A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma
This research study is for people with advanced melanoma, a type of skin cancer that has spread or can't be removed by surgery. The main aim is to compare a new way of giving two medicines, nivolumab and relatlimab. Currently, these treatments are given through a drip into a vein (intravenously). This study wants to find out if giving them as an injection under the skin (subcutaneously) works just as well. The idea is that injections might be more convenient and comfortable for patients than regular vein drips, potentially making treatment a bit easier to manage.
At a glance
What is this study about?
This study is investigating a new way to give treatment for a type of skin cancer called melanoma, specifically when it's advanced. Advanced melanoma means the cancer has either spread to other parts of the body (metastatic) or it cannot be surgically removed (unresectable). The treatment involves two medicines called nivolumab and relatlimab.
Currently, these medicines are often given through a drip directly into a vein, which is known as an intravenous (IV) infusion. This study wants to explore if giving the same medicines as an injection under the skin (subcutaneous or SC) works just as effectively. The main goal is to show that the level of medicine in the body after an injection is similar to the level after a vein drip.
The reason for exploring an under-the-skin injection is to potentially make treatment more convenient for patients. If it works just as well, it could mean shorter hospital visits and a more comfortable way to receive the medication compared to the longer time needed for an IV drip. This study is an important step to see if this new, simpler method can be a good option for future treatments.
Key takeaways
- This study aims to make advanced melanoma treatment more convenient.
- It compares an under-the-skin injection to a vein drip for existing medicines.
- Participation involves regular clinic visits, treatments, and health checks.
- You need to have advanced melanoma and be at least 12 years old.
- You can stop participating at any time.
Who may be eligible?
To join this study, participants generally need to be at least 12 years old. If you're between 12 and 18, you also need to weigh at least 40 kg. You must have been diagnosed with advanced melanoma, either Stage III that can't be removed, or Stage IV which means it has spread. Your general health and ability to do daily activities should be quite good, as assessed by a doctor.
There are some reasons why you might not be able to join. For example, if you have a specific type of eye melanoma, or if you've had a heart condition called myocarditis. Also, if you're taking high doses of certain medications that affect your immune system, you might not be eligible. The study team will check all these details carefully with you.
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 at least 12 years old?
- Do you have advanced melanoma (Stage III unresectable or Stage IV)?
- Are you generally feeling well with good daily activity levels?
- Have you *not* had certain heart conditions like myocarditis?
- Are you *not* currently taking high doses of steroid medications or other strong immune-suppressing drugs?
What does participation involve?
If you join this study, you will receive the usual combination therapy (nivolumab + relatlimab) either as an injection under the skin or through a drip into a vein. The study team will explain which method you'll receive. You will have regular visits to the clinic for your treatments and check-ups. These visits will involve blood tests, physical examinations, and scans (like CT or MRI scans) to see how you're responding to the treatment and to monitor your health.
The exact number and timing of visits will depend on how your treatment progresses, but you should expect regular appointments. There will also be follow-up appointments after your treatment ends to continue monitoring your health. The total duration of your participation in the study, including follow-up, will be determined by the study plan and your individual response. All procedures will be explained in detail by the study team.
Potential risks and benefits
Locations (149)
- Local Institution - 0125Verified postcodePhoenix, United States
- Local Institution - 0189Verified postcodeSpringdale, United States
- Local Institution - 0098Verified postcodeLos Angeles, United States
- Local Institution - 0093Verified postcodeOrange, United States
- Local Institution - 0123Verified postcodeStanford, United States
- Local Institution - 0113Verified postcodeEnglewood, United States
- Local Institution - 0114Verified postcodeJacksonville, United States
- Local Institution - 0146Verified postcodeBaltimore, United States
- Local Institution - 0071Verified postcodeRochester, United States
- Local Institution - 0013Verified postcodeOmaha, United States
- Local Institution - 0169Verified postcodeCleveland, United States
- Local Institution - 0139Verified postcodeEaston, United States
Common questions
What is melanoma?
Melanoma is a serious type of skin cancer that starts in cells that make pigment (the colour) in your skin. When it's advanced, it means it has spread or is hard to remove.
What does 'subcutaneous' mean?
'Subcutaneous' means under the skin. So, a subcutaneous injection is medicine given with a small needle, just beneath the skin's surface.
What does 'intravenous' mean?
'Intravenous' means into a vein. This kind of treatment is usually given through a drip in your arm.
Are the medicines new?
Nivolumab and relatlimab are already used for melanoma. This study is looking at a new way to give them, not entirely new medicines themselves.
Who is running this study?
This study is sponsored by Bristol-Myers Squibb, a pharmaceutical company, and approved by health authorities.
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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