A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)
This research study, called MountainTAP-5, is looking for people with advanced or spreading solid tumours that have a particular genetic change known as an MTAP deletion. The main goal is to test a new study drug, BMS-986504, to understand how safe it is, how well people tolerate it, and if it can help shrink or control their cancer. The study will look at BMS-986504 by itself (monotherapy) and also in combination with other existing cancer treatments. Researchers will also be checking what the medicine does inside the body and if it shows early signs of helping against the cancer. This is a Phase 2 study, meaning it's still in the early stages of testing for effectiveness and safety on a larger group of patients.
At a glance
What is this study about?
This study is called MountainTAP-5 and it's looking into a new treatment for certain advanced or spreading solid tumours. A 'solid tumour' is a mass of abnormal tissue that usually doesn't contain cysts or liquid areas – examples include breast, lung, prostate, and bowel cancers. If your tumour has spread, it's called 'metastatic'. The study focuses on tumours that have a specific genetic feature: a 'homozygous MTAP deletion'. This simply means a particular gene, called MTAP, is missing in your cancer cells. Researchers believe that targeting this genetic change might be a way to fight these specific cancers.
The main medicine being tested is called BMS-986504. The study aims to understand how safe this medicine is, if people can tolerate it well, and if it shows any signs of fighting the cancer. It's designed in two main parts: one part will look at BMS-986504 on its own, and another part will test it alongside other established cancer treatments. This allows researchers to see the effects of BMS-986504 by itself and whether it works even better when combined with other medicines.
Because this is a Phase 2 study, it's still relatively early research. Doctors are trying to find out if BMS-986504 is promising enough to be studied in even larger groups of people. Your participation would help doctors learn more about this potential new treatment, which could benefit future patients with similar cancers.
Key takeaways
- This study is for people with advanced solid tumours that specifically have an MTAP gene deletion.
- It's testing a new drug, BMS-986504, alone and possibly with other cancer medicines.
- The main goals are to check the new drug's safety and see if it helps against cancer.
- Participation involves regular hospital visits for check-ups, blood tests, and scans.
- You might gain access to a new treatment, but there are potential side effects, and it might not work for everyone.
Who may be eligible?
To join this study, you generally need to have a solid tumour that has spread or is advanced, and your tumour must have a specific genetic change called an MTAP deletion. This genetic change would need to be found in a sample of your tumour tissue. You would also typically have tried standard treatments for your cancer, and these treatments are no longer working, or you can't have them for other reasons.
There are also some important health checks you'd need to meet. For example, your general health and how well you can do daily activities would be reviewed; doctors use a scale where being a 0 or 1 means you're generally quite active. Your blood clotting and organ functions (like liver and kidney) would also need to be within healthy ranges.
However, you wouldn't be able to join if you've already had certain types of cancer treatment (PRMT5 or MAT2A inhibitors). If your cancer has spread to your brain, you might not be eligible unless it's been successfully treated and stable for a while without needing strong steroids. Also, if you have certain stomach or gut problems that might stop you from absorbing medicines properly or swallowing pills, you might not be able to take part.
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.
- Do I have an advanced or spreading solid tumour?
- Has my doctor confirmed that my tumour has an 'MTAP gene deletion'?
- Have I already tried standard treatments for my cancer, or am I unable to have them?
- Is my general health good enough for clinical trial participation (e.g., active and able to do most daily tasks)?
- Do I have any active cancer spread to my brain, or any major stomach/gut problems?
- Have I taken specific drugs called PRMT5 or MAT2A inhibitors in the past?
What does participation involve?
If you join this study, you will receive the study medicine, BMS-986504, either on its own or in combination with other anti-cancer drugs. The study is divided into parts; initially, some people will receive BMS-986504 by itself, and others will receive it alongside other treatments. The specific combination of drugs and how they are given will depend on which part of the study you join and your type of cancer. This study is described as 'open-label,' meaning both you and your study doctor will know which treatment you are receiving.
You will have regular visits to the hospital or clinic for assessments, which will include physical exams, blood tests, and scans to monitor your health and how the treatment is working. These tests help doctors check the safety of the medication and any effects it has on your tumour. The exact number of visits and tests will be detailed by the study team. You will continue treatment for as long as it is benefiting you and you are tolerating it well. Following your treatment period, there will be follow-up visits to continue monitoring your health and the long-term effects.
Potential risks and benefits
Locations (58)
- Local Institution - 0096Verified postcodeSan Francisco, United States
- Local Institution - 0182Verified postcodeAurora, United States
- Local Institution - 0122Verified postcodeTampa, United States
- Local Institution - 0178Verified postcodeAtlanta, United States
- Local Institution - 0106Verified postcodeChicago, United States
- Local Institution - 0143Verified postcodeBaltimore, United States
- Local Institution - 0124Verified postcodeBoston, United States
- Local Institution - 0119Verified postcodeAnn Arbor, United States
- Local Institution - 0129Verified postcodeRochester, United States
- Local Institution - 0174Verified postcodeRochester, United States
- Local Institution - 0181Verified postcodeRochester, United States
- Local Institution - 0142Verified postcodeBuffalo, United States
Common questions
What is an 'MTAP deletion'?
It's a specific genetic change where a gene called MTAP is missing in your cancer cells. Researchers are looking at treatments that might work specifically for cancers with this change.
What does 'advanced and/or metastatic solid tumours' mean?
It means the cancer is either in a later stage locally (advanced) or has spread from where it started to other parts of your body (metastatic). A 'solid tumour' is a lump or mass of abnormal tissue.
What is a 'Phase 2' study?
Phase 2 studies are early research that help doctors find out if a new treatment is safe and if it shows promising signs of working for a particular condition.
Will I know if I'm getting the study drug or another treatment?
Yes, this is an 'open-label' study. This means both you and your study doctor will know which treatment you are receiving.
Can I stop participating in the study if I change my mind?
Yes, you can choose to leave the study at any time, for any reason, and it will not affect your standard medical care.
How to find out more
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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