Ongoing, recruitingPhase I and Phase II (Integrated)- Bioequivalence StudyInterventional

MOVIE_A phase I/II basket trial evaluating a combination of Metronomic Oral Vinorelbine plus anti-PD-L1/anti-CTLA4 ImmunothErapy in patients with advanced solid tumours.

This research study, called MOVIE, is investigating a new way to treat advanced cancers that have spread or are difficult to treat. The study combines a common chemotherapy drug, vinorelbine, given in small, regular doses by mouth, with two types of immunotherapy drugs, durvalumab and tremelimumab, given by infusion. Immunotherapy works by helping your body's own immune system fight cancer. The first part of the study (Phase 1) is all about finding the highest safest dose of vinorelbine when used with the fixed doses of the immunotherapy drugs. The second part (Phase 2) will then look at how well this combination treatment shrinks tumours or stops them from growing for at least 24 weeks. Researchers will also be checking for any side effects throughout the study. This study is for adults aged 18 and over with advanced solid tumours.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Bioequivalence Study

Sponsor

Unicancer

Enrolment target

126

Start

29 Oct 2024

Patients with locally advanced or metastatic solid tumours

What is this study about?

This study, called MOVIE, is an important step in trying to find better ways to treat advanced solid tumours. "Advanced" means cancers that have either spread to other parts of the body (metastatic) or are in a very advanced stage locally, making them harder to treat with standard methods.

The research combines two different approaches. The first is a chemotherapy drug called vinorelbine, but it's given in a special way – in small, regular doses by mouth, known as 'metronomic' therapy. This method aims to keep a steady low level of the drug in the body, which might reduce side effects compared to traditional higher doses, while still being effective. The second part of the treatment involves two immunotherapy drugs, durvalumab and tremelimumab, given as infusions. These drugs are designed to boost your body's natural defences, its immune system, to recognise and fight cancer cells more effectively. Researchers are hoping that combining these two different types of treatment might be more effective than either one alone.

The study has two main parts. In the first part (Phase 1), the doctors will be very carefully watching how patients react to different doses of the oral vinorelbine when given with the set doses of the immunotherapy. The main goal here is to find the highest dose of vinorelbine that can be given safely without causing too many serious side effects. Once that safe dose is found, the second part of the study (Phase 2) will focus on how well this new combination treatment works to control the cancer, such as shrinking tumours or stopping their growth, and continuing to monitor for any side effects.

Key takeaways

This study evaluates a new combination of chemotherapy (vinorelbine) and immunotherapy (durvalumab + tremelimumab).
It's for adults with advanced solid tumours.
The first part finds the safest dose, and the second part checks how well it works.
Patients will receive oral medication and infusions, with close medical monitoring.
Potential benefits include access to new treatment; risks include side effects.
You can withdraw from the study at any time without affecting your ongoing care.

Who may be eligible?

To join this study, you must be an adult aged 18 or older. The study is open to both men and women.

Critically, you must have a type of cancer that is considered "locally advanced" (meaning it has grown significantly in one area) or "metastatic" (meaning it has spread to other parts of your body, creating new tumours). The study is looking for people with "solid tumours," which are cancers that form a lump, rather than blood cancers like leukaemia.

There will be other, more detailed criteria that your doctor will check to make sure the study treatment is safe and suitable for you. These might include your general health, how well your organs are working, and any other medical conditions you might have. It's important to discuss all your health information with the study doctor.

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 a diagnosis of a solid tumour (not a blood cancer)?
Has your cancer been described as 'locally advanced' or 'metastatic' (spread)?
Are you able to attend regular hospital visits for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to participate in this study, you would receive the new combination treatment, which includes oral vinorelbine and infusions of durvalumab and tremelimumab. You would have regular visits to the hospital or clinic for these infusions and to pick up your oral medication. Throughout the study, the medical team will closely monitor your health. This will involve regular blood tests, check-ups, and scans to see how your cancer is responding to the treatment and to keep an eye on any side effects.

The first part of the study focuses on finding the right dose, so your dose of vinorelbine might be adjusted based on how you react. In the second part, the focus will be on the effectiveness of the treatment. The total duration of your participation in the study would depend on how your body responds to the treatment and the study's monitoring schedule. You would continue to be monitored for side effects and how your cancer is doing for at least 24 weeks, and likely longer if the treatment is benefiting you.

Potential risks and benefits

Participating in a clinical trial offers the potential benefit of accessing a new treatment that isn't yet widely available, which might be effective for your advanced cancer. However, as with all medical treatments, there are potential risks and possible side effects, some of which might be serious or currently unknown for this specific combination. While the research team will closely monitor you to manage any side effects, there is no guarantee that the treatment will be successful or that you will personally benefit. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What kind of cancer is this study for?

This study is for adults with advanced solid tumours, which means cancers that have spread or are significantly grown in one area.

What are 'solid tumours'?

Solid tumours are cancers that form a mass or lump, unlike blood cancers. Examples include lung, breast, or bowel cancer.

What is 'metronomic' therapy?

Metronomic therapy means taking a low, regular dose of a drug, like vinorelbine, over time. It's different from standard, higher doses given less often.

What is 'immunotherapy'?

Immunotherapy uses medicines to help your body's own immune system find and fight cancer cells more effectively.

Will I definitely get the new treatment?

If you join the study, you will receive the combination of metronomic oral vinorelbine, durvalumab, and tremelimumab, as the study aims to test this specific combination. You will not receive a placebo.