Active not recruitingPHASE1INTERVENTIONAL

Testing the Combination of Anetumab Ravtansine With Either Nivolumab, Nivolumab and Ipilimumab, or Gemcitabine and Nivolumab in Advanced Pancreatic Cancer

This study is for people with advanced pancreatic cancer where the cancer has spread. Researchers are looking for the safest and most effective dose of a new combination of treatments. The main drug, anetumab ravtansine, is designed to find and destroy cancer cells with a specific marker called mesothelin. It's being tested alongside nivolumab or ipilimumab, which are medicines that help your body's immune system fight cancer, and/or gemcitabine, a common chemotherapy. The aim is to see if using these medications together can improve treatment outcomes for pancreatic cancer patients. This is an early-stage study, checking for side effects and early signs of how well the treatments work.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

National Cancer Institute (NCI)

Enrolment target

Start

09 Dec 2019

Estimated completion

31 Jan 2027

Pancreatic Adenocarcinoma Stage II Pancreatic Cancer AJCC v8 Stage III Pancreatic Cancer AJCC v8 Stage IV Pancreatic Cancer AJCC v8

What is this study about?

This research study is looking into new ways to treat pancreatic cancer that has spread to other parts of the body, or that doctors can't remove with surgery. The main goal is to find out if combining several different drugs can be safer and more effective than current treatments. We hope to find the best dosage of these combined medicines.

The study uses a new drug called anetumab ravtansine. This drug is like a guided missile: it's designed to specifically target cancer cells that have a protein called "mesothelin" on their surface. Once it finds these cells, it delivers a powerful chemotherapy drug directly to them, aiming to kill them while causing less harm to healthy cells. We're also using drugs like nivolumab and ipilimumab. These are a type of medicine called immunotherapy, which works by boosting your body's own immune system to recognise and fight the cancer. Finally, a common chemotherapy drug called gemcitabine may also be used in some combinations. Chemotherapy drugs work in various ways to stop cancer cells from growing and spreading.

By bringing these different types of treatments together, researchers hope to find a more powerful way to tackle pancreatic cancer. They will carefully monitor participants for any side effects and look for early signs that the combination is shrinking the tumour or stopping it from growing. This is a "Phase 1" study, which means it's one of the first human trials, so the main focus is on safety and finding the right dose.

Key takeaways

This study explores new combinations of drugs for advanced pancreatic cancer.
It uses a targeted drug (anetumab ravtansine) and immune-boosting therapies.
The main goals are to find safe doses and see early signs of effectiveness.
Your cancer must have a specific marker called mesothelin to be eligible.
Regular hospital visits and tests will be part of taking part.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you must have pancreatic cancer that has spread or can't be removed by surgery. Your cancer cells must also have a specific marker called "mesothelin." Doctors will check for this marker using a special test.

You should have already received at least one course of treatment for your cancer, and either it didn't work well enough, or you couldn't tolerate the side effects. You need to be at least 18 years old and generally well enough to take part, with a life expectancy of at least three months. Your doctor will assess your overall health to make sure this study is suitable for you.

There are also specific requirements for your previous treatments. For example, you can't have received certain types of immunotherapy recently. You must also have at least one cancerous area that can be measured accurately by scans, and it must be safe for doctors to take a small tissue sample (biopsy) from this area if needed.

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 you have pancreatic cancer that has spread or cannot be removed by surgery?
Has your doctor confirmed that your cancer cells have the 'mesothelin' marker?
Have you already had at least one previous treatment for your cancer?
Are you 18 years old or older?
Are you generally well enough to take part in medical treatments and visits?
Are you comfortable with the idea of having biopsies (tissue samples) taken?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given a combination of study drugs. This will involve regular visits to the hospital for your treatment and to have various tests, such as blood tests, scans (like CT or MRI), and possibly repeat biopsies (taking small tissue samples) to see how the treatment is affecting the cancer and your body. The medical team will closely monitor you for any side effects and to see how the treatment is working. We cannot provide an exact schedule without more details on the specific dose group, but these kinds of studies typically involve frequent visits at the beginning, which may become less frequent over time. The total duration of your participation will depend on how you respond to the treatment and the study's design.

Potential risks and benefits

Participating in this study might offer a chance to receive new treatments for your pancreatic cancer that are not yet widely available. While we hope these combinations will be effective, there's no guarantee that the treatment will work for everyone, or that it will be better than other options. All medications, including those in this study, can have side effects, and some could be serious. The medical team will explain all the known and potential risks to you in detail. You are free to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (45)

University of Alabama at Birmingham Cancer Center
Verified postcode
Birmingham, United States
City of Hope Comprehensive Cancer Center
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Duarte, United States
City of Hope at Irvine Lennar
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Irvine, United States
Keck Medicine of USC Koreatown
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Los Angeles, United States
Los Angeles General Medical Center
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Los Angeles, United States
USC / Norris Comprehensive Cancer Center
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Los Angeles, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
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Orange, United States
University of California Davis Comprehensive Cancer Center
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Sacramento, United States
UCHealth University of Colorado Hospital
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Aurora, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
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Coral Gables, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
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Deerfield Beach, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Verified postcode
Miami, United States

Common questions

What is mesothelin, and why is it important for this study?

Mesothelin is a protein found on the surface of some cancer cells, including certain types of pancreatic cancer. It's important for this study because one of the main drugs, anetumab ravtansine, specifically targets cells that have mesothelin, acting like a key finding a lock.

What does 'advanced' pancreatic cancer mean?

Advanced pancreatic cancer means the cancer has either spread to other parts of your body (metastatic) or is in a location that makes it impossible to remove completely with surgery (unresectable).

Are the drugs in this study new, or are some already used?

Anetumab ravtansine is a newer drug being tested. Nivolumab and ipilimumab are immunotherapies already used to treat some cancers, and gemcitabine is a common chemotherapy drug for pancreatic cancer. This study combines them in new ways.

Will I know which combination of drugs I'm getting?

Yes, this is not a 'blinded' study like some others. Your doctors will know exactly which combination of the study drugs you are receiving and will discuss this with you.

How long will I be on the study treatment?

The length of time you receive treatment will depend on how your cancer responds and how you tolerate the medication. It could continue as long as the treatment is helping and side effects are manageable, or until the study concludes.