A Phase 2, single arm study on dacarbazine (DTIC) followed by immunotherapy re-challenge in unresectable or metastatic melanoma with primary resistance to PD-1/PD-L1 or PD-1 + CTLA-4 blockade (PROMIT: PReconditioning of TumOr, Tumor Microenvironment and the Immune System to ImmunoTherapy)
This study is for people with melanoma (a serious type of skin cancer) that has spread or can't be removed with surgery. It focuses on patients whose cancer hasn't responded well to standard immunotherapy treatments, which use your body's immune system to fight cancer. The researchers are trying a new approach, giving a chemotherapy drug called dacarbazine first. The idea is that this drug might 'wake up' the tumour and its surroundings, making it more sensitive to immunotherapy. After the dacarbazine, patients will then receive immunotherapy again, using drugs like pembrolizumab, nivolumab, or ipilimumab. The main goal is to see if this combination treatment shrinks tumours or stops them from growing, and how it affects patients' overall health and quality of life. This is a Phase II study, meaning it's an early stage to see if the treatment is promising.
At a glance
What is this study about?
Melanoma is a type of skin cancer that can be very serious, especially if it spreads to other parts of the body or can't be removed by surgery. In recent years, treatments called 'immunotherapy' have become available. These treatments work by boosting your body's own immune system to fight the cancer. While immunotherapy has helped many people, some patients' cancers don't respond to it, or they stop responding over time. When this happens, doctors look for new ways to treat the cancer.
This study, called PROMIT, is looking at a new strategy for people whose melanoma hasn't responded to standard immunotherapy. The researchers believe that by giving a chemotherapy drug called dacarbazine first, they might change the cancer and its surroundings in a way that makes it more open to treatment. Think of it like preparing the ground before planting a seed – the dacarbazine might 'prepare' the cancer so that immunotherapy can work better.
After receiving dacarbazine, participants will then receive a combination of immunotherapy drugs that are already approved treatments for melanoma. The study aims to see if this two-step approach is more effective than immunotherapy alone for patients who haven't responded in the past. We want to understand if this new combination can lead to tumours shrinking or stopping their growth, and ultimately, if it can help people live longer and maintain a good quality of life.
Key takeaways
- This study tries a new approach for melanoma that hasn't responded to previous immunotherapy.
- It combines an existing chemotherapy drug with new immunotherapy drugs.
- The goal is to make immunotherapy more effective against the cancer.
- Participation involves treatments, blood tests, scans, and tissue/blood/stool samples.
- It aims to see if tumours shrink and how it affects patients' overall health and quality of life.
Who may be eligible?
To join this study, you must be an adult with melanoma that has spread or can't be removed with surgery. A key part of joining is that your melanoma must have previously been treated with immunotherapy (drugs that help your immune system fight cancer, like PD-1 or CTLA-4 blockers) but didn't respond well to that treatment, or worsened despite it.
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.
- I have melanoma that has spread or cannot be removed by surgery.
- I am an adult (18 years or older).
- My melanoma has previously been treated with immunotherapy (like PD-1 or CTLA-4 blockers).
- My melanoma did not respond well to that previous immunotherapy treatment, or it got worse.
What does participation involve?
If you decide to take part, you would first receive treatment with a chemotherapy drug called dacarbazine. After this, you would then receive immunotherapy drugs, which could include pembrolizumab, nivolumab, or ipilimumab. The specific drugs and how often you receive them will be explained by the study team. You'll have regular hospital visits for treatments, blood tests, and scans (like CT or MRI) to check how the treatment is working. We will also ask you to provide samples of tissue, blood, and stool (poo) to help us understand the changes happening in your body and the cancer. You will also fill out questionnaires about your quality of life. The study will involve ongoing check-ups for a period of time to track your progress and overall health. The exact duration of your participation will depend on how you respond to the treatment, but follow-up can last for several years.
Potential risks and benefits
Locations (1)
- —UnverifiedGermany
Common questions
What is melanoma?
Melanoma is a serious type of skin cancer that can develop from existing moles or appear as new dark spots on the skin. It can sometimes spread to other parts of the body.
What is immunotherapy?
Immunotherapy is a type of cancer treatment that helps your body's own immune system find and fight cancer cells more effectively.
What does 'unresectable or metastatic' mean?
This means the cancer cannot be completely removed by surgery, or it has spread from where it started to other parts of the body.
What is dacarbazine?
Dacarbazine is a type of chemotherapy drug that has been used to treat melanoma for many years. In this study, it's used to try and make the immunotherapy more effective.
How long will I be in the study?
Your participation will involve regular treatments and check-ups. The exact length depends on how you respond to the treatment, but follow-up can continue for several years.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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