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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:  December 9, 2015 (v1)
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]
Open or close this module Study Status
Record Verification: December 2015
Overall Status: Not yet recruiting
Study Start: January 2016
Primary Completion: April 2018 [Anticipated]
Study Completion: April 2018 [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:		 December 9, 2015
Last Update Posted: December 11, 2015 [Estimate]
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:
U.S. FDA-regulated Device:
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
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: 1100 [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
Other Names:
  • MK-3475
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Objective Response Rate (ORR)
[ Time Frame: Up to 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 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 Carcinoma
    • Vulvar Carcinoma
    • Small Cell Lung Carcinoma
    • Mesothelioma
    • Thyroid Carcinoma
    • Salivary Gland Carcinoma (sarcomas and mesenchymal tumors are excluded)
    • OR
    • Any other 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
  • 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 cervical and/or in situ breast cancers
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Evidence of active non-infectious 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 (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
Open or close this module Contacts/Locations
Study Officials: Medical Director
Study Director
Merck Sharp & Dohme LLC
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services