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Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)

This study is currently recruiting participants.
Verified November 2017 by Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
First Posted: December 11, 2015
Last Update Posted: November 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
In this study, participants with multiple types of advanced (unresectable and/or metastatic) solid tumors that have progressed on standard of care therapy will be treated with pembrolizumab.

Condition Intervention Phase
Advanced Cancer Biological: pembrolizumab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Trial of Pembrolizumab (MK-3475) Evaluating Predictive Biomarkers in Subjects With Advanced Solid Tumors (KEYNOTE 158)

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Objective Response Rate (ORR) [ Time Frame: Up to 7.5 years ]

Estimated Enrollment: 1350
Actual Study Start Date: December 18, 2015
Estimated Study Completion Date: August 28, 2023
Estimated Primary Completion Date: August 28, 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pembrolizumab
Participants receive pembrolizumab 200 mg intravenously every 3 weeks (Q3W) for up to 35 administrations (approximately 2 years of treatment)
Biological: pembrolizumab
intravenous infusion
Other Names:
  • MK-3475


Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically-documented, advanced solid tumor of one of the following types:

    • Anal Squamous Cell Carcinoma
    • Biliary Adenocarcinoma (gallbladder or biliary tree (intrahepatic or extrahepatic cholangiocarcinoma) except Ampulla of Vater cancers)
    • Neuroendocrine Tumors (well- and moderately-differentiated) of the lung, appendix, small intestine, colon, rectum, or pancreas
    • Endometrial Carcinoma (sarcomas and mesenchymal tumors are excluded)
    • Cervical Squamous Cell Carcinoma
    • Vulvar Squamous Cell Carcinoma
    • Small Cell Lung Carcinoma
    • Mesothelioma
    • Thyroid Carcinoma
    • Salivary Gland Carcinoma (sarcomas and mesenchymal tumors are excluded)
    • OR
    • Any advanced solid tumor, with the exception of colorectal carcinoma (CRC), which is Microsatellite Instability (MSI)-High (MSI-H)
  • Progression of tumor or intolerance to therapies known to provide clinical benefit. There is no limit to the number of prior treatment regimens
  • Can supply tumor tissue for study analyses (dependent on tumor type)
  • Radiologically-measurable disease
  • Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 3 days prior to first dose of pembrolizumab
  • Life expectancy of at least 3 months
  • Adequate organ function
  • Female participants of childbearing potential must be willing to use adequate contraception for the course of the study through 120 days after the last dose of study medication
  • Male participants with partners of must childbearing potential must be willing to use adequate contraception for the course of the study through 120 days after the last dose of study medication

Exclusion Criteria:

  • Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of study medication
  • Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication
  • Active autoimmune disease that has required systemic treatment in the past 2 years
  • Prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or not recovered from an adverse event caused by mAbs administered more than 4 weeks earlier
  • Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks of study Day 1 or not recovered from adverse events caused by a previously administered agent
  • Known additional malignancy within 2 years prior to enrollment with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cancers
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has known glioblastoma multiforme of the brainstem
  • History of non-infectious pneumonitis that required steroids or current pneumonitis
  • Active infection requiring systemic therapy
  • Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
  • Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study medication
  • Previously participated in any other pembrolizumab (MK-3475) study, or received prior therapy with an anti-programmed cell death (PD)-1, anti-PD-Ligand 1 (anti-PD-L1), anti-PD-L2, or any other immunomodulating mAb or drug specifically targeting T-cell co-stimulation or checkpoint pathways
  • Known history of Human Immunodeficiency Virus (HIV)
  • Known active Hepatitis B or C
  • Received live vaccine within 30 days of planned start of study medication
  • Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
  • Known history of active tuberculosis (TB, Bacillus tuberculosis)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02628067

