Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan in Combination with FOLFOX Compared to Standard of Care in Subjects with First-Line Metastatic Pancreatic Ductal Adenocarcinoma - AndroMETa-PDAC-288
This study is looking at a new treatment approach for people newly diagnosed with advanced pancreatic cancer that has spread to other parts of the body (metastatic pancreatic cancer). The trial tests a new medicine called telisotuzumab adizutecan given alongside a common chemotherapy combination called FOLFOX. Telisotuzumab adizutecan is designed to find cancer cells and deliver treatment directly to them. Researchers want to find out if giving this drug with FOLFOX works better than the current standard chemotherapy treatments. They will measure whether it shrinks tumours, helps patients live longer, and how it affects everyday quality of life. Participants are randomly placed into groups to receive either the new combination or the usual standard care chemotherapy. Everyone in the trial receives active cancer treatment; no one receives an inactive dummy treatment (placebo).
At a glance
What is this study about?
Pancreatic cancer can be difficult to treat, especially when it has spread beyond the pancreas to other areas of the body. When cancer spreads, doctors call it metastatic cancer. The usual first treatment is chemotherapy, which aims to slow the cancer down and relieve symptoms. While standard treatments help, researchers are working hard to find newer, more effective options that help people live longer, better lives.
This trial tests an experimental medicine called telisotuzumab adizutecan. This type of treatment is known as an antibody-drug conjugate. It works a bit like a guided missile: an antibody tracks down specific proteins on the surface of pancreatic cancer cells and delivers a powerful cancer-killing medicine straight inside them. In this study, doctors are combining it with FOLFOX, an established chemotherapy treatment.
Taking part in this study helps researchers compare the new treatment combination directly against the best standard chemotherapy treatments available today. By comparing both approaches, the trial will show whether the new medicine offers a real improvement in slowing down cancer growth and maintaining day-to-day quality of life.
Key takeaways
- Tests a new targeted medicine (telisotuzumab adizutecan) combined with chemotherapy for advanced pancreatic cancer.
- Aimed at adults who are starting their first treatment for metastatic pancreatic cancer.
- Compares the new treatment directly with current standard chemotherapy care.
- Everyone receives active cancer treatment; no one receives a placebo.
- Participation is entirely voluntary and you can withdraw at any time.
Who may be eligible?
This study is designed for adults aged 18 and over who have recently been diagnosed with metastatic pancreatic ductal adenocarcinoma (the most common form of pancreatic cancer that has spread). It is aimed at people who are about to start their very first chemotherapy treatment for advanced cancer.
To take part, you must be well enough to carry out daily activities and attend regular hospital visits. Your medical team will check that your major organs, such as your heart, liver, and kidneys, are working safely enough to handle chemotherapy.
You may not be eligible if you have already had chemotherapy for your advanced cancer, or if you have other serious medical conditions that would make the treatment unsafe. Your hospital doctor will review your full medical history and scans to confirm whether the study is suitable 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.
- I am aged 18 or older.
- I have been diagnosed with pancreatic ductal adenocarcinoma that has spread (metastatic).
- I have not yet started chemotherapy for my advanced cancer.
- I am well enough to manage my daily routine and travel to the hospital.
- I am willing to undergo regular scans, blood tests, and health questionnaires.
What does participation involve?
Taking part in this trial involves receiving your cancer treatment at the hospital through an intravenous drip into a vein. Treatments are usually given in cycles every two weeks. Because this is a randomised study, a computer will assign you to receive either the new drug combination or standard chemotherapy.
You will have regular hospital visits for treatment and health checks. These checks include blood tests, physical examinations, and regular CT or MRI scans to see how your tumour is responding. You will also be asked to complete short questionnaires about how you are feeling and your overall quality of life.
You will continue receiving treatment for as long as it is helping you and the side effects remain manageable. After you finish treatment, the study team will continue to stay in touch with you to check on your health and wellbeing.
Potential risks and benefits
Locations (6)
- —UnverifiedPortugal
- —UnverifiedSpain
- —UnverifiedFrance
- —UnverifiedItaly
- —UnverifiedGermany
- —UnverifiedAustria
Common questions
Will I receive a placebo (dummy drug)?
No. Everyone taking part in this trial receives active cancer treatment. You will receive either the new medicine combined with chemotherapy or the current standard chemotherapy.
What does 'randomised' mean?
It means a computer randomly decides which treatment group you join, like flipping a coin. This ensures the study results are completely fair and scientifically accurate.
How is the treatment given?
All the study medicines are given as an infusion through a drip into a vein, usually during a day visit to the hospital clinic.
Can I leave the study if I change my mind?
Yes. Taking part is completely voluntary. You can choose to stop at any time without giving a reason, and your doctor will discuss standard treatment options with you.
Do I have to pay for the trial treatment?
No. All trial medications and required study tests are provided free of charge, and some travel expenses may be reimbursed by the trial team.
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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