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Active not recruitingPHASE2INTERVENTIONAL

Cisplatin + Radiotherapy vs Durvalumab + Radiotherapy Followed by Durvalumab vs Durvalumab + Radiotherapy Followed by Tremelimumab + Durvalumab in Intermediate-Risk HPV-Positive Oropharyngeal SCC

This research is investigating new treatments for a type of throat cancer caused by the human papillomavirus (HPV). Normally, people with this cancer get radiation and chemotherapy (using a drug called cisplatin) at the same time, with no further treatment. This study wants to see if using a different type of drug, called durvalumab (an immunotherapy), alongside radiation initially, and then continuing with durvalumab afterwards, could be more effective. Immunotherapy helps your body's own immune system fight the cancer. The study also explored adding another immunotherapy drug called tremelimumab later on, which works in a slightly different way. The aim is to find out if these new approaches can better prevent the cancer from returning.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
Canadian Cancer Trials Group
Enrolment target
129
Start
28 May 2018
Estimated completion
31 Jul 2026

What is this study about?

This study is exploring different ways to treat a specific type of throat cancer called oropharyngeal squamous cell carcinoma. This cancer is linked to the Human Papillomavirus (HPV). When people have this particular cancer, the usual treatment involves a combination of radiation therapy and a chemotherapy drug called cisplatin, given together. After this, no further treatment is typically given. This trial wants to see if we can improve on this standard approach.

The main idea is to test a drug called durvalumab, which is an 'immunotherapy'. Immunotherapy drugs work by helping your body's natural defence system (your immune system) recognise and attack cancer cells. Instead of cisplatin, this study considers giving durvalumab alongside radiation initially. Then, participants might continue to receive durvalumab afterwards to reduce the chance of the cancer coming back. Durvalumab has been tested in a lot of people for different cancers and seems promising.

The trial also looked at another immunotherapy drug called tremelimumab. This drug works in a slightly different way to boost your immune system's fight against cancer, possibly making durvalumab even more effective. However, new people joining the study from February 2019 onward will no longer be offered tremelimumab. By comparing these different combinations, researchers hope to find treatments that are more effective at shrinking tumours and preventing the cancer from returning.

Key takeaways

  • This study compares standard treatment for HPV-positive throat cancer with new immunotherapy drugs.
  • It aims to find out if durvalumab, with or without tremelimumab, can improve outcomes.
  • Immunotherapy helps your own immune system fight cancer.
  • Participation involves regular hospital visits, treatments, and follow-up appointments.
  • You can stop participating at any time without affecting your normal care.

Who may be eligible?

To be considered for this study, you would need to have been diagnosed with a specific type of throat cancer (oropharyngeal squamous cell carcinoma) that is linked to the Human Papillomavirus (HPV). This cancer should be locally advanced but not have spread to other parts of your body. Doctors will check this using scans and biopsies.

You also need to be generally well enough to take part, meaning you can mostly look after yourself. The study is open to both men and women, and you must be at least 18 years old. If you're a woman who could get pregnant, or a man whose partner could get pregnant, you'll need to agree to use effective contraception during the study. You'll also need to provide some tissue samples (from your tumour), blood, saliva, and a throat swab for further tests. You should also be able to understand and complete questionnaires about your quality of life.

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.

  1. Do you have HPV-positive throat cancer (oropharyngeal squamous cell carcinoma)?
  2. Has your cancer not spread to other parts of your body?
  3. Are you generally well and able to look after yourself?
  4. Are you 18 years old or older?
  5. Are you willing to provide tissue, blood, and saliva samples?
  6. Are you able to attend regular hospital appointments?
Answer every question to see your result.

What does participation involve?

If you join this study, your journey will begin with a thorough check-up, including scans and assessments, to make sure you're suitable. Once you're officially in the study, you'll be assigned to one of the treatment groups – either the standard treatment (radiation plus cisplatin) or one of the groups receiving radiation plus durvalumab, potentially followed by more durvalumab. All initial treatments, including radiation and chemotherapy/immunotherapy, will be given for a specific period.

After the initial treatment, depending on your assigned group, you might continue to receive durvalumab (and previously, tremelimumab) as an 'additional' treatment to help prevent the cancer from returning. This would involve regular visits to the hospital for these infusions. You'll also have regular check-ups, scans, and blood tests throughout the treatment period and for a while afterwards, to monitor your health and how well the treatment is working. You will also be asked to fill out questionnaires about how you are feeling and your quality of life. The exact number of visits, tests, and total length of your involvement will depend on your specific treatment path, but follow-up is generally long-term to track your progress.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. You might benefit from receiving a new treatment that could be more effective than standard care, or you would receive the current standard treatment. The information gathered from your participation could also help others with similar conditions in the future. However, there are potential risks from the treatments; chemotherapy and immunotherapy drugs can have side effects, which your medical team will discuss with you in detail. There's also no guarantee that the new treatments will work better for you. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (26)

  • Cliniques Universitaires Saint-Luc
    Verified postcode
    Brussels, Belgium
  • University Hospital of Antwerp
    Verified postcode
    Edegem, Belgium
  • University Hospital of Gent
    Verified postcode
    Ghent, Belgium
  • University Hospital Leuven
    Verified postcode
    Leuven, Belgium
  • Clinique St. Elizabeth
    Verified postcode
    Namur, Belgium
  • AZ Sint Augustinus
    Verified postcode
    Wilrijk, Belgium
  • Cross Cancer Institute
    Verified postcode
    Edmonton, Canada
  • CancerCare Manitoba
    Verified postcode
    Winnipeg, Canada
  • QEII Health Sciences Centre
    Verified postcode
    Halifax, Canada
  • Health Sciences North
    Verified postcode
    Greater Sudbury, Canada
  • Juravinski Cancer Centre at Hamilton Health Sciences
    Verified postcode
    Hamilton, Canada
  • Kingston Health Sciences Centre
    Verified postcode
    Kingston, Canada

Common questions

What is HPV-positive oropharyngeal SCC?

It's a type of throat cancer (specifically affecting the back of the throat, tonsils, and base of the tongue) that is caused by the Human Papillomavirus (HPV).

What are durvalumab and tremelimumab?

They are types of immunotherapy drugs. They work by boosting your body's immune system to help it fight cancer cells more effectively.

Why are new treatments being tested if there's already a standard one?

Researchers are always looking for better, more effective treatments that might have fewer side effects or work better at stopping cancer from coming back.

Will I know which treatment I'm getting?

In some studies, participants may or may not know which treatment they are receiving. The study team will explain how this works before you agree to join.

Is tremelimumab still part of the study?

No, as of February 2019, tremelimumab is no longer given to new patients joining this study.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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