A Phase II, Multi-Center, Master Protocol to Evaluate the Efficacy and Safety of Volrustomig as Monotherapy or in Combination with Anti-cancer Agents in Participants with Advanced/Metastatic Solid Tumors (eVOLVE-02)
This research study, called eVOLVE-02, is testing a new drug named volrustomig. It's for patients with advanced or spreading solid cancers, specifically focusing on two types: a stomach cancer (esophageal squamous cell carcinoma) and a lung lining cancer (unresectable pleural mesothelioma). The study aims to find out if volrustomig can shrink tumors or stop them from growing, and whether it's safe to use. For some patients, volrustomig will be given on its own, while for others, it will be combined with standard chemotherapy. This is a Phase II study, meaning it's an earlier stage of research into new treatments.
At a glance
What is this study about?
This research study, called eVOLVE-02, is exploring a new treatment option for people living with certain types of advanced cancer. The main goal is to understand how effective a drug called volrustomig is, and to see if it causes any side effects. Advanced cancer means the cancer has grown or spread beyond its original location. This study specifically welcomes people with either unresectable pleural mesothelioma (a cancer in the lining of the lung that can't be removed by surgery) or esophageal squamous cell carcinoma (a type of cancer in the food pipe).
If you join the study, you might receive volrustomig on its own, or in combination with other well-known cancer medications like chemotherapy drugs (paclitaxel, cisplatin, fluorouracil). The researchers will carefully monitor how the treatment affects your cancer, for example, if tumors shrink or stop growing. They will also keep a close eye on your general health and any potential side effects.
This is a Phase II study, which means it’s an earlier step in testing new treatments. It's designed to see if the treatment shows enough promise to be studied in a larger group of people later on. The study is expected to last for an average of four years, during which time your health and the progress of your cancer will be regularly checked.
Key takeaways
- Tests a new drug, volrustomig, for advanced cancers.
- Specifically for pleural mesothelioma or esophageal squamous cell carcinoma.
- Aims to check safety and effectiveness (shrinkage or control of cancer).
- Participation includes regular clinic visits and monitoring.
- The study could last around four years.
- You can stop participating at any time.
Who may be eligible?
To be considered for this study, you must be at least 18 years old. The study is open to both men and women.
Beyond age and sex, there will be other specific health requirements that your doctor will discuss with you. These usually involve the type and stage of your cancer, your general health, and whether you've tried certain treatments before.
It's very important to talk with your doctor or the study team to see if this particular study is a good fit for you. They will review all your medical information to ensure your safety and that you meet all the necessary criteria.
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.
- Are you 18 years old or older?
- Do you have advanced unresectable pleural mesothelioma or esophageal squamous cell carcinoma?
- Are you able to attend regular clinic appointments?
- Are you willing to follow the study's treatment and monitoring plan?
What does participation involve?
If you decide to take part in this study, you would receive the study medication, volrustomig, possibly alongside other common cancer drugs like paclitaxel, cisplatin, or fluorouracil. You would have regular visits to the clinic for assessments. These assessments would likely include physical exams, blood tests, urine tests, and heart checks (like an ECG) to monitor your health and how the treatment is working. We would also take measurements of any visible or measurable cancers to see if they are getting smaller or staying the same.
The study is designed to run for an average of four years, during which time you would be closely monitored. You would have a team of doctors and nurses supporting you throughout the process.
Potential risks and benefits
Locations (2)
- —UnverifiedItaly
- —UnverifiedGermany
Common questions
What is 'volrustomig'?
Volrustomig is the name of the new drug being tested in this research study for certain advanced cancers.
What does 'Phase II' mean?
Phase II is an early stage of research where doctors want to see if a new treatment works and is safe in a small number of people before testing it more widely.
What cancers is this study for?
This study is specifically looking for people with advanced unresectable pleural mesothelioma (a lung lining cancer) or esophageal squamous cell carcinoma (a food pipe cancer).
How long will the study last?
The study is expected to run for an average of four years, during which time participants will be regularly monitored.
Can I stop participating if I want to?
Yes, you are free to leave the study at any time, for any reason, without it affecting your future medical care.
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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