All studies
Active not recruitingPHASE2INTERVENTIONAL

Nivolumab in Patients With Type B3 Thymoma and Thymic Carcinoma (NIVOTHYM)

This study, called NIVOTHYM, is investigating a drug called nivolumab for patients with specific types of thymus gland cancer, known as Type B3 Thymoma or Thymic Carcinoma. These are cancers that have either returned or spread and cannot be fully removed by surgery. Participants in this study have already received a platinum-based chemotherapy treatment for their advanced cancer. The main goal is to see how well nivolumab works and to understand its side effects in this group of patients. By gathering this information, researchers hope to find more effective ways to treat these rare cancers.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Enrolment target
55
Start
11 Apr 2018
Estimated completion
01 Dec 2027

What is this study about?

The NIVOTHYM study is a research project designed to learn more about a particular medicine called nivolumab. This medicine is being tested for people who have specific types of cancer that start in the thymus gland. These are called Type B3 Thymoma and Thymic Carcinoma. The thymus is a small gland located behind your breastbone that plays a role in your immune system.

This study is focusing on patients whose cancer has either come back or spread after already receiving a standard first treatment with chemotherapy that included a 'platinum-based' drug. For these patients, surgery or other radical treatments are no longer an option to cure the cancer. The researchers want to see if nivolumab can help shrink these cancers or slow their growth, and also understand any side effects it might cause.

Finding new and effective treatments for rare cancers like thymoma and thymic carcinoma is very important. Studies like NIVOTHYM help doctors understand how new medications work, and whether they can offer a new option for patients when standard treatments are no longer effective. The information gathered from this study will contribute to improving future care for people with these conditions.

Key takeaways

  • The study tests nivolumab for specific advanced thymus cancers.
  • It's for people who've already had platinum-based chemotherapy.
  • The main goals are to check how well nivolumab works and its side effects.
  • Findings could offer a new treatment option for these rare cancers.
  • Your health will be closely monitored throughout your participation.

Who may be eligible?

To be considered for this study, you would need to have either Type B3 Thymoma or Thymic Carcinoma that has returned or spread, and can't be treated with surgery or other radical methods meant to cure it. You must have already had at least one round of chemotherapy for your advanced cancer, using a 'platinum-based' drug. Even if you had platinum-based chemotherapy before surgery or radiotherapy, you might still be eligible if it was less than six months ago and your cancer has progressed.

Your cancer must show signs of getting worse (progressing) during or after your previous chemotherapy, and doctors must be able to measure it on scans. You also need to be at least 18 years old and generally well enough to take part. This means your body needs to be able to handle the treatment, so doctors will check your blood tests to make sure your liver, kidneys, and blood cells are working well enough.

The research team will also need a sample of your tumour tissue, either from a past biopsy or surgery, to check for certain markers. This helps them understand more about your cancer and how the treatment might work, but your eligibility won't depend on the results of this test.

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 Type B3 Thymoma or Thymic Carcinoma?
  2. Has your cancer come back or spread and can't be cured by surgery?
  3. Have you already had at least one platinum-based chemotherapy for your advanced cancer?
  4. Are you 18 years old or older?
  5. Are your general health (blood, liver, kidney function) good enough according to your doctor?
Answer every question to see your result.

What does participation involve?

If you join the NIVOTHYM study, you will receive the study drug, nivolumab. You will have regular appointments for check-ups, blood tests, and scans (like CT or MRI scans of your chest and tummy) to see how you are responding to the treatment and to monitor your health. Sometimes, brain scans might also be needed. The length of time you will be on the treatment can vary, but generally, participants continue the treatment as long as it is benefiting them and they are not experiencing severe side effects. After stopping the treatment, there will likely be a follow-up period to continue monitoring your health and any long-term effects.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing a new treatment that might help when other options haven't worked. However, like all medicines, nivolumab can cause side effects, and some may be serious. The research team will carefully monitor you for any side effects and provide support. It's important to remember that there's no guarantee the treatment will work for everyone, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (20)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Institut Jules Bordet
    Verified postcode
    Brussels, Belgium
  • Universitair Ziekenhuis Antwerpen (UZA)
    Verified postcode
    Edegem, Belgium
  • CHU de Brest
    Verified postcode
    Brest, France
  • CHU de Lyon - Hopital Louis Pradel
    Verified postcode
    Bron, France
  • Centre Francois Baclesse
    Verified postcode
    Caen, France
  • CHU de Grenoble - La Tronche - Hôpital A. Michallon
    Verified postcode
    La Tronche, France
  • Assistance Publique - Hopitaux de Marseille - Hopital Nord (APHM)
    Verified postcode
    Marseille, France
  • Institut Curie- Hopital de Paris
    Verified postcode
    Paris, France
  • CHU Toulouse - Hopital Larrey
    Verified postcode
    Toulouse, France
  • Gustave Roussy
    Verified postcode
    Villejuif, France
  • The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
    Verified postcode
    Amsterdam, Netherlands
  • Academisch Ziekenhuis Maastricht
    Verified postcode
    Maastricht, Netherlands

Common questions

What is the thymus gland?

The thymus is a small gland in your chest, behind your breastbone, that is part of your immune system and important for developing certain white blood cells.

What is nivolumab?

Nivolumab is a type of immunotherapy medicine. It works by helping your body's own immune system to recognise and fight cancer cells.

What does 'platinum-based chemotherapy' mean?

This refers to a group of chemotherapy drugs that contain platinum. These drugs are commonly used to treat various types of cancer.

Will I get paid to be in the study?

Clinical trials generally do not pay participants for their time, but any travel expenses or other specific costs might be covered. You should ask the study team about this.

How can I find out if this study is right for me?

The best way to find out is to talk to your doctor or cancer specialist. They can review your medical history and determine if you meet the study's requirements.

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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