MOIO_Randomized phase III trial of standard immunotherapy (IO) by checkpoint inhibitors, versus reduced dose intensity of IO in patients with locally advanced or metastatic cancer in response after 6 months of standard IO
This study is for people with certain advanced or metastatic cancers (like lung, kidney, or breast cancer) who have responded well to standard immunotherapy for at least six months. It aims to see if reducing the dose of immunotherapy can be just as effective as continuing the standard dose, while potentially having fewer side effects. Researchers will compare how long people stay well without their cancer getting worse (called 'progression-free survival'). They will also look at overall survival, how many people respond to treatment, and their quality of life. The study hopes to find the best way to continue treating cancer while keeping people feeling as good as possible.
At a glance
What is this study about?
This clinical trial, called MOIO, is looking into how best to continue treating certain advanced cancers after they've responded well to initial immunotherapy. Immunotherapy is a type of treatment that uses your body's own immune system to fight cancer. The study is for people whose cancer is locally advanced (meaning it has spread nearby) or metastatic (meaning it has spread to other parts of the body).
If you've been on standard immunotherapy and your cancer has improved or stayed stable for at least six months, this study might be for you. The main question researchers want to answer is: can people continue to do just as well with a reduced dose of immunotherapy as they would with the usual full dose? This is important because reducing the dose might also reduce side effects, making treatment more manageable in the long term, while still being effective.
Researchers will compare two groups: one receiving the standard dose of their immunotherapy and another receiving a reduced dose. They will carefully monitor how long people stay healthy without their cancer growing (this is called 'progression-free survival') and will also look at their overall health, quality of life, and any side effects they experience. This information will help doctors understand the best way to tailor immunotherapy for patients in the future.
Key takeaways
- This study evaluates different immunotherapy doses for patients whose cancer previously responded well.
- It aims to see if a reduced dose can be as effective as a standard dose.
- The study includes various types of advanced or metastatic cancers.
- It will track how long patients stay well, their overall survival, and quality of life.
- Participation involves regular check-ups, scans, and questionnaires over several years.
Who may be eligible?
This study is looking for adults aged 18 or older, men and women, who have a specific type of advanced or metastatic cancer. This includes various cancers like lung, kidney (unless it's a specific low-risk type treated in a certain way), head and neck, bladder, triple negative breast, Merkel cell, melanoma, liver, colorectal (with a certain genetic marker), oesophageal, endometrial, cervical, stomach, basal cell, or squamous skin cancer.
Crucially, to be considered for this study, your cancer must have responded positively to your current standard immunotherapy treatment. This means that after at least six months of immunotherapy (which could have been given alone or with other treatments like chemotherapy), your cancer must be in either a complete or partial response. For melanoma, only partial response is considered.
If your doctor thinks you meet these general criteria and your cancer fits one of the listed types, they can help determine if this trial might be suitable for you.
- Are you 18 years old or older?
- Do you have advanced or metastatic lung, kidney, head & neck, bladder, triple negative breast, Merkel, melanoma, liver, specific colorectal, oesophageal, endometrial, cervical, stomach, basal, or squamous skin cancer?
- Has your cancer shown improvement (partial or complete response) after at least 6 months of standard immunotherapy?
- Are you willing to be randomly assigned to receive either a standard or reduced dose of your immunotherapy medicine?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you will be randomly assigned to one of two groups: either you will continue with your standard immunotherapy dose, or you will receive a reduced dose. You won't choose which group you're in, it's decided by chance like flipping a coin. The study will use one of several common immunotherapy drugs like avelumab, dostarlimab, atezolizumab, cemiplimab, nivolumab, pembrolizumab, or durvalumab, depending on what you've already been receiving.
Throughout the study, you'll have regular hospital visits for check-ups, scans (like CT scans, MRI, or PET scans), and to answer questions about your health and how you're feeling. These visits will help doctors track your cancer, look for any side effects, and understand your quality of life. You'll fill out questionnaires about your well-being, anxiety, and fear of cancer returning at various points over approximately three years. The total length of your participation will depend on how your cancer responds to treatment and overall follow-up, which could be up to 36 months after you start the study.
Potential risks and benefits
Locations (1)
- —France
Common questions
What is immunotherapy?
Immunotherapy is a type of cancer treatment that helps your body's own immune system fight cancer cells more effectively.
What does 'locally advanced or metastatic' mean?
Locally advanced means the cancer has grown into nearby tissues. Metastatic means the cancer has spread from where it started to other parts of the body.
What does 'partial or complete response' mean?
A 'complete response' means all signs of your cancer have disappeared. A 'partial response' means your cancer has shrunk but is still present.
Why would my immunotherapy dose be reduced?
Researchers are investigating if a lower dose can be just as effective as the standard dose, which could help reduce side effects and make treatment more manageable while still controlling your cancer.
Will I know if I'm getting the standard or reduced dose?
No, you will be randomly assigned to one of the groups, so you won't know which dose you're receiving. This helps make the study fair and accurate.
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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