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History of Changes for Study: NCT02628067
Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)
Latest version (submitted May 9, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 9, 2015 None (earliest Version on record)
2 December 17, 2015 Conditions and Study Status
3 January 4, 2016 Recruitment Status, Study Status and Contacts/Locations
4 January 21, 2016 Study Status and Contacts/Locations
5 February 2, 2016 Study Status and Contacts/Locations
6 February 11, 2016 Contacts/Locations and Study Status
7 February 17, 2016 Contacts/Locations and Study Status
8 February 24, 2016 Contacts/Locations and Study Status
9 March 3, 2016 Study Status and Contacts/Locations
10 March 16, 2016 Contacts/Locations, Study Status and Study Identification
11 March 23, 2016 Study Status and Contacts/Locations
12 April 7, 2016 Contacts/Locations, Arms and Interventions, Study Status, Eligibility and Outcome Measures
13 April 12, 2016 Study Status
14 May 5, 2016 Contacts/Locations and Study Status
15 May 24, 2016 Eligibility and Study Status
16 June 2, 2016 Study Status and Contacts/Locations
17 June 16, 2016 Contacts/Locations and Study Status
18 June 22, 2016 Contacts/Locations and Study Status
19 June 28, 2016 Contacts/Locations and Study Status
20 July 15, 2016 Study Status and Contacts/Locations
21 July 22, 2016 Contacts/Locations and Study Status
22 August 3, 2016 Study Status and Contacts/Locations
23 August 25, 2016 Contacts/Locations and Study Status
24 October 4, 2016 Study Status and Contacts/Locations
25 October 13, 2016 Contacts/Locations and Study Status
26 November 10, 2016 Contacts/Locations and Study Status
27 November 18, 2016 Contacts/Locations and Study Status
28 January 2, 2017 Study Status
29 February 3, 2017 Contacts/Locations and Study Status
30 February 23, 2017 Study Status and Contacts/Locations
31 June 13, 2017 Study Status, Oversight, Contacts/Locations, Eligibility, Outcome Measures and Study Design
32 August 30, 2017 Study Status
33 September 21, 2017 Contacts/Locations and Study Status
34 October 10, 2017 Contacts/Locations, Study Status and Eligibility
35 November 17, 2017 Study Status
36 December 21, 2017 Study Status and Contacts/Locations
37 January 18, 2018 Study Status and Contacts/Locations
38 January 31, 2018 Contacts/Locations and Study Status
39 February 6, 2018 Study Status and Contacts/Locations
40 May 11, 2018 Contacts/Locations and Study Status
41 May 29, 2018 Contacts/Locations and Study Status
42 June 7, 2018 Contacts/Locations and Study Status
43 June 27, 2018 Contacts/Locations and Study Status
44 September 21, 2018 Study Status and Contacts/Locations
45 January 18, 2019 Study Status, IPDSharing and Contacts/Locations
46 March 8, 2019 Contacts/Locations and Study Status
47 May 22, 2019 Study Status and Contacts/Locations
48 July 18, 2019 Study Status and Contacts/Locations
49 December 19, 2019 Study Status, Arms and Interventions, References, Contacts/Locations, Eligibility, Outcome Measures, Study Design, Conditions, Study Description and Study Identification
50 December 27, 2019 Contacts/Locations and Study Status
51 January 27, 2020 Study Status and Contacts/Locations
52 February 14, 2020 Study Status, References and Contacts/Locations
53 May 14, 2020 Study Status and Contacts/Locations
54 July 26, 2020 Arms and Interventions, Study Design, Outcome Measures, Conditions, Study Status and Eligibility
55 September 23, 2020 Study Status and Contacts/Locations
56 November 5, 2020 Study Status and Contacts/Locations
57 December 16, 2020 Contacts/Locations and Study Status
58 February 19, 2021 Contacts/Locations and Study Status
59 March 2, 2021 Contacts/Locations and Study Status
60 April 30, 2021 Study Status and Contacts/Locations
61 June 23, 2021 Study Status and Eligibility
62 August 25, 2021 Study Status and Contacts/Locations
63 October 20, 2021 Study Status and Contacts/Locations
64 December 17, 2021 Study Status and Contacts/Locations
65 January 21, 2022 Study Status and Contacts/Locations
66 April 8, 2022 Contacts/Locations and Study Status
67 April 13, 2022 Contacts/Locations and Study Status
68 May 13, 2022 Study Status and Contacts/Locations
69 May 20, 2022 Contacts/Locations and Study Status
70 May 24, 2022 Contacts/Locations and Study Status
71 June 7, 2022 Study Status, Eligibility, Study Design and Study Identification
72 July 13, 2022 Contacts/Locations and Study Status
73 October 21, 2022 Outcome Measures, Study Status and Arms and Interventions
74 November 23, 2022 Study Status and Contacts/Locations
75 January 18, 2023 Outcome Measures, Study Status and Contacts/Locations
76 March 16, 2023 Study Status
77 May 5, 2023 Study Status and Contacts/Locations
78 May 19, 2023 Eligibility and Study Status
79 June 23, 2023 Study Status and Contacts/Locations
80 June 28, 2023 References and Study Status
81 November 2, 2023 Study Status and Contacts/Locations
82 November 23, 2023 Contacts/Locations and Study Status
83 December 28, 2023 Study Status and Contacts/Locations
