Study of Volrustomig as Monotherapy or in Combination With Anti- Cancer Agents in Participants With Advanced/Metastatic Solid Tumors
This research study, called eVOLVE-02, is exploring a new drug, Volrustomig, for people with advanced or metastatic solid cancers. This means cancers that have spread or are difficult to treat. The study is divided into different groups, called sub-studies, focusing on specific cancers such as cervical cancer, head and neck cancer, oesophageal cancer, and a type of lung cancer called pleural mesothelioma. In some cases, Volrustomig will be given on its own, and in others, it will be combined with standard chemotherapy drugs like Cisplatin or Paclitaxel. The main goals are to find out how effective Volrustomig is in treating these cancers and to check for any side effects, ensuring it is safe for patients.
At a glance
What is this study about?
This study, known as eVOLVE-02, is looking into a new treatment called Volrustomig for several advanced cancers. When cancer is described as 'advanced' or 'metastatic', it means it has spread from where it started to other parts of the body, making it harder to treat. Researchers want to understand if Volrustomig can help people with these types of cancers and if it's safe to use.
The study is divided into five different groups, each focusing on a specific cancer. For example, some groups will be for people with cervical cancer, others for head and neck cancer, oesophageal cancer, or a rare lung cancer called unresectable pleural mesothelioma. In some of these groups, Volrustomig will be given by itself, while in others, it will be combined with standard chemotherapy medicines that are already used to treat cancer. This helps researchers see if Volrustomig works better when given alone or alongside existing treatments.
The main purpose is to see how much the treatment can shrink or control the cancer and to monitor any side effects people might experience. Finding new, effective, and safe treatments is very important for improving the lives of people with advanced cancers.
Key takeaways
- The study explores a new drug (Volrustomig) for advanced cancers.
- It aims to find out if Volrustomig is effective and safe.
- It's being tested alone, or with standard chemotherapy.
- Specific cancers include cervical, head/neck, oesophageal, and mesothelioma.
- Close monitoring for effects and side effects will be part of the study.
Who may be eligible?
To join this study, you need to be at least 18 years old. You must also be generally well enough to take part, meaning you can look after yourself for most of the day and have good basic organ function. Your cancer needs to be measurable, which means doctors can clearly see and track its size. You should also expect to live for at least 12 weeks.
There are certain reasons why you might not be able to join. For example, if your cancer has spread to your brain in a way that is causing symptoms or needs medication, you might not be eligible for most groups. Also, certain types of cancer or previous medical conditions, like some uncontrolled infections or other serious illnesses, might prevent you from taking part. If you’ve recently had radiotherapy or have allergies to certain chemotherapy drugs used in the study, you might also be excluded from specific groups.
The research team will carefully review your medical history and current health to determine if this study is suitable for you. They will explain everything in detail and answer any questions you have.
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 cervical, head and neck, oesophageal, or pleural mesothelioma cancer?
- Are you generally well and able to carry out most daily activities?
- Can your cancer be measured by scans?
- Do you not have severe, uncontrolled brain metastases or other serious conditions?
What does participation involve?
If you decide to take part in this study, you will receive the new medicine, Volrustomig. Depending on which group you are in, you might receive Volrustomig on its own or together with standard chemotherapy drugs like Cisplatin, Carboplatin, Paclitaxel, or 5-FU. You will have regular appointments for check-ups, which will include blood tests and scans, to monitor the cancer's response and to look for any side effects. You will need to provide a small sample of your tumour tissue. The exact schedule of visits and treatments will vary depending on your specific study group, but you can expect ongoing monitoring for the duration of your participation in the study. The total duration of your involvement will be explained to you by the study team.
Potential risks and benefits
Locations (95)
- Research SiteVerified postcodeLos Angeles, United States· Withdrawn
- Research SiteVerified postcodeBaltimore, United States· Not yet recruiting
- Research SiteVerified postcodeNew York, United States· Not yet recruiting
- Research SiteVerified postcodeStony Brook, United States· Not yet recruiting
- Research SiteVerified postcodeColumbus, United States· Not yet recruiting
- Research SiteVerified postcodePhiladelphia, United States· Not yet recruiting
- Research SiteVerified postcodeClayton, Australia· Recruiting
- Research SiteVerified postcodeNedlands, Australia· Not yet recruiting
- Research SiteVerified postcodeIjuí, Brazil· Recruiting
- Research SiteVerified postcodeLondrina, Brazil· Recruiting
- Research SiteVerified postcodePorto Alegre, Brazil· Not yet recruiting
- Research SiteVerified postcodeSanto André, Brazil· Not yet recruiting
Common questions
What is Volrustomig?
Volrustomig is a new medicine being investigated as a potential treatment for advanced cancers. We are exploring how well it works and its safety.
What types of cancer are being studied?
This study is looking at advanced cervical cancer, head and neck cancer, oesophageal cancer, and unresectable pleural mesothelioma.
Will I receive Volrustomig alone or with other drugs?
Depending on your specific cancer type and the study group, you might receive Volrustomig by itself or combined with standard chemotherapy medicines.
What is 'advanced/metastatic' cancer?
This means the cancer has grown or spread from its original site to other parts of the body, making it more challenging to treat.
Can I leave the study at any time?
Yes, you are free to withdraw from the study at any point, and this will not affect your ongoing medical care.
How to find out more
AstraZeneca Clinical Study Information Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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