Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975)
This important study is investigating a new treatment called pembrolizumab for certain types of oesophageal cancer. Patients taking part will either receive pembrolizumab or a dummy drug (placebo), along with the usual chemotherapy and radiotherapy. The main goal is to see if adding pembrolizumab can improve how long people live or how long they stay free of the cancer. Researchers are particularly interested in patients whose cancer cells have a specific marker called PD-L1, but all patients with this type of oesophageal cancer are included. This research aims to find out if this combination therapy is more effective than current standard care, offering hope for better treatment options in the future.
At a glance
What is this study about?
This study is about people who have a type of cancer that affects the gullet (oesophagus) or the area where the gullet meets the stomach. This includes specific types such as oesophageal squamous cell carcinoma or oesophageal adenocarcinoma. When you have this type of cancer, doctors might suggest a treatment plan that involves using special X-rays to target the cancer (radiotherapy) and medicines that kill cancer cells (chemotherapy).
In this study, researchers are looking at whether adding a new drug called pembrolizumab to this standard treatment can make it more effective. Pembrolizumab is a type of immunotherapy, which essentially helps your body's own immune system fight the cancer. Some people in the study will get pembrolizumab, while others will get a 'placebo' – a treatment that looks like pembrolizumab but doesn't contain any active drug. This allows the researchers to fairly compare the two groups and see if pembrolizumab really makes a difference.
The main things the researchers want to find out are whether people who receive pembrolizumab live longer, or stay free of their cancer for a longer period. They are particularly interested in how treatment works for people whose cancer cells have a certain marker called PD-L1, but they will also look at the results for everyone in the study. The hope is that this new combination of treatments could lead to better outcomes for people with this kind of cancer.
Key takeaways
- This study evaluates a new drug, pembrolizumab, for oesophageal cancer.
- It compares pembrolizumab plus standard treatment to a placebo plus standard treatment.
- The main goals are to see if the new treatment helps people live longer or keeps cancer away longer.
- Participation involves regular hospital visits, treatments, and tests for about a year.
- You might receive the new drug or a dummy drug, and you can leave the study at any time.
Who may be eligible?
To join this study, your doctor needs to confirm you have oesophageal cancer, specifically squamous cell carcinoma, adenocarcinoma, or gastroesophageal junction carcinoma. The cancer should not have spread to distant parts of your body, and your general health should be good enough to handle the treatments. Your medical team will decide if this study is right for you, especially if surgery isn't the best option for your cancer at this time.
You also need to be able to complete the full course of treatment which can last for about a year. Both men and women can join. If you're a woman who could become pregnant, or a man whose partner could become pregnant, you'll need to use effective contraception during the study and for a period afterwards to prevent pregnancy.
There are some reasons why you might not be able to join. For example, if your cancer has grown into major blood vessels or other organs nearby, or if you've had major surgery very recently. You also can't be pregnant or breastfeeding. Your doctor will review all your medical information carefully to see if this study is a good fit for you.
- Do I have oesophageal cancer (squamous cell, adenocarcinoma, or gastroesophageal junction)?
- Has my doctor said surgery isn't the main treatment for me right now?
- Am I generally well enough to go through chemotherapy and radiotherapy?
- Am I able to use effective birth control if needed?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to join this study, you will receive standard chemotherapy and radiotherapy for your oesophageal cancer, just like you would usually. In addition to this, you will also receive either the study drug, pembrolizumab, or a placebo (a dummy drug). You won't know which one you are getting, and neither will your doctor, which helps to keep the study fair. The chemotherapy will involve either two or three different drugs given together. All these treatments will be given over approximately one year.
During this time, you will have regular visits to the hospital for your treatments, check-ups, and tests. These tests will help the doctors monitor your health, how the treatment is affecting you, and how your cancer is responding. These might include blood tests, scans, and other medical examinations. You will continue to be monitored for some time after your treatment finishes to see how you are doing in the long term.
Potential risks and benefits
Locations (170)
- MemorialCare Health System - Long Beach Medical Center-Oncology ( Site 0691)Long Beach, United States
- Columbus Regional Research Institute ( Site 0047)Columbus, United States
- University of Kansas Cancer Center ( Site 0023)Westwood, United States
- Cancer Center of Kansas ( Site 0058)Wichita, United States
- University Medical Center ( Site 0035)New Orleans, United States
- Greater Baltimore Medical Center ( Site 0031)Baltimore, United States
- Dana Farber Cancer Center ( Site 0034)Boston, United States
- Henry Ford Hospital ( Site 0685)Detroit, United States
- University of Missouri ( Site 0688)Columbia, United States
- Renown Regional Medical Center ( Site 0706)Reno, United States
- Rutgers Cancer Institute of New Jersey ( Site 0695)New Brunswick, United States
- Weill Cornell Medical College ( Site 0053)New York, United States
+158 more sites — see the official record for the full list.
Common questions
What is oesophageal cancer?
Oesophageal cancer is a serious illness that starts in the tube (gullet) that carries food from your throat to your stomach.
What is pembrolizumab?
Pembrolizumab is a type of medicine that helps your body’s own defence system (immune system) fight against cancer cells.
What is a placebo?
A placebo is a substance that looks exactly like the study drug but doesn't contain any active medicine. It helps compare the new drug fairly.
Will I still receive my normal cancer treatment?
Yes, everyone in the study will receive standard chemotherapy and radiotherapy for their cancer, which is the usual treatment currently.
Do I have to pay to be in the study?
No, all treatments and tests directly related to the study will be provided at no cost to you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.