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

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ClinicalTrials.gov Identifier: NCT02628067
Recruitment Status : Recruiting
First Posted : December 11, 2015
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE December 9, 2015
First Posted Date  ICMJE December 11, 2015
Last Update Posted Date March 11, 2019
Actual Study Start Date  ICMJE December 18, 2015
Estimated Primary Completion Date August 28, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2017)
Objective Response Rate (ORR) [ Time Frame: Up to 7.5 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 9, 2015)
Objective Response Rate (ORR) [ Time Frame: Up to 5 years ]
Change History Complete list of historical versions of study NCT02628067 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)
Official Title  ICMJE A Clinical Trial of Pembrolizumab (MK-3475) Evaluating Predictive Biomarkers in Subjects With Advanced Solid Tumors (KEYNOTE 158)
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Cancer
Intervention  ICMJE Biological: pembrolizumab
intravenous infusion
Other Names:
  • MK-3475
  • KEYTRUDA®
Study Arms  ICMJE Experimental: Pembrolizumab
Participants receive pembrolizumab 200 mg intravenously every 3 weeks (Q3W) for up to 35 administrations (approximately 2 years of treatment)
Intervention: Biological: pembrolizumab
Publications * Chung HC, Ros W, Delord JP, Perets R, Italiano A, Shapira-Frommer R, Manzuk L, Piha-Paul SA, Xu L, Zeigenfuss S, Pruitt SK, Leary A. Efficacy and Safety of Pembrolizumab in Previously Treated Advanced Cervical Cancer: Results From the Phase II KEYNOTE-158 Study. J Clin Oncol. 2019 Apr 3:JCO1801265. doi: 10.1200/JCO.18.01265. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 13, 2017)
1350
Original Estimated Enrollment  ICMJE
 (submitted: December 9, 2015)
1100
Estimated Study Completion Date  ICMJE August 28, 2023
Estimated Primary Completion Date August 28, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Toll Free Number 1-888-577-8839
Listed Location Countries  ICMJE Australia,   Brazil,   Canada,   Colombia,   Denmark,   France,   Germany,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Norway,   Philippines,   Russian Federation,   South Africa,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02628067
Other Study ID Numbers  ICMJE 3475-158
2015-002067-41 ( EudraCT Number )
163196 ( Registry Identifier: JAPIC-CTI )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP