Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06)
Researchers are exploring better treatments for a type of oesophageal cancer called squamous cell carcinoma, which has spread or can't be fully removed. Current treatments include pembrolizumab (an immunotherapy that helps your body fight cancer) and chemotherapy. This study aims to combine pembrolizumab with new experimental drugs, sometimes alongside chemotherapy. One experimental drug, Ifinatamab deruxtecan (I-DXd), is designed to target cancer cells specifically. The main goals are to see if these combinations are safe and well-tolerated, and to find out how effectively they shrink or get rid of the cancer. Participants must be at least 18 years old.
At a glance
What is this study about?
This study is being done to find new and improved ways to treat a specific type of oesophageal cancer called oesophageal squamous cell carcinoma. This cancer starts in the lining of the oesophagus, which is the tube connecting your throat to your stomach. We are focusing on cancers that are either locally advanced (meaning they have grown into nearby tissues and can't be completely removed by surgery) or metastatic (meaning they have spread to other parts of the body). Currently, common treatments for these advanced cancers include pembrolizumab, which is an immunotherapy that helps your own immune system fight the cancer, and chemotherapy, which uses strong medicines to kill cancer cells.
In this study, doctors want to see what happens when they combine pembrolizumab with other new, experimental medicines, sometimes with or without standard chemotherapy. One of these experimental medicines is called Ifinatamab deruxtecan (I-DXd). This drug is designed like a smart bomb: it has a part that finds and attaches to specific proteins on cancer cells, and then delivers a powerful medicine directly to destroy those cells, hopefully sparing healthy ones.
The main reasons for doing this study are to make sure these new treatment combinations are safe for people and that patients can tolerate them without too many severe side effects. Researchers will also carefully watch to see how the cancer responds to the treatments – for example, if it gets smaller, stops growing, or even disappears. This information will help doctors understand if these new combinations could become better treatment options in the future.
Key takeaways
- This study explores new combinations of medicines for advanced oesophageal cancer.
- It combines an existing immunotherapy (pembrolizumab) with new experimental drugs, sometimes with chemotherapy.
- Main goals are to check safety, how well patients tolerate the new treatments, and if the cancer shrinks.
- This is for oesophageal squamous cell carcinoma that has spread or can't be removed by surgery.
- You'll get regular check-ups and monitoring if you join.
- Participation contributes to finding better treatments for future patients.
Who may be eligible?
To join this study, people generally need to have been diagnosed with oesophageal squamous cell carcinoma that is either advanced (cannot be removed by surgery) or has spread to other parts of the body. You must not have received other systemic (body-wide) cancer treatment for this advanced oesophageal cancer before. The doctors will need to see that your cancer can be measured, meaning they can track how it's responding to treatment.
Your general health is important too. You should be in reasonably good health, with your body organs working properly, and any side effects from previous cancer treatments (like surgery or radiation) should have mostly cleared up. If you have HIV, it needs to be well-managed with medication.
There are also some reasons why you might not be able to join. For example, if your tumour is too close to critical organs like the main blood vessel (aorta) or airways, or if you have severe fluid build-up around your lungs or heart. People with certain serious eye problems or those who have previously received specific types of immunotherapy for this cancer would also not be able to take part. The study is open to adults aged 18 and over.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years or older?
- Do you have oesophageal squamous cell carcinoma that is advanced or has spread?
- Have you NOT received other body-wide (systemic) treatments for this advanced cancer yet?
- Is your general health reasonably good, with organs working well?
- Are any side effects from your past cancer treatments mostly gone?
What does participation involve?
Taking part in this study would involve regular visits to the clinic for assessments and to receive your study medication. These visits will likely include physical examinations, blood tests, and scans (like CT scans) to check how the cancer is responding and to monitor for any side effects. You will receive one or more medications, including pembrolizumab and/or an investigational drug, potentially with chemotherapy. The specific schedule and duration of treatment will depend on which study group you are in and how you respond to the treatment. You will be closely monitored by the study team throughout your participation, and there will be follow-up appointments even after treatment ends. The total duration of your participation, including follow-up, could extend over many months or even longer.
Potential risks and benefits
Locations (42)
- UPMC Hillman Cancer Center ( Site 1904)Verified postcodePittsburgh, United States· Recruiting
- Liga Norte Riograndense Contra o Cancer ( Site 1301)Verified postcodeNatal, Brazil· Recruiting
- Hospital Nossa Senhora da Conceicao ( Site 1300)Verified postcodePorto Alegre, Brazil· Recruiting
- Clínica Puerto Montt ( Site 1406)Verified postcodePort Montt, Chile· Recruiting
- FALP ( Site 1400)Verified postcodeSantiago, Chile· Recruiting
- Centro de Oncología de Precisión ( Site 1402)Verified postcodeSantiago, Chile· Recruiting
- Clínica UC San Carlos de Apoquindo ( Site 1403)Verified postcodeSantiago, Chile· Recruiting
- Bradfordhill ( Site 1401)Verified postcodeSantiago, Chile· Recruiting
- Bradford Hill Norte ( Site 1405)Verified postcodeAntofagasta, Chile· Recruiting
- The Second Affiliated Hospital of Anhui Medical University ( Site 9511)Verified postcodeHefei, China· Recruiting
- Beijing Cancer Hospital ( Site 9500)Verified postcodeBeijing, China· Recruiting
- The First Affiliated Hospital of Xiamen University ( Site 9503)Verified postcodeXiamen, China· Recruiting
Common questions
What is oesophageal squamous cell carcinoma?
It's a type of cancer that starts in the cells lining your oesophagus, the tube connecting your throat to your stomach.
What is immunotherapy and how does pembrolizumab work?
Immunotherapy helps your body's own immune system find and fight cancer cells. Pembrolizumab specifically helps your immune cells recognise and attack the cancer.
What is an 'investigational agent'?
This is a new medicine that is still being studied and is not yet approved as a standard treatment for your condition.
Will I definitely receive the new experimental drugs?
Yes, all participants will receive pembrolizumab, combined with one or more investigational agents, possibly with chemotherapy.
What happens if the treatment doesn't work for me?
The study team will monitor your progress closely. If the treatment isn't working or if you experience severe side effects, they will discuss other treatment options with you, according to your best medical interest.
How to find out more
Toll Free Number
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.