Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Durvalumab
This study, called ROSY-D, is designed for cancer patients who have been taking the drug durvalumab in a previous clinical trial and have been getting good results. If your doctor believes the treatment is still helping you, this study allows you to continue receiving durvalumab. The main goal is to keep providing this treatment to patients who are benefiting from it after their original trial has ended or reached its maximum time. You would continue treatment indefinitely, as long as it's still benefiting you and you don't develop any serious side effects or your cancer gets worse. It's for adults aged 18 to 99.
At a glance
What is this study about?
Imagine you're taking a medicine in a research study, and it's really helping you. What happens when that study ends? The ROSY-D study is designed for cancer patients in exactly that situation. If you've been part of another study using a medicine called durvalumab, and your doctor thinks it's still working well for you, this new study allows you to keep getting that treatment. It's like a 'roll-over' to make sure you can continue benefiting from a helpful medicine.
The main idea behind ROSY-D is simple: if a treatment is working and improving your health or stopping your cancer from growing, then you should be able to continue receiving it even after the original study finishes. This study is for those patients who have completed their first trial but are still doing well on durvalumab.
You would continue to receive the durvalumab treatment for an extended period, as long as your doctor believes it is still benefiting you. The study will only stop if your health changes significantly, you experience severe side effects, your cancer starts to get worse, or your doctor decides it's no longer the best option for you.
Key takeaways
- This study is for cancer patients already benefiting from durvalumab in another trial.
- It allows you to continue receiving durvalumab after your previous study ended.
- Your doctor must confirm the treatment is still helping you.
- You would receive treatment every 4 weeks and have regular health checks.
- Participation continues as long as the treatment is beneficial and safe.
- You can stop participating at any time.
Who may be eligible?
To be able to join this study, you must have already been enrolled in another AstraZeneca study using durvalumab and have reached the end of that study. Most importantly, your doctor must believe that the durvalumab treatment is still benefiting you.
There are also some reasons why you might not be able to join. For example, if you had very serious side effects (like Grade 3 or higher) from the durvalumab that hadn't cleared up when your previous study ended, you wouldn't be able to join. You also can't be in another medical research study at the same time if it's not compatible with this one. If your cancer got worse or you had to stop your previous study permanently because of side effects, this study wouldn't be for you.
Additionally, you can't join if you have certain active infections like COVID-19, tuberculosis, hepatitis B or C, or HIV. The study is open to anyone aged 18 to 99.
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.
- Have I already been in an AstraZeneca study with durvalumab?
- Does my doctor think durvalumab is still helping me?
- Do I have any serious side effects from my last treatment that haven't gone away?
- Do I have an active infection like COVID-19 or hepatitis B/C?
- Am I at least 18 years old?
What does participation involve?
If you join the ROSY-D study, you will continue to receive the durvalumab treatment you were getting in your previous study. This will be given as a fixed dose of 1500 mg every 4 weeks. You'll have regular visits to the clinic so the medical team can monitor your health and make sure the treatment is still working well and not causing any serious side effects.
Throughout your time in the study, doctors and nurses will closely watch how you're doing. They'll check for any changes in your health, carry out tests, and discuss any concerns you might have. You'll continue in the study for as long as the treatment is helping you and you don't experience any issues that would require you to stop, such as your cancer getting worse or developing severe side effects. The total duration of your participation is indefinite, meaning it continues as long as it's beneficial.
Potential risks and benefits
Locations (123)
- Research SiteVerified postcodeNewport Beach, United States
- Research SiteVerified postcodeDenver, United States
- Research SiteVerified postcodeMemphis, United States
- Research SiteVerified postcodeRosario, Argentina
- Research SiteVerified postcodeBox Hill, Australia
- Research SiteVerified postcodeMelbourne, Australia
- Research SiteVerified postcodeCharleroi, Belgium
- Research SiteVerified postcodeBarretos, Brazil
- Research SiteVerified postcodeSão José do Rio Preto, Brazil
- Research SiteVerified postcodeSofia, Bulgaria
- Research SiteVerified postcodeSofia, Bulgaria
- Research SiteVerified postcodeKingston, Canada
Common questions
What is durvalumab?
Durvalumab is a type of cancer medicine, often called immunotherapy, that helps your own immune system fight cancer cells.
Why is this study called 'Roll Over'?
It's called 'Roll Over' because it allows patients to seamlessly move from one study to continue receiving treatment in this new study without interruption.
How often will I receive the treatment?
You will receive the durvalumab treatment as an infusion every 4 weeks.
What happens if the treatment stops working?
If the treatment is no longer helping your cancer, or if you develop serious side effects, you would stop receiving treatment in this study.
Can I stop participating in the study at any time?
Yes, you are free to leave the study at any time, for any reason, and it won't affect your future medical care.
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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