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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.

  1. Are you 18 years old or older?
  2. Do you have advanced cervical, head and neck, oesophageal, or pleural mesothelioma cancer?
  3. Are you generally well and able to carry out most daily activities?
  4. Can your cancer be measured by scans?
  5. Do you not have severe, uncontrolled brain metastases or other serious conditions?
Answer every question to see your result.

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

Taking part in this study could offer a potential benefit by giving you access to a new treatment that might be more effective for your cancer, but this is not guaranteed as it's still being studied. Like all medicines, Volrustomig and the chemotherapy drugs used in this study can have side effects, which the study team will explain to you in detail. There might also be unknown risks, as this is a new treatment. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (95)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Research Site
    Verified postcode
    Los Angeles, United States· Withdrawn
  • Research Site
    Verified postcode
    Baltimore, United States· Not yet recruiting
  • Research Site
    Verified postcode
    New York, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Stony Brook, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Columbus, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Philadelphia, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Clayton, Australia· Recruiting
  • Research Site
    Verified postcode
    Nedlands, Australia· Not yet recruiting
  • Research Site
    Verified postcode
    Ijuí, Brazil· Recruiting
  • Research Site
    Verified postcode
    Londrina, Brazil· Recruiting
  • Research Site
    Verified postcode
    Porto Alegre, Brazil· Not yet recruiting
  • Research Site
    Verified postcode
    Santo 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?

Register your interest

Share your details and the research team for "Study of Volrustomig as Monotherapy or in Combination With A…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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