84 February 2, 2024 Study Status and Contacts/Locations
85 April 4, 2024 Study Status and Contacts/Locations
86 April 26, 2024 Study Status
87 May 9, 2024 Study Status and Contacts/Locations
Comparison Format:

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Study NCT02628067
Submitted Date:  January 31, 2018 (v38)

Open or close this module Study Identification
Unique Protocol ID: 3475-158
Brief Title: Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)
Official Title: A Clinical Trial of Pembrolizumab (MK-3475) Evaluating Predictive Biomarkers in Subjects With Advanced Solid Tumors (KEYNOTE 158)
Secondary IDs: 2015-002067-41 [EudraCT Number]
163196 [Registry Identifier: JAPIC-CTI]
Open or close this module Study Status
Record Verification: January 2018
Overall Status: Recruiting
Study Start: December 18, 2015
Primary Completion: August 28, 2023 [Anticipated]
Study Completion: August 28, 2023 [Anticipated]
First Submitted: December 9, 2015
First Submitted that
Met QC Criteria:
December 9, 2015
First Posted: December 11, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 31, 2018
Last Update Posted: February 1, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Merck Sharp & Dohme LLC
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: Advanced Cancer
Keywords: PD1
PDL1
PD-1
PD-L1
MSI
microsatellite instability
MMR
mismatch repair
anal carcinoma
anal cancer
biliary adenocarcinoma
biliary cancer
cholangiocarcinoma
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
SCLC
mesothelioma
thyroid carcinoma
thyroid cancer
salivary gland carcinoma
salivary gland cancer
salivary cancer
parotid gland cancer
advanced solid tumors
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 1350 [Anticipated]
Open or close this module Arms and Interventions
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
  • KEYTRUDA®
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Objective Response Rate (ORR)
[ Time Frame: Up to 7.5 years ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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)
Open or close this module Contacts/Locations
Central Contact Person: Toll Free Number
Telephone: 1-888-577-8839
Study Officials: Medical Director
Study Director
Merck Sharp & Dohme LLC
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, Illinois
Call for Information (Investigational Site 0013)
[Recruiting]
Chicago, Illinois, United States, 60637
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, 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
Australia
Merck Sharp & Dohme
[Recruiting]
North Ryde, Australia
Contact:Contact: Australian Medical Information Centre 61 2 8988 8428
Brazil
MSD Brasil
[Recruiting]
Sao Paulo, Brazil
Contact:Contact: MSD Online 0800 012 22 32
Canada, Quebec
Merck Canada
[Recruiting]
Kirkland, Quebec, Canada, H9H 4M7
Contact:Contact: Medical Information Centre Centre d'information medicale Merck Canada Inc. 514-428-8600 / 1-800-567-2594
Colombia
MDS Colombia SAS
[Recruiting]
Bogota, Colombia
Contact:Contact: Francesca Carvajal 57 1219109011090
Denmark
Merck Sharp & Dohme
[Recruiting]
Glostrup, Denmark
Contact:Contact: Nathan Lassota 45 44824475
France
MSD France
[Recruiting]
Paris, France
Contact:Contact: Dominique Blazy 33 147548990
Germany
MSD Sharp & Dohme GmbH
[Recruiting]
Haar, Germany
Contact:Contact: German Medical Information Center 49 800 673 673 673
Israel
Merck Sharp & Dohme Co. Ltd.
[Recruiting]
Hod Hasharon, Israel
Contact:Contact: Gally Teper 972-9-9533310
Italy
MSD Italia S.r.l.
[Recruiting]
Rome, Italy
Contact:Contact: Patrizia Nardini 39 06 361911
Japan
MSD K.K.
[Recruiting]
Chiyoda-Ku, Tokyo, Japan, 102-8667
Contact:Contact: Japan Call Center 81-3-6272-1957
Korea, Republic of
MSD Korea LTD
[Recruiting]
Seoul, Korea, Republic of, 4130
Contact:Contact: Jongho Ahn 82-2-331-2000 2015
Mexico
MSD
[Recruiting]
Mexico City, Mexico
Contact:Contact: Juan Marques 52 55254819608
Netherlands
Merck Sharp & Dohme BV
[Recruiting]
Haarlem, Netherlands
Contact:Contact: Caroline Doornebos 31 23 515 3362
Norway
MSD Norge A/S
[Recruiting]
Drammen, Norway
Contact:Contact: Tony Johansson 47 32 20 75 20
Philippines
Merck Sharp & Dohme (I.A.) Corporation
[Recruiting]
Makati, Philippines
Contact:Contact: Cesar Recto 632 784 9500
Russian Federation
Merck Sharp & Dohme IDEA, Inc.
[Recruiting]
Moscow, Russian Federation
Contact:Contact: Tatiana Serebriakova 74959167100, EXT.366
South Africa
MSD (Pty) LTD South Africa
[Recruiting]
Midrand, South Africa
Contact:Contact: Khanyi Mzolo 27 11 655 3140
Spain
Merck Sharp and Dohme de Espana S.A.
[Recruiting]
Madrid, Spain
Contact:Contact: Joaquin Mateos Chacon (0034) 913210600
Taiwan
Merck Sharp & Dohme (I.A.) Corp.
[Recruiting]
Taipei, Taiwan
Contact:Contact: I-Hua Su 886-2-66316000
United Kingdom
Merck Sharp & Dohme Ltd.
[Recruiting]
Hoddesdon, United Kingdom
Contact:Contact: Mark Toms +44 (0) 1992 452475
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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