Q1: Can I be sure that I will receive the experimental treatment?

When we do not know which way of treating patients is best, we need to compare these treatments. Everyone who agrees to take part in this study will be put into a treatment group.

The treatment you receive will be chosen by a process called randomisation, the treatment is randomly allocated by computer. This means that you have an equal chance of being treated with one of the below treatments. You and your Research Physician will know which treatment you are receiving.

You will receive one of the following treatments:

– Control group: standard treatment also known as Standard of Care;

– Experimental group: experimental treatment in which the study medication L19-IL2 will be given.

Q2: Are there any possible disadvantages or risks from taking part?

It is not clear whether you will benefit from participating in this study.

If you are in the group that receives the standard treatment, the side effects are the same as if you would not participate in the study.

If you are in the experimental group that receives the new treatment, the possible disadvantages of participating are the possible side effects of the study medication L19-IL2.

For both groups (control and experimental treatment), the possible disadvantages are:

• not being allowed to become pregnant
• the time spent on the trial
• the inconvenience of additional tests and investigations.

As the experimental treatment is new, the effect is uncertain. It is therefore possible that you experience side effects but that you do not benefit from the proposed experimental treatment.

Q3: Is the chance to have a good response increased?

The possible benefit is that the combination of radiotherapy with immunotherapy can keep the disease under control for a longer period of time and that just maybe it could disappear completely. We suggest you read the interview of the patient on the website under Patient Access.

The information we get from this study may help us to treat other patients with cancer more effectively in the future.

 

Q4: Will I have to come to the hospital more often?

Only if you receive the study medication (L19-IL2). You will receive infusion treatment with the study medication L19-IL2 on day 1, 3 and 5 of every three-week cycle. Maximum six courses/cycles. The other visits will be the same as for non-participating patients.

 

Q5: Has this new treatment been tested on animals?

Yes, after multiple tests in the lab it was eventually tested in mice (see the papers: doi: 10.1080/2162402X.2017.1414119). All experiments were performed in accordance with local institutional guidelines for animal welfare and were approved by the Animal Ethical Committee of the University of Maastricht (Maastricht, the Netherlands).

 

Q6: Has this new treatment been tested on patients?

Yes, we have already tested L19-IL2 in a phase 1 safety trial. The medication dose, that is also used in this trial, resulted in promising tumour effects and common and mild side effects. We advise you to read the interview of the patient treated with L19-IL2 on the website in the Patient Access Section.

Q7: Will it cost me money?

No, you won’t have to pay anything related to this trial.

Q8: Does this trial have an Insurance?

Yes. In the unlikely event that you become ill or are injured as a result of taking part in this study you will be covered by insurance held by Maastricht University. Compensation will be provided for any injury caused by taking part in this study in accordance with the guidelines of the Association of the British Pharmaceutical Industry (ABPI).

We will pay compensation when the injury may have resulted from :

• A drug being tested or administered as part of the trial protocol; or
• Any test or procedure you received as part of the trial.

In the event that something does go wrong and you are harmed during the research and this is due to someone’s negligence, then you may have grounds for a legal action for compensation against your hospital but you may have to pay your own legal costs. If you wish to make a claim against this insurance you should talk to your

study doctor.

 

Q9: How often will I receive the study medication (L19-IL2)?

If you receive the study medication (L19-IL2), you will receive infusion treatment with the study medication L19-IL2 on day 1, 3 and 5 of every three-week cycle. Maximum six courses/cycles. The other visits will be the same as for the non-participating patients.

 

Q10: Will I have to receive radiotherapy over several weeks?

It depends on the locations of the irradiated lesion. Generally, radiotherapy only takes 1 or 2 weeks in one or three sessions.

Q11: Is the study medication (L19-IL2) a form of immunotherapy?

Yes, the study medication is a form of immunotherapy. Also called immunocytokine therapy because the “IL2” is a cytokine that has an important activating role in your immune system.

Q12. Why should I participate in this study?

There are at least 4 reasons

1. Clinical trials are necessary Clinical trials are a required step in bringing new breakthroughs from the bench to the bedside—from the researcher to the patient
2. Clinical trials help future patients Participation is critical in helping prevent, diagnose and cure diseases and illnesses. When you participate in a clinical trial, you are contributing to research that could bring new treatments one step closer to reaching patients across the nation.
3. Clinical trials give you access to new treatments Participating in a clinical trial may give you access to experimental, cutting-edge treatment options.
4.  Clinical trials give you access to a medical team that carefully monitors your disease and your overall health. It is fair to say, the monitoring will be more thorough than if you are not included in a clinical trial.

 

Q13; Are there other websites for patient participation in clinical trials?

Yes, see for example

• https://www.nih.gov/health-information/nih-clinical-research-trials-you/why-should-i-participate-clinical-trial
• https://thedoctorweighsin.com/participate-in-clinical-trials/
• https://www.psychologytoday.com/us/blog/when-your-adult-child-breaks-your-heart/201503/should-i-participate-in-clinical-trial
• https://www.agingresearch.org/five-reasons-you-should-participate-in-clinical-trials/#:~:text=2.,reaching%20patients%20across%20the%20nation.