Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of Two Doses of MK-3475 (Pembrolizumab) Versus Docetaxel in Previously-Treated Participants With Non-Small Cell Lung Cancer (MK-3475-010/KEYNOTE-010)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: July 18, 2013
Last updated: February 25, 2015
Last verified: February 2015

This study will compare two doses of pembrolizumab versus docetaxel in participants with non-small cell lung cancer (NSCLC) who have experienced disease progression after platinum-containing systemic therapy. Participants will be assigned randomly to receive either Low Dose or High Dose pembrolizumab every three weeks (Q3W), or docetaxel at 75 mg/m^2 Q3W. This study will use an adaptive trial design so that the total number of participants randomized will depend upon demonstration of sufficient objective responses at interim analysis. If the pembrolizumab Low Dose arm is closed, participants may receive pembrolizumab High Dose therapy.

Condition Intervention Phase
Non Small Cell Lung Cancer (NSCLC)
Biological: pembrolizumab
Drug: Docetaxel
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II/III Randomized Trial of Two Doses of MK-3475 (SCH900475) Versus Docetaxel in Previously Treated Subjects With Non-Small Cell Lung Cancer

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Progression free survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Number of participants experiencing adverse events [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
  • Number of participants discontinuing study drug due to adverse events [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall response rate (ORR) by RECIST 1.1 [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Response duration by RECIST 1.1 [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 920
Study Start Date: August 2013
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pembrolizumab Low Dose
Participants receive pembrolizumab, intravenously (IV) over 30 minutes Q3W
Biological: pembrolizumab
Experimental: Pembrolizumab High Dose
Participants receive pembrolizumab, IV over 30 minutes Q3W
Biological: pembrolizumab
Active Comparator: Docetaxel 75 mg/m^2
Participants receive 75 mg/m^2 docetaxel, IV over 1 hour Q3W
Drug: Docetaxel


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Life expectancy of at least 3 months
  • Histologically- or cytologically-confirmed diagnosis of non-small cell lung cancer (NSCLC) that is PD-L1 positive per central laboratory review
  • At least one bi-dimensional measurable lesion
  • Radiographic progression after treatment with at least 2 cycles of a platinum-containing doublet
  • Currently participating or has participated in a study using an investigational antineoplastic agent or device within 30 days of first dose
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria:

  • Prior therapy with docetaxel for NSCLC
  • Receiving systemic steroid therapy within three days prior to the first dose of study treatment or receiving any other form of immunosuppressive medication
  • Expected to require any other form of systemic or localized antineoplastic therapy while on trial
  • History of allogeneic tissue/solid organ transplant
  • Prior systemic cytotoxic chemotherapy, antineoplastic biological therapy (e.g., cetuximab), major surgery within 3 weeks of the first dose of study drug; received thoracic radiation therapy of >30 Gray within 6 months of the first dose of study drug; received prior tyrosine kinase inhibitor therapy or completed palliative radiotherapy within 7 days of the first dose of study drug
  • Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-tumor necrosis factor 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), or took part in another pembrolizumab trial
  • Known history of prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cervical cancer, and has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Active autoimmune disease, or a documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
  • Interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment
  • Known history or active human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
  • Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial through 120 days after last dose of pembrolizumab or 180 days after last dose of docetaxel
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01905657

