An Open-Label, Multicenter Follow-up Study to Collect Long-term Data on Participants from Multiple Avelumab (MSB0010718C) Clinical Studies
This study looks at the long-term health and wellbeing of adults with solid cancers who have already taken part in an earlier clinical trial using a medicine called avelumab (also known as Bavencio). Avelumab is a type of immunotherapy. It works by helping your body's immune system recognise and attack cancer cells. While earlier studies showed how avelumab works in the short term, doctors need to understand its effects over many years. Researchers will monitor participants to see how long the treatment keeps cancer under control and whether any new side effects appear over time. By collecting this information, doctors can gain a clearer understanding of the drug's safety and long-term benefits. This helps improve future cancer care for patients across the UK and worldwide.
At a glance
What is this study about?
Solid tumours are cancers that form firm lumps in organs such as the bladder, kidneys, lungs, or skin. Avelumab (brand name Bavencio) is an immunotherapy drug given through a drip into a vein. Instead of attacking cancer cells directly like chemotherapy, it supports your own immune system so it can fight the cancer more effectively.
Most clinical trials follow patients for a limited amount of time. However, understanding how a cancer treatment works over several years is just as important. This 'follow-up' study gathers long-term information from people who were already treated with avelumab in previous trials. It aims to see how long the treatment benefits last and whether any unusual or late side effects emerge.
This research matters because it helps doctors and healthcare services, such as the NHS, understand the true long-term value of immunotherapy. The findings will provide clearer guidance on who benefits most from avelumab and how best to care for people after their treatment finishes.
Key takeaways
- This study tracks the long-term safety and benefits of the immunotherapy drug avelumab (Bavencio).
- It is only open to adults who took part in an earlier avelumab clinical trial for solid tumours.
- Doctors will monitor your health, scan results, and any side effects over several years.
- Taking part helps doctors understand how well immunotherapy works in the long run.
- Participation is entirely voluntary, and you can withdraw at any time.
Who may be eligible?
This study is open to adults aged 18 and over who have already taken part in a previous clinical trial testing avelumab for a solid tumour. Both men and women can join.
Because this is a continuation study, you cannot join if you were not already enrolled in one of the earlier avelumab trials. Your cancer care team will check your medical records to confirm whether your original trial qualifies.
You will also need to be able to attend follow-up hospital visits or telephone check-ins so the study team can monitor your health safely.
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.
- I am aged 18 or older.
- I have been diagnosed with a solid tumour (cancer).
- I was enrolled in an earlier clinical trial that used avelumab (Bavencio).
- I am willing to attend regular hospital check-ups and have health scans.
What does participation involve?
If you take part, your care will be very similar to your previous trial routine. You will visit the hospital clinic for regular check-ups. These visits usually involve physical examinations, routine blood tests, and scans (such as CT or MRI scans) to see how your tumour is responding. If you are still receiving avelumab, it will be given as a drip into your vein every few weeks. If you have finished treatment, visits may simply involve monitoring your health and answering questions about how you feel. The study will continue to follow your health over several years, but you can discuss the exact schedule with your hospital team.
Potential risks and benefits
Locations (7)
- —UnverifiedItaly
- —UnverifiedBulgaria
- —UnverifiedPoland
- —UnverifiedRomania
- —UnverifiedFrance
- —UnverifiedSpain
- —UnverifiedHungary
Common questions
What is avelumab?
Avelumab (Bavencio) is an immunotherapy medicine that helps your body's natural defences recognise and fight cancer cells.
Why is this called an 'open-label' study?
Open-label means that both you and your doctor know exactly which medicine you are receiving. There is no dummy treatment (placebo).
Can I join if I have never taken avelumab before?
No. This study is specifically for people who were already enrolled in an earlier trial testing avelumab.
Will taking part cost me anything?
No. The study drug and study-related tests are provided free of charge, and you may be able to claim back travel expenses.
Can I leave the study if I change my mind?
Yes. You can leave the study at any time, for any reason. Your normal medical care will continue as usual.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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