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

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. Identifier: NCT02628067
Recruitment Status : Recruiting
First Posted : December 11, 2015
Last Update Posted : September 24, 2018
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Advanced Cancer Biological: pembrolizumab Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1350 participants
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)
Actual Study Start Date : December 18, 2015
Estimated Primary Completion Date : August 28, 2023
Estimated Study Completion Date : August 28, 2023

Arm Intervention/treatment
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)

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 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 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, 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, Texas
Call for Information (Investigational Site 0004) Recruiting
Houston, Texas, United States, 77030
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: Liliana Ferro    57 12191093      
Merck Sharp & Dohme Recruiting
Glostrup, Denmark
Contact: Katrin Moeschlin    46857813545      
MSD France Recruiting
Paris, France
Contact: Valerie Bouchara    33 180464417      
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: Dan Goldstaub    972-9-9533326      
MSD Italia S.r.l. Recruiting
Rome, Italy
Contact: Paola Chiaretta Fattore    39 0636191739      
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: TaeYoun Jo    8223312313      
MSD Recruiting
Mexico City, Mexico
Contact: Alexandra Barajas    52 5554819650      
Merck Sharp & Dohme BV Recruiting
Haarlem, Netherlands
Contact: Arjan Ooms    31235153306      
MSD Norge A/S Recruiting
Drammen, Norway
Contact: Katrin Moeschlin    46857813545      
Merck Sharp & Dohme (I.A.) Corporation Recruiting
Makati, Philippines
Contact: Georgina Arnold    61289888212      
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: Zoe Nell    27 116553307      
Merck Sharp and Dohme de Espana S.A. Recruiting
Madrid, Spain
Contact: Lourdes Lopez-Bravo    (0034) 913210654      
Merck Sharp & Dohme (I.A.) Corp. Recruiting
Taipei, Taiwan
Contact: Keris Huang    886 266316032      
United Kingdom
Merck Sharp & Dohme Ltd. Recruiting
Hoddesdon, United Kingdom
Contact: Paul Duffy    44 01992455265      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Director Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT02628067     History of Changes
Other Study ID Numbers: 3475-158
2015-002067-41 ( EudraCT Number )
163196 ( Registry Identifier: JAPIC-CTI )
First Posted: December 11, 2015    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018

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