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
History of Changes
September 23, 2015
June 5, 2017
December 2, 2015
September 26, 2017   (Final data collection date for primary outcome measure)
Objective Response Rate [ Time Frame: Up to 2 years ]
Overall Response Rate [ Time Frame: Up to 2 years ]
Complete list of historical versions of study NCT02559687 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of Pembrolizumab (MK-3475) in Previously-Treated Participants With Advanced Carcinoma of the Esophagus or Esophagogastric Junction (MK-3475-180/KEYNOTE-180)
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)
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
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
  • Esophageal Carcinoma
  • Esophagogastric Junction Carcinoma
Biological: pembrolizumab
IV Q3W
Other Name: MK-3475
Experimental: Pembrolizumab
Participants receive pembrolizumab 200 mg, intravenously (IV), every 3 weeks (Q3W) for up to 35 treatments (approximately 2 years)
Intervention: Biological: pembrolizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
March 18, 2019
September 26, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan,   Korea, Republic of,   United States
Australia,   Denmark,   France,   Germany,   Norway,   United Kingdom
 
NCT02559687
3475-180
2015-002427-26 ( EudraCT Number )
163188 ( Registry Identifier: JAPIC-CTI )
No
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
June 2017

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