A Study in Advanced or Metastatic Gastrointestinal Cancers Exploring Treatment Combinations With Pelareorep and Atezolizumab
This research study is looking into new ways to treat advanced or spreading cancers of the digestive system, such as anal cancer and pancreatic cancer. We are testing different combinations of existing and new drugs, including Pelareorep and Atezolizumab, to see how safe they are and if they can help patients. The study is particularly interested in understanding how these treatments affect the body’s immune system to fight cancer. Some parts of the study involve comparing treatments, while others explore new combinations. This is an early-stage study, meaning we are still learning a lot about these treatments, but we hope to find better options for patients.
At a glance
What is this study about?
This study is designed to explore new treatment approaches for advanced cancers that affect the digestive system, like anal cancer and pancreatic cancer, when they have spread to other parts of the body. We are specifically looking at combinations of drugs, including Pelareorep and Atezolizumab, which work in different ways to fight cancer. Pelareorep is a type of virus that aims to make cancer cells more visible to the immune system, while Atezolizumab is an immunotherapy that helps your immune system recognize and attack cancer cells.
The main goals are to find out how safe these new drug combinations are and to see if they can help shrink tumors or stop them from growing. We are also looking for early signs (called 'biomarkers') that might predict which patients will respond best to these treatments. By combining these drugs, we hope to 'prime' the cancer environment, making the immune system more effective at fighting the disease. This could potentially lead to better outcomes for patients.
This is a 'Phase 1/2' study, which means it's an early step in testing new treatments. Phase 1 focuses heavily on safety, while Phase 2 starts to look more closely at how well the treatment works. The study is divided into several groups, with some comparing different treatments and others trying new combinations. If a treatment shows promise in an early stage, more patients might be invited to join that group to learn more.
Key takeaways
- Researchers are testing new drug combinations for advanced anal and pancreatic cancers.
- The study aims to check the safety and effectiveness of treatments like Pelareorep and Atezolizumab.
- It's an early-stage study (Phase 1/2), focusing on finding promising new options.
- Participation involves regular hospital visits for treatments and checks.
- Patients can withdraw from the study at any time without affecting their medical care.
Who may be eligible?
To join this study, people generally need to be at least 18 years old and in reasonably good health despite their cancer. This means you should be able to carry out most of your usual daily activities without too much difficulty. Doctors will also check that your blood, kidney, and liver test results are within certain healthy ranges. If you've had side effects from previous treatments, these must have mostly cleared up.
There are also reasons why someone might not be able to join. For example, if you've recently had chemotherapy, radiotherapy, or surgery (within the last 4 weeks), you might need to wait. Patients who have had certain immunotherapy drugs before, or who have serious heart problems, active infections, or uncontrolled autoimmune diseases, might not be suitable. Women who are pregnant or breastfeeding cannot take part. Additionally, some specific health conditions, like severe lung disease or certain unhealed injuries, would mean you couldn't join. For some parts of the study, there are extra checks, like for particular infections or specific genetic conditions.
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 18 years old or older?
- Are you able to do most of your daily activities without much trouble?
- Have any side effects from your previous treatments mostly cleared up?
- Have you *not* had chemotherapy, radiotherapy, or surgery in the last 4 weeks?
- Have you *not* received certain immunotherapy drugs before?
- Are you *not* pregnant or breastfeeding?
What does participation involve?
If you decide to take part, you will have regular visits to the hospital for examinations, blood tests, and scans to check your health and how the treatment is working. The specific drugs you receive will depend on which group you are in, and these will be given either through a drip (intravenously) or as tablets. You will also have follow-up appointments after your treatment ends to monitor your long-term health. The total duration of your participation could vary, but you would be regularly assessed, and the study team would discuss the full schedule with you. You would need to use effective contraception if you are a woman who could become pregnant or a man with a partner who could become pregnant, and continue this for 6 months after your last study drug dose.
Potential risks and benefits
Locations (15)
- Nationales Centrum für Tumorerkrankungen HeidelbergVerified postcodeHeidelberg, Germany
- SLK-Kliniken Heilbronn GmbHVerified postcodeHeilbronn, Germany
- Universitätsklinikum TübingenVerified postcodeTübingen, Germany
- Universitätsklinikum UlmVerified postcodeUlm, Germany
- Gemeinschaftspraxis Dr. Med Bernhard HeinreichVerified postcodeAugsburg, Germany
- Klinikum der Universität MünchenVerified postcodeMünchen, Germany
- Hämatologisch-Onkologische Praxis EppendorfVerified postcodeHamburg, Germany
- Asklepios Kliniken Hamburg GmbHVerified postcodeHamburg, Germany
- Krankenhaus NordwestVerified postcodeFrankfurt am Main, Germany
- St. Josef-Hospìtal, BochumVerified postcodeBochum, Germany
- Universitätsmedizin MainzVerified postcodeMainz, Germany
- Caritasklinikum Saarbrücken St. TheresiaVerified postcodeSaarbrücken, Germany
Common questions
What kind of cancers is this study for?
This study is for advanced or spreading cancers of the digestive system, specifically anal cancer and pancreatic cancer.
What are Pelareorep and Atezolizumab?
Pelareorep is a type of virus being tested to help your immune system fight cancer. Atezolizumab is an immunotherapy drug that also helps your immune system recognize and attack cancer cells.
Will I definitely get the new drugs?
The study has several groups. Some groups will receive the new drug combinations, while others might receive standard treatments or different combinations, depending on the study design. Your doctor will explain which group you might be in.
How long will I be in the study?
The exact duration can vary. You will have regular treatment cycles and follow-up appointments. The study team will discuss your specific schedule with you.
Can I leave the study at any time?
Yes, you are free to leave the study at any point and for any reason. Your decision will not affect your future medical care.
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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