Contact: Toll Free Number 1-888-577-8839

  Hide Study Locations
United States, Alabama
Call for Information (Investigational Site 0053) Recruiting
Birmingham, Alabama, United States, 35294-3300
United States, Arkansas
Call for Information (Investigational Site 0045) Recruiting
Jonesboro, Arkansas, United States, 72401
United States, California
Call for Information (Investigational Site 0017) Recruiting
Beverly Hills, California, United States, 90211
Call for Information (Investigational Site 0055) Recruiting
La Jolla, California, United States, 92093
Call for Information (Investigational Site 0058) Recruiting
Los Angeles, California, United States, 90095
Call for Information (Investigational Site 0060) Recruiting
Los Angeles, California, United States, 90025
Call for Information (Investigational Site 0054) Recruiting
Palo Alto, California, United States, 94085
Call for Information (Investigational Site 0014) Recruiting
Sacramento, California, United States, 95817
Call for Information (Investigational Site 0015) Recruiting
San Francisco, California, United States, 94115
United States, Connecticut
Call for Information (Investigational Site 0051) Recruiting
New Haven, Connecticut, United States, 06520
United States, Georgia
Call for Information (Investigational Site 0048) Recruiting
Atlanta, Georgia, United States, 30322
United States, Illinois
Call for Information (Investigational Site 0003) Recruiting
Chicago, Illinois, United States, 60612
Call for Information (Investigational Site 0047) Recruiting
Chicago, Illinois, United States, 60637
Call for Information (Investigational Site 0063) Recruiting
Chicago, Illinois, United States, 60611
United States, Iowa
Call for Information (Investigational Site 0002) Recruiting
Iowa City, Iowa, United States, 52242
United States, Maryland
Call for Information (Investigational Site 0037) Recruiting
Baltimore, Maryland, United States, 21201
Call for Information (Investigational Site 0044) Recruiting
Baltimore, Maryland, United States, 21237
Call for Information (Investigational Site 0033) Recruiting
Rockville, Maryland, United States, 20850
United States, Massachusetts
Call for Information (Investigational Site 0024) Recruiting
Boston, Massachusetts, United States, 02215
Call for Information (Investigational Site 0056) Recruiting
Boston, Massachusetts, United States, 02115
Call for Information (Investigational Site 0059) Recruiting
Worchester, Massachusetts, United States, 01655
United States, Michigan
Call for Information (Investigational Site 0005) Recruiting
Ann Arbor, Michigan, United States, 48109-5848
Call for Information (Investigational Site 0040) Recruiting
Detroit, Michigan, United States, 48202
Call for Information (Investigational Site 0004) Recruiting
Detroit, Michigan, United States, 48201
United States, Minnesota
Call for Information (Investigational Site 0006) Recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
Call for Information (Investigational Site 0046) Recruiting
St. Louis, Missouri, United States, 63110
United States, New York
Call for Information (Investigational Site 0061) Recruiting
New York, New York, United States, 10032
Call for Information (Investigational Site 0026) Recruiting
Rochester, New York, United States, 14642
United States, North Carolina
Call for Information (Investigational Site 0028) Recruiting
Charlotte, North Carolina, United States, 28203
United States, Ohio
Call for Information (Investigational Site 0007) Recruiting
Akron, Ohio, United States, 44304
United States, Oregon
Call for Information (Investigational Site 0049) Recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Call for Information (Investigational Site 0062) Recruiting
Hershey, Pennsylvania, United States, 17033
Call for Information (Investigational Site 0019) Recruiting
Philadelphia, Pennsylvania, United States, 19111
Call for Information (Investigational Site 0027) Recruiting
Philadelphia, Pennsylvania, United States, 19104
Call for Information (Investigational Site 0057) Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Call for Information (Investigational Site 0050) Recruiting
Houston, Texas, United States, 77030
Call for Information (Investigational Site 0011) Recruiting
San Antonio, Texas, United States, 78229
United States, Wisconsin
Call for Information (Investigational Site 0052) Recruiting
Madison, Wisconsin, United States, 53792-0001
Merck Sharp & Dohme (Argentina) Inc. Recruiting
Buenos Aires, Argentina
Contact: Alfredo Wilkinson    54 11 4796 8200      
Merck Sharp & Dohme Recruiting
North Ryde, Australia
Contact: Gary Jankelowitz    61 2 8988 8246      
MSD Belgium BVBA/SPRL Recruiting
Brussels, Belgium
Contact: Marc Denayer    32 2 776 60 28      
MSD Brasil Recruiting
Sao Paulo, Brazil
Contact: Ricardo Germano    55 11 51897942      
Canada, Quebec
Merck Canada Recruiting
Kirkland, Quebec, Canada, H9H 3L1
Contact: Medical Information Centre / Centre de l'information medicale de Merck Canada    514-428-8600 / 1-800-567-2594      
Merck Sharp & Dohme (I.A.) Corp. Recruiting
Santiago, Chile
Contact: Maria Elena Azara Hernandez    56 2 6558958      
Czech Republic
Merck Sharp and Dohme s.r.o. Recruiting
Praha, Czech Republic
Contact: Simona Martinkova    420 233010213      
Merck Sharp & Dohme Recruiting
Glostrup, Denmark
Contact: Gert Andersen    45 44824475      
MSD France Recruiting
Paris, France
Contact: Dominique Blazy    33 147548990      
Merck Sharp & Dohme GmbH Recruiting
Haar, Germany
Contact: German Medical Information Center    49 800 673 673 673      
Vianex, S.A. / MSD Recruiting
Alimos, Greece
Contact: Platon Peristaris    30 2109897322      
MSD Pharma Hungary Kft. Recruiting
Budapest, Hungary
Contact: Simona Martinkova    36 1 457 8522      
MSD Italia S.r.l. Recruiting
Rome, Italy
Contact: Patrizia Nardini    39 06 361911      
MSD K.K. Recruiting
Chiyoda-Ku, Tokyo, Japan, 102-8667
Contact: Japan Call Center    81-3-6272-1957      
Korea, Republic of
MSD Korea LTD Recruiting
Seoul, Korea, Republic of
Contact: Cem Ozesen    90 212 3361260      
Merck Sharp & Dohme BV Recruiting
Haarlem, Netherlands
Contact: Caroline Doornebos    31 23 515 3362      
Merck Sharp & Dohme Lda. Recruiting
Paco D'arcos, Portugal
Contact: Ana Maria Nogueira    351-21-4465890      
Russian Federation
Merck Sharp & Dohme IDEA, Inc. Recruiting
Moscow, Russian Federation
Contact: Tatiana Serebriakova    74959167100, EXT.366      
South Africa
MSD (Pty) LTD South Africa Recruiting
Midrand, South Africa
Contact: Khanyi Mzolo    27 11 655 3140      
Merck Sharp and Dohme de Espana S.A. Recruiting
Madrid, Spain
Contact: Joaquin Mateos Chacon    34913210428      
Merck Sharp & Dohme (I.A.) Corp. Recruiting
Taipei, Taiwan
Contact: Diana Zhang    886-2-66316030      
United Kingdom
Merck Sharp & Dohme Ltd. Recruiting
Hoddesdon, United Kingdom
Contact: Paul Robinson    44 1992452396      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01905657     History of Changes
Other Study ID Numbers: 3475-010, 2012-004391-19, 132355
Study First Received: July 18, 2013
Last Updated: February 25, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators processed this record on March 01, 2015