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

  Hide Study Locations
United States, California
Call for Information (Investigational Site 0018) Recruiting
Duarte, California, United States, 91010
Call for Information (Investigational Site 0202) Recruiting
Los Angeles, California, United States, 90033
Call for Information (Investigational Site 0017) Recruiting
Los Angeles, California, United States, 90048
Call for Information (Investigational Site 0006) Recruiting
San Francisco, California, United States, 94143-1711
United States, Colorado
Call for Information (Investigational Site 0203) Recruiting
Aurora, Colorado, United States, 80045
United States, Florida
Call for Information (Investigational Site 0015) Recruiting
Orlando, Florida, United States, 32806
Call for Information (Investigational Site 0014) Recruiting
Tampa, Florida, United States, 33612
United States, Georgia
Call for Information (Investigational Site 0205) Recruiting
Atlanta, Georgia, United States, 30303
United States, Illinois
Call for Information (Investigational Site 0013) Recruiting
Chicago, Illinois, United States, 60637
United States, Indiana
Call for Information (Investigational Site 0007) Recruiting
Indianapolis, Indiana, United States, 46202
United States, Maryland
Call for Information (Investigational Site 0011) Recruiting
Baltimore, Maryland, United States, 21231
Call for Information (Investigational Site 0208) Recruiting
Bethesda, Maryland, United States, 20889
Call for Information (Investigational Site 0005) Recruiting
Rockville, Maryland, United States, 20850
United States, Massachusetts
Call for Information (Investigational Site 0207) Recruiting
Boston, Massachusetts, United States, 02114
Call for Information (Investigational Site 0010) Recruiting
Boston, Massachusetts, United States, 02215
Call for Information (Investigational Site 0209) Recruiting
Boston, Massachusetts, United States, 02215
United States, Minnesota
Call for Information (Investigational Site 0206) Recruiting
Rochester, Minnesota, United States, 55905
United States, New Jersey
Call for Information (Investigational Site 0008) Recruiting
New Brunswick, New Jersey, United States, 08903
United States, New Mexico
Call for Information (Investigational Site 0204) Recruiting
Albuquerque, New Mexico, United States, 87131-0001
United States, Ohio
Call for Information (Investigational Site 0200) Recruiting
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Call for Information (Investigational Site 0001) Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Call for Information (Investigational Site 0004) Recruiting
Houston, Texas, United States, 77030
United States, Virginia
Call for Information (Investigational Site 0213) Recruiting
Midlothian, Virginia, United States, 23114
Merck Sharp & Dohme Recruiting
North Ryde, Australia
Contact: Australian Medical Information Centre    61 2 8988 8428      
MSD Brasil Recruiting
Sao Paulo, Brazil
Contact: MSD Online    0800 012 22 32      
Canada, Quebec
Merck Canada Recruiting
Kirkland, Quebec, Canada, H9H 4M7
Contact: Medical Information Centre Centre d'information medicale Merck Canada Inc.    514-428-8600 / 1-800-567-2594      
MDS Colombia SAS Recruiting
Bogota, Colombia
Contact: Francesca Carvajal    57 1219109011090      
Merck Sharp & Dohme Recruiting
Glostrup, Denmark
Contact: Nathan Lassota    45 44824475      
MSD France Recruiting
Paris, France
Contact: Dominique Blazy    33 147548990      
MSD Sharp & Dohme GmbH Recruiting
Haar, Germany
Contact: German Medical Information Center    49 800 673 673 673      
Merck Sharp & Dohme Co. Ltd. Recruiting
Hod Hasharon, Israel
Contact: Gally Teper    972-9-9533310      
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, 4130
Contact: Jongho Ahn    82-2-331-2000 2015      
MSD Recruiting
Mexico City, Mexico
Contact: Juan Marques    52 55254819608      
Merck Sharp & Dohme BV Recruiting
Haarlem, Netherlands
Contact: Caroline Doornebos    31 23 515 3362      
MSD Norge A/S Recruiting
Drammen, Norway
Contact: Tony Johansson    47 32 20 75 20      
Merck Sharp & Dohme (I.A.) Corporation Recruiting
Makati, Philippines
Contact: Cesar Recto    632 784 9500      
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    (0034) 913210600      
Merck Sharp & Dohme (I.A.) Corp. Recruiting
Taipei, Taiwan
Contact: I-Hua Su    886-2-66316000      
United Kingdom
Merck Sharp & Dohme Ltd. Recruiting
Hoddesdon, United Kingdom
Contact: Mark Toms    +44 (0) 1992 452475      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02628067     History of Changes
Other Study ID Numbers: 3475-158
2015-002067-41 ( EudraCT Number )
163196 ( Registry Identifier: JAPIC-CTI )
First Submitted: December 9, 2015
First Posted: December 11, 2015
Last Update Posted: November 20, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Merck Sharp & Dohme Corp.:
microsatellite instability
mismatch repair
anal carcinoma
anal cancer
biliary adenocarcinoma
biliary cancer
bile duct cancer
neuroendocrine tumor
carcinoid tumor
endometrial carcinoma
endometrial cancer
cervical carcinoma
cervical cancer
vulvar carcinoma
vulvar cancer
small cell lung carcinoma
small cell lung cancer
thyroid carcinoma
thyroid cancer
salivary gland carcinoma
salivary gland cancer

Additional relevant MeSH terms:
Antineoplastic Agents