A Study Comparing Navlimetostat (BMS-986504) in Combination With Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine in Participants With Untreated Metastatic Pancreatic Ductal Adenocarcinoma With Homozygous MTAP Deletion (MountainTAP-30)
This research study, called MountainTAP-30, is testing a new medication called Navlimetostat (also known as BMS-986504) for people with advanced pancreatic cancer that hasn't been treated yet. The new drug is given alongside a common treatment combination of Nab-paclitaxel and Gemcitabine. We want to see if adding Navlimetostat is safe and works better than the standard treatment alone. This study focuses on patients whose pancreatic cancer has a specific genetic feature called a homozygous MTAP deletion, which means a certain gene is missing. If you have this type of pancreatic cancer, this study might be an option to explore.
At a glance
What is this study about?
This study, called MountainTAP-30, is investigating a new treatment approach for pancreatic cancer that has spread to other parts of the body (this is called metastatic pancreatic cancer). We know that pancreatic cancer can be very challenging to treat, and researchers are always looking for new and more effective ways to help patients.
The main goal of this study is to test a new drug called Navlimetostat (you might also see it referred to as BMS-986504). This new drug works in a specific way by targeting a particular feature found in some cancer cells. In this study, Navlimetostat will be given alongside a widely used combination of chemotherapy drugs, Nab-paclitaxel and Gemcitabine. The study compares giving Navlimetostat plus standard chemotherapy versus giving a placebo (a dummy drug that looks like Navlimetostat but has no active ingredients) plus standard chemotherapy. This helps us understand if the new drug makes a difference.
This study is specifically for people whose pancreatic cancer has a genetic change called a 'homozygous MTAP deletion'. This means a certain gene, called MTAP, is missing from the cancer cells. Researchers believe that Navlimetostat might be particularly effective in treating cancers with this specific genetic change. By participating, you could help us learn more about this new potential treatment and whether it can improve outcomes for patients with this type of pancreatic cancer.
Key takeaways
- This study is testing a new drug, Navlimetostat, for advanced pancreatic cancer.
- It's for people whose cancer has a specific genetic change called MTAP deletion.
- You would receive either the new drug or a placebo, both with standard chemotherapy.
- The study aims to see if Navlimetostat is safe and more effective.
- Participation involves regular clinic visits for treatment and monitoring.
- You can stop participating at any time if you change your mind.
Who may be eligible?
To join this study, you would need to have pancreatic cancer that has spread to other parts of your body. Importantly, your cancer cells must show a specific genetic change called an MTAP deletion. This can be found by testing a sample of your tumour.
You cannot have started any treatments for your metastatic pancreatic cancer yet. However, if your doctor felt it was necessary, you might have received one cycle of the standard treatment (Nab-paclitaxel and Gemcitabine) before joining the study, as long as it didn't cause severe side effects and your cancer didn't get worse.
There are also some reasons why you might not be able to join, such as having another cancer that needs treatment, or a history of cancer within the last two years. The study team will review all your medical information to see if this study is right for 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.
- Do I have pancreatic cancer that has spread?
- Has my cancer been tested for an MTAP deletion, and does it show a deletion?
- Have I not yet received any treatment for my widespread pancreatic cancer (or only one cycle of Nab-paclitaxel/Gemcitabine that I tolerated well)?
- Am I at least 18 years old?
- Do I have any other cancers or a history of cancer within the last two years?
What does participation involve?
If you decide to take part in this study, you would be randomly assigned to one of two groups: one group receives the new drug Navlimetostat plus the standard chemotherapy (Nab-paclitaxel and Gemcitabine), and the other group receives a placebo (a dummy drug) plus the standard chemotherapy. Neither you nor your doctor will know which group you are in.
Participation will involve regular visits to the clinic for treatments, check-ups, blood tests, and scans (like CT scans) to monitor your health and how the treatment is working. You will continue treatment for as long as it is helping you and you are tolerating it well. After you stop treatment, there will be follow-up visits or calls to keep track of your health. The total duration of your participation will vary depending on how long you receive treatment and the follow-up period, but it could last for many months to a few years.
Potential risks and benefits
Locations (269)
- Mayo Clinic in Arizona - PhoenixVerified postcodePhoenix, United States
- Local Institution - 0365Verified postcodeTucson, United States
- Highlands Oncology GroupVerified postcodeSpringdale, United States
- Scripps Green HospitalVerified postcodeLa Jolla, United States
- Local Institution - 0157Verified postcodeSan Francisco, United States
- Baptist MD Anderson Cancer CenterVerified postcodeJacksonville, United States
- Mayo Clinic in FloridaVerified postcodeJacksonville, United States
- Winship Cancer Institute, Emory UniversityVerified postcodeAtlanta, United States
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb HospitalVerified postcodeMarietta, United States
- St. Luke's Cancer Institute: BoiseVerified postcodeBoise, United States
- Local Institution - 0168Verified postcodeChicago, United States
- Local Institution - 0125Verified postcodeWestwood, United States
Common questions
What is a 'placebo'?
A placebo is an inactive substance or treatment that looks exactly like the real drug being tested, but it doesn't contain any active medicine. It helps researchers understand if the new drug is truly working or if improvements are due to other factors.
What is an MTAP deletion?
An MTAP deletion means that a specific gene called MTAP is missing from your cancer cells. This is a genetic change that can be found by testing your tumour tissue, and it's important for this study because the new drug might work better in cancers with this feature.
Will I definitely get the new drug?
No, because this is a 'randomised' study, you will have an equal chance of receiving either the new drug (Navlimetostat) or the placebo, both in combination with standard chemotherapy. This helps ensure fair comparison.
What does 'untreated metastatic pancreatic cancer' mean?
It means your pancreatic cancer has spread to other parts of your body, and you haven't received any strong, body-wide treatments (like chemotherapy) for this advanced stage of cancer yet.
How long will I be in the study?
The time you spend in the study will depend on how you respond to the treatment and for how long you are able to take it, as well as the follow-up period. It could range from several months to a few 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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