Institution, Rennes Cedex 9 35033, France

Local Institution, Strasbourg 67090, France

Local Institution, Toulouse 31300, France

Local Institution, Bad Berka 99437, Germany

Local Institution, Essen 45122, Germany

Local Institution, Gerlingen 70839, Germany

Local Institution, Grosshansdorf 22927, Germany

Local Institution, Heidelberg 69126, Germany

Local Institution, Koeln 51109, Germany

Local Institution, Budapest H-1121, Hungary

Local Institution, Bologna 40138, Italy

Local Institution, Meldola (fc) 47014, Italy

Local Institution, Milano 20133, Italy

Local Institution, Padova 35128, Italy

Local Institution, Perugia 06132, Italy

Local Institution, Ravenna 48100, Italy

Local Institution, Siena 53100, Italy

Local Institution, Amsterdam 1066 CX, Netherlands

Local Institution, Rotterdam 3015 CE, Netherlands

Local Institution, Arequipa 54, Peru

Local Institution, Lima 34, Peru

Local Institution, Lima L-27, Peru

Local Institution, Gdansk 80-952, Poland

Local Institution, Krakow 31-202, Poland

Local Institution, Olsztyn 10-513, Poland

Local Institution, Szczecin 70-891, Poland

Local Institution, Warszawa 02-781, Poland

Local Institution, Bucuresti 010976, Romania

Local Institution, Cluj-Napoca 400352, Romania

Local Institution, Constanta 900591, Romania

Local Institution, Craiova 200385, Romania

Local Institution, Iasi 700106, Romania

Local Institution, Timisoara 300167, Romania

Local Institution, Moscow 115 478, Russian Federation

Local Institution, St. Petersburg 198255, Russian Federation

Local Institution, Barakaldo 48903, Spain

Local Institution, Barcelona 08035, Spain

Local Institution, Madrid 28040, Spain

Local Institution, Madrid 28050, Spain

Local Institution, Sevilla 41013, Spain

Mayo Clinic Arizona, Scottsdale, Arizona 85259, United States

Local Institution, Capital Federal, Buenos Aires 1431, Argentina

Local Institution, Ciudad Autonoma De Buenos Aire, Buenos Aires CP1426ANZ, Argentina

City Of Hope National Medical Center, Duarte, California 91010, United States

Yale University, New Haven, Connecticut 06520, United States

Local Institution, Mexico, Distrito Federal 06735, Mexico

Local Institution, Tlalpan, Distrito Federal 14080, Mexico

Local Institution, Dublin 8, Dublin, Ireland

Local Institution, Dublin 9, Dublin, Ireland

Local Institution, Cottingham, East Yorkshire HU16 5JQ, United Kingdom

H. Lee Moffitt Cancer Center, Tampa, Florida 33612, United States

Northwest Georgia Oncology Center, P.C., Marietta, Georgia 30060, United States

Local Institution, Leon, Guanajato, Guanajuato 37000, Mexico

Local Institution, Southampton, Hampshire SO16 6YD, United Kingdom

University Of Chicago Medical Center, Chicago, Illinois 60637, United States

Local Institution, Withington, Manchester M20 4BX, United Kingdom

Cancercare Manitoba, Winnipeg, Manitoba R3E 0V9, Canada

The Johns Hopkins University, Baltimore, Maryland 21287, United States

Massachusetts General Hospital, Boston, Massachusetts 02114, United States

Local Institution, Santiago, Metropolitana 7600448, Chile

Local Institution, Wollongong, New South Wales 2500, Australia

Winthrop University Hospital, Mineola, New York 11501, United States

Columbia University Medical Center, New York, New York 10032, United States

Memorial Sloan Kettering Cancer Center, New York, New York 10065, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

Oncology Hematology Care, Cincinnati, Ohio 45242, United States

St Mary Medical Center, Langhorne, Pennsylvania 19047, United States

Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111, United States

Guthrie Clinic, Ltd, Sayre, Pennsylvania 18840, United States

Jewish General Hospital, Montreal, Quebec H3T 1E2, Canada

Centre De Sante Et De Services Sociaux Rimouski Neigette, Rimouski, Quebec G5L 5T1, Canada

Local Institution, Recoleta, Santiago de Chile, Chile

Local Institution, Hermosillo, Sonora 83280, Mexico

Local Institution, Adelaide, South Australia SA 5000, Australia

Local Institution, Elizabeth Vale, South Australia 5112, Australia

Local Institution, Kurralta Park, South Australia 5037, Australia

South Carolina Oncology Associates, Columbia, South Carolina 29210, United States

Chattanooga Oncology Hematology Associates, Chattanooga, Tennessee 37404, United States

Tennessee Oncology, Pllc, Nashville, Tennessee 37203, United States

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee 37232, United States

University Of Texas Southwestern Medical Center, Dallas, Texas 75390, United States

The University Of Texas Md Anderson Cancer Center, Houston, Texas 77030, United States

Local Institution, San Miguel De Tucuman, Tucuman CPT4000IAK, Argentina

Local Institution, Vi?a Del Mar, Valparaiso, Chile

Local Institution, East Bentleigh, Victoria 3165, Australia

Seattle Cancer Care Alliance, Seattle, Washington 98109, United States

Swedish Cancer Institute, Seattle, Washington 98104, United States

West Virginia University-Mbrcc, Morgantown, West Virginia 26506, United States

Local Institution, Sheffield, Yorkshire S10 2SJ, United Kingdom

Additional Information

BMS Clinical Trial Information

BMS clinical trial educational resource

Investigator Inquiry form

FDA Safety Alerts and Recalls

Starting date: September 2012
Last updated: August 19, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017