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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:
Merck Sharp & Dohme Corp.
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
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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:
MedlinePlus related topics:
Esophageal Cancer
Drug Information available for:
Pembrolizumab
U.S. FDA Resources
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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02559687
Show 27 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02559687
Show 27 Study Locations
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