Pembrolizumab in Refractory Advanced Esophageal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02971956|
Recruitment Status : Not yet recruiting
First Posted : November 23, 2016
Last Update Posted : December 8, 2016
This research study is studying a targeted therapy as a possible treatment for advanced esophageal cancer.
The study intervention involved in this study is:
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer Squamous Cell Esophagus Cancer Adenocarcinoma Esophagus||Drug: Pembrolizumab||Phase 2|
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved Pembrolizumab for the participant specific disease but it has been approved for other uses.
Pembrolizumab, also known as KEYTRUDA or MK-3475, is approved in the USA and several other countries to treat other types of diseases.
The goal of this research study is to
-Evaluate the safety and efficacy of pembrolizumab in participants with advanced esophageal cancer that have not responded to standard treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Pembrolizumab in Refractory Advanced Esophageal Cancer|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2024|
Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
Other Name: Keytruda
- Major Response Rate (CR + PR) Of Patients With Refractory Esophageal Adenocarcinoma To Pembrolizumab [ Time Frame: 2 years ]Evaluate the response rate, by irRECIST, of pembrolizumab in refractory, advanced esophageal adenocarcinoma patients.
- Complete Response Rate [ Time Frame: 2 years ]Evaluate the response rate, by irRECIST, of pembrolizumab in refractory, advanced esophageal adenocarcinoma patients.
- Partial Response Rate [ Time Frame: 2 years ]Evaluate the response rate, by irRECIST, of pembrolizumab in refractory, advanced esophageal adenocarcinoma patients.
- Overall Survival [ Time Frame: 2 years ]Overall Survival (OS) is defined as the time from registration to death due to any cause, or censored at date last known alive. OS will be measured by the Method of Kaplan and Meier.
- Progression-Free Survival [ Time Frame: 2 years ]Progression-Free Survival (PFS) is defined as the time from registration to the earlier of progression or death due to any cause. PFS will be measured by the Method of Kaplan and Meier.
- Evaluate The Durability Of Pembrolizumab Response In Advanced Esophageal Cancer Patients [ Time Frame: 2 years ]Evaluate the durability of pembrolizumab response in advanced esophageal cancer patients by measuring median overall survival and median progression free survival.Progression-free Survival (PFS) and Overall Survival (OS) as measured by the Method of Kaplan and Meier.
- Evaluate The Safety And Tolerability Of Pembrolizumab 200 Mg, Administered Every Three Weeks, In Advanced Esophageal Cancer. [ Time Frame: 2 years ]Evaluate the safety and tolerability of pembrolizumab 200 mg, administered every three weeks, in advanced esophageal cancer. A full physical exam will be performed before the start of each cycle. Adverse events, ECOG performance status, and laboratory assessments will be performed regularly.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02971956
|Contact: Peter C. Enzinger, MD||617-632-6855||Peter_Enzinger@dfci.harvard.edu|
|United States, Massachusetts|
|Massachusetts General Hospital||Not yet recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Justin Gainor, MD 617-724-4000|
|Principal Investigator: Justin Gainor, MD|
|Beth Israel Deaconess Medical Center||Not yet recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Rebecca Miksad, MD 617-667-4827|
|Principal Investigator: Rebecca Miksad, MD|
|Dana Farber Cancer Institute||Not yet recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Peter C. Enzinger, MD 617-632-6855 Peter_Enzinger@dfci.harvard.edu|
|Principal Investigator: Peter C. Enzinger, MD|
|Principal Investigator:||Peter C. Enzinger, MD||Dana-Farber Cancer Institute|