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Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus–Pancreatic Cancer)

This research study, called Morpheus–Pancreatic Cancer, is looking into new ways to treat pancreatic cancer that has spread. It's testing several combinations of special medicines, including ones that help your body's immune system fight cancer. The main goal is to find out how well these new drug mixtures work at shrinking tumours and if they are safe for patients. Doctors hope to learn if these treatments can help people live longer and feel better. This is an early-stage study, meaning these treatments are still being investigated.

At a glance

Status
Ongoing, recruiting
Phase
Phase I and Phase II (Integrated)- Other
Sponsor
F. Hoffmann-La Roche AG
Enrolment target
29
Start
04 Apr 2024

What is this study about?

This study is called Morpheus–Pancreatic Cancer, and it's looking for better treatments for pancreatic cancer that has spread to other parts of the body. Pancreatic cancer can be very difficult to treat, so doctors are always looking for new and more effective ways to help patients.

In this study, researchers are testing different combinations of several new medicines. Many of these medicines are a type called 'immunotherapy', which means they work by boosting your body's own immune system to recognise and fight cancer cells. Think of it like giving your body's natural defence system a helpful nudge to target the cancer more effectively. They're also using some other well-known cancer drugs.

The main aim is to see how successful these new drug combinations are at shrinking the cancer (doctors call this 'objective response') and if they are safe. They will also be looking at how long people live, how long they stay well without the cancer getting worse, and how long the treatment keeps the cancer controlled. This information will help doctors understand which combinations might work best for future patients.

Key takeaways

  • This study is testing combinations of drugs, including immunotherapies, for advanced pancreatic cancer.
  • It aims to see how well these new treatments shrink tumours and if they are safe.
  • Doctors will closely monitor participants' health and the cancer's response.
  • Participation involves regular hospital visits for treatment and check-ups.
  • You can withdraw from the study at any time.

Who may be eligible?

To be able to join this study, you need to be an adult, 18 years old or older. The doctors will also check other things about your health and your specific type of pancreatic cancer that has spread. This is to make sure the study treatments are right for you and won't cause any unexpected problems.

For example, they'll look at your overall health, any other medical conditions you might have, and how your body is currently coping with the cancer. These checks are important to keep you safe and to make sure the study results are clear.

Both men and women can take part, as long as they meet all the other health requirements set out by the study doctors. Don't worry if you're not sure; the study team will go through everything with you carefully.

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.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with pancreatic cancer that has spread?
  3. Are you generally well enough to start a new treatment?
  4. Are you able to attend regular hospital appointments?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medication as an infusion (given through a drip into your vein). You'll have regular visits to the hospital or clinic so the doctors and nurses can keep a close eye on you. These visits will involve blood tests, scans to check on your cancer, measurements of your vital signs (like your heart rate and blood pressure), and questions about how you are feeling and any side effects you might be having.

Throughout the study, the medical team will be checking how your cancer responds to the treatment and monitoring your health very closely. The total length of time you'd be involved in the study can vary, depending on how your treatment is going and how long the doctors need to follow up on your health. This is a very active approach to treatment, with regular assessments to ensure your safety and monitor the effects of the medicines.

Potential risks and benefits

Participating in research studies like this can offer potential benefits, such as access to new treatments that aren't yet widely available. While there's no guarantee the treatment will work for everyone, it might help to shrink your tumour or slow its growth. However, there are also potential risks, including side effects from the medications, which could range from mild to severe, as these are powerful medicines. The medical team will explain all known side effects and monitor you closely. You have the right to withdraw from the study at any time, for any reason, without affecting your standard care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Spain

Common questions

What kind of cancer is this study for?

This study is for people with pancreatic cancer that has spread to other parts of the body.

What are 'immunotherapy' drugs?

Immunotherapy drugs help your body's own immune system fight the cancer more effectively.

Will I definitely get one of the new treatments?

Yes, everyone in this study will receive a combination of medicines being tested to treat the cancer.

How often will I need to go to the hospital?

You'll have regular visits for treatments, check-ups, blood tests, and scans, but the exact schedule will be explained by the study team.

Can I leave the study if I want to?

Yes, you can choose to leave the study at any time, for any reason, and your regular medical care will not be affected.

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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