This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Study of Pembrolizumab (MK-3475) in Previously-Treated Participants With Advanced Carcinoma of the Esophagus or Esophagogastric Junction (MK-3475-180/KEYNOTE-180)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT02559687
First received: September 23, 2015
Last updated: June 5, 2017
Last verified: June 2017
  Purpose
In this study participants with advanced/metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type I adenocarcinoma of the gastroesophageal junction (GEJ) previously treated with two standard therapies will be treated with pembrolizumab

Condition Intervention Phase
Esophageal Carcinoma Esophagogastric Junction Carcinoma Biological: pembrolizumab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase II Study of Pembrolizumab Monotherapy in Third-line Previously Treated Subjects With Advanced/Metastatic Adenocarcinoma or Squamous Cell Carcinoma of the Esophagus or Advanced/Metastatic Siewert Type I Adenocarcinoma of the Esophagogastric Junction (KEYNOTE -180)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: Up to 2 years ]

Estimated Enrollment: 100
Actual Study Start Date: December 2, 2015
Estimated Study Completion Date: March 18, 2019
Estimated Primary Completion Date: September 26, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pembrolizumab
Participants receive pembrolizumab 200 mg, intravenously (IV), every 3 weeks (Q3W) for up to 35 treatments (approximately 2 years)
Biological: pembrolizumab
IV Q3W
Other Name: MK-3475

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy greater than 3 months
  • Histologically-proven advanced/metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the EGJ
  • Documented objective radiographic or clinical disease progression on two previous lines of standard therapy
  • Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
  • Can provide either a newly obtained or archival tumor tissue sample for intratumoral immune-related testing and for anti-programmed cell death (PD-1)
  • 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 must agree to use adequate contraception starting with the first dose through 120 days after the last dose of study medication
  • Adequate organ function

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
  • Has active autoimmune disease that has required systemic treatment within the 2 years prior to 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
  • Known central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Prior anti-cancer mAb, chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to first dose of study medication or not recovered from adverse events due to a previously administered agent
  • Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1), or anti-PD-L2 agent, or previously participated in a Merck pembrolizumab (MK-3475) study
  • Has a known additional malignancy that has progressed or required active treatment within the last 5 years with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, in-situ cervical cancer, and in-situ or intra-mucosal pharyngeal cancer
  • Received a live vaccine within 30 days of the first dose of study medication
  • Known history of Human Immunodeficiency Virus (HIV) infection
  • Known active Hepatitis B or C
  • 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
  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: NCT02559687

  Hide Study Locations
Locations
United States, California
Call for Information (Investigational Site 8010)
Santa Barbara, California, United States, 93105
United States, Colorado
Call for Information (Investigational Site 8009)
Parker, Colorado, United States, 80138
United States, Connecticut
Call for Information (Investigational Site 0232)
Norwich, Connecticut, United States, 06360
United States, Florida
Call for Information (Investigational Site 8018)
Ocala, Florida, United States, 34471
United States, Hawaii
Call for Information (Investigational Site 0001)
Honolulu, Hawaii, United States, 96813
United States, Illinois
Call for Information (Investigational Site 0009)
Maywood, Illinois, United States, 60153
United States, Iowa
Call for Information (Investigational Site 0020)
Iowa City, Iowa, United States, 52242
United States, Michigan
Call for Information (Investigational Site 0234)
Detroit, Michigan, United States, 48201
Call for Information (Investigational Site 0019)
Detroit, Michigan, United States, 48202
United States, Minnesota
Call for Information (Investigational Site 8005)
Edina, Minnesota, United States, 55435
United States, Missouri
Call for Information (Investigational Site 0024)
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Call for Information (Investigational Site 0002)
Hackensack, New Jersey, United States, 07601
United States, New York
Call for Information (Investigational Site 8015)
Johnson City, New York, United States, 13790
Call for Information (Investigational Site 0231)
New York, New York, United States, 10021
Call for Information (Investigational Site 0235)
Rochester, New York, United States, 14620
United States, Ohio
Call for Information (Investigational Site 0004)
Columbus, Ohio, United States, 43221
United States, Pennsylvania
Call for Information (Investigational Site 0224)
Allentown, Pennsylvania, United States, 18106
Call for Information (Investigational Site 0254)
Hershey, Pennsylvania, United States, 17033
United States, South Dakota
Call for Information (Investigational Site 0227)
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
Call for Information (Investigational Site 0021)
Nashville, Tennessee, United States, 37208
United States, Texas
Call for Information (Investigational Site 8007)
Austin, Texas, United States, 78731
Call for Information (Investigational Site 8003)
Dallas, Texas, United States, 75231
Call for Information (Investigational Site 8012)
Denton, Texas, United States, 76210
Call for Information (Investigational Site 8022)
Fort Worth, Texas, United States, 76104
United States, Virginia
Call for Information (Investigational Site 0006)
Fairfax, Virginia, United States, 22031
Japan
MSD K.K.
Chiyoda-Ku, Tokyo, Japan, 102-8667
Korea, Republic of
MSD Korea LTD
Seoul, Korea, Republic of, 4130
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02559687     History of Changes
Other Study ID Numbers: 3475-180
2015-002427-26 ( EudraCT Number )
163188 ( Registry Identifier: JAPIC-CTI )
Study First Received: September 23, 2015
Last Updated: June 5, 2017

Keywords provided by Merck Sharp & Dohme Corp.:
PD1
PD-L1
PDL1

Additional relevant MeSH terms:
Carcinoma
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Pembrolizumab
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 14, 2017