European Larynx Organ Preservation Study (ELOS) [MK-3475-C44]
The ELOS study is for people with advanced throat cancer (larynx or hypopharynx) that could usually require surgery to remove the voice box. This study tests whether adding a drug called Pembrolizumab (Keytruda®) to standard chemotherapy and radiotherapy treatment can help more patients keep their voice box and live longer. Participants will receive initial chemotherapy. Depending on how the tumour responds, some will continue with chemotherapy and radiotherapy, and others might need surgery. Those in the new treatment group will also receive Pembrolizumab for about a year. The main goal is to find out if this new approach can improve the chances of avoiding surgery while still effectively treating the cancer.
At a glance
What is this study about?
The European Larynx Organ Preservation Study (ELOS) is looking into new ways to treat advanced throat cancer, specifically in the larynx (voice box) or hypopharynx (area behind the voice box). This type of cancer, if advanced, often requires surgery to remove the voice box, which can significantly change a person's life. The study aims to see if we can save the voice box for more patients while still giving them the best possible treatment.
Currently, many patients with this type of cancer receive chemotherapy followed by radiotherapy. This study compares this standard approach with an additional treatment: a drug called Pembrolizumab, also known as Keytruda®. This drug is designed to help your own immune system fight the cancer. The researchers want to know if adding Pembrolizumab can lead to better outcomes for patients, particularly helping them avoid surgery to remove the larynx.
Participation in this study is important because it could lead to new and more effective ways to treat throat cancer, potentially reducing the need for major surgery and improving the quality of life for many patients. The study is a "Phase II" trial, which means it's one of the earlier steps in testing a new treatment, focusing on how well it works and if it's safe. Findings from this study will help doctors understand if this combination therapy should be tested further in larger studies.
Key takeaways
- Tests a new approach for advanced throat cancer.
- Aims to help patients keep their voice box (larynx).
- Compares standard treatment with an added immune-boosting drug (Pembrolizumab).
- Treatment involves chemotherapy, radiotherapy, and potentially Pembrolizumab.
- Participation could lead to improved cancer treatments.
- Your decision to join is entirely voluntary.
Who may be eligible?
This study might be for you if you are at least 18 years old and have been diagnosed with advanced throat cancer affecting your larynx (voice box) or hypopharynx (the lower part of the throat). Your medical team must believe that your type of cancer would typically require surgery to remove your voice box, but they can still remove all of your cancer completely if needed. Importantly, your cancer cells need to show a specific marker called "PD-L1 expression" when tested.
There are also some general health requirements, such as having good overall health, as measured by your ability to do daily activities (known as ECOG performance status 0-1), and your organs (like your liver and kidneys) must be working well. If you are a woman who could become pregnant, or a man whose partner could become pregnant, you would need to agree to use effective contraception during the study and for a period afterwards.
You would not be able to join if you are pregnant or breastfeeding, have certain other serious health conditions that could interfere with the study treatments, or if your cancer has already spread to other parts of your body in a way that makes it unsuitable for this treatment approach. The study doctors will go through all the details with you carefully to see if you meet all the criteria.
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 at least 18 years old?
- Do you have advanced cancer of the larynx or hypopharynx?
- Does your cancer have a specific marker called PD-L1?
- Are you generally in good health and able to manage daily activities?
- Are you able to use contraception if necessary?
What does participation involve?
If you decide to take part, you'll first have some initial chemotherapy. After the first cycle, doctors will check how your tumour has responded. Depending on this, you'll either continue with more chemotherapy cycles followed by radiotherapy, or you might need surgery to remove your voice box, followed by further radiation. If you are in the group receiving the new drug, Pembrolizumab, you would get this intravenously (into a vein) every three weeks for about 12 months, regardless of whether you had surgery or not. Throughout the study, you'll have regular hospital visits for check-ups, scans, and to assess your general health and how well you're swallowing. The total duration of active treatment and follow-up will vary depending on your treatment path, but the Pembrolizumab part of the treatment lasts for a year.
Potential risks and benefits
Locations (9)
- Universitätsklinikum Mannheim, Klinik für Hals-Nasen-Ohrenheilkunde Theodor-Kutzer-Ufer 1-3Verified postcodeMannheim, Germany· Recruiting
- Universitätsklinikum Ulm / Ulm University Medical Center, Klinik für Hals- Nasen-Ohrenheilkunde und Kopf-Halschirurgie, Frauensteige 12Verified postcodeUlm, Germany· Recruiting
- Klinikum rechts der Isar der TU München, Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde, Ismaninger Straße 22Verified postcodeMünchen, Germany· Not yet recruiting
- Universität Regensburg, Klinik und Poliklinik für Strahlentherapie Franz-Josef-Strauss-Allee 11Verified postcodeRegensburg, Germany· Recruiting
- Universitätsklinikum Würzburg, Klinik für Hals-, Nasen-, Ohrenheilkunde, Josef-Schneider-Straße 8Verified postcodeWürzburg, Germany· Recruiting
- Klinikum Ernst von Bergmann, Klinik für Hämatologie, Onkologie und Palliativmedizin, Charlottenstr. 72Verified postcodePotsdam, Germany· Not yet recruiting
- Universitätsklinikum Köln, Klinik für Hals-, Nasen-, Ohrenheilkunde, Kerpener Str. 62Verified postcodeCologne, Germany· Not yet recruiting
- University of Leipzig, Department für Kopf- und Zahnmedizin, Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde, Liebigstrasse 12Verified postcodeLeipzig, Germany· Recruiting
- Universitätsklinikum Jena Klinik für Hals-, Nasen- und Ohrenheilkunde, Am Klinikum 1Verified postcodeJena, Germany· Not yet recruiting
Common questions
What is Pembrolizumab (Keytruda®)?
It's a drug that helps your body's immune system recognise and fight cancer cells more effectively.
Will I definitely avoid surgery if I join this study?
Not necessarily. The goal is to try and help you keep your voice box, but some patients in the study may still need surgery, depending on how their cancer responds to initial treatment.
How long will the drug treatment last?
If you receive Pembrolizumab, it will be given every three weeks for about 12 months.
What kind of cancer is this study for?
This study is for advanced cancer in the voice box (larynx) or the area just behind it (hypopharynx).
Is this a new type of study?
It's a Phase II study, which means it's an early stage of testing this new treatment combination to see how well it works and if it's safe.
How to find out more
Andreas Dietz, MD PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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