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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.
See Contacts and Locations
Verified June 2017 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT02628067
First received: December 9, 2015
Last updated: June 13, 2017
Last verified: June 2017
  Purpose
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: No masking
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
  • KEYTRUDA®

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02628067

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

  Show 43 Study Locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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 )
Study First Received: December 9, 2015
Last Updated: June 13, 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.:
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

Additional relevant MeSH terms:
Pembrolizumab
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 26, 2017