Not yet recruitingPHASE2INTERVENTIONAL

Trial of FOLFIRI + Zimberelimab + Domvanalimab vs FOLFIRI With a Hybrid Synthetic Control Arm in Second Line Treatment of Neuroendocrine Carcinoma of Gastro-enteropancreatic or Unknown Origin (REWENEC 01)

This study, called REWENEC 01, is for adults with a rare and aggressive cancer known as neuroendocrine carcinoma, specifically those that started in the gut, pancreas, or where the starting point is unknown. If their cancer has come back after their first treatment, doctors usually try another chemotherapy called FOLFIRI. This study is testing if a new combination of drugs – FOLFIRI plus two immunotherapy drugs called Zimberelimab and Domvanalimab – works better than FOLFIRI on its own. The main goal is to see if more patients are still alive 12 months after starting the new combination compared to those on standard FOLFIRI treatment. This is a Phase 2 trial, meaning it's still in the earlier stages of testing new treatments.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

Hospices Civils de Lyon

Enrolment target

122

Start

01 Apr 2026

Estimated completion

01 Apr 2030

Carcinoma, Neuroendocrine

What is this study about?

Imagine you or someone you know has a rare and aggressive type of cancer called neuroendocrine carcinoma, which often affects the digestive system or pancreas. After the first round of treatment, it's common for this cancer to come back quite quickly. When it does, doctors usually offer a second treatment to try and control it. The current standard second treatment is a chemotherapy called FOLFIRI, but unfortunately, it doesn't always work for a very long time.

This study is trying to find a better option. Researchers are investigating a new treatment that combines the standard FOLFIRI chemotherapy with two special types of drugs called immunotherapies (Zimberelimab and Domvanalimab). Immunotherapies work by helping your body's own immune system fight the cancer. They are particularly interested in combining these drugs because previous studies have shown that some patients' cancers develop ways to hide from the immune system, and these new drugs might help overcome that.

So, the REWENEC 01 study wants to see if this new combination of FOLFIRI plus these two immunotherapy drugs can improve how long people live compared to FOLFIRI alone. Because this cancer is so rare, it's hard to get enough people for big studies. This study uses a clever design that combines information from new patients with details from past patients to help get answers sooner and offer hope for a more effective treatment.

Key takeaways

Tests a new combination treatment for a rare, aggressive cancer.
Compares a new drug mix with standard chemotherapy.
Aims to improve survival for patients whose cancer has returned.
Uses immunotherapy drugs to boost the body's immune response.
Carefully designed to gather valuable information due to the cancer's rarity.
Participation involves regular hospital visits, tests, and monitoring.

Who may be eligible?

This study is looking for men and women, aged 18 and over, who have a specific type of rare cancer called poorly differentiated neuroendocrine carcinoma. This cancer must have started in the digestive system or pancreas, or its original site might be unknown. A key part of joining is that your cancer must have come back or worsened after your first course of chemotherapy treatment (which would have been cisplatin or carboplatin plus etoposide).

To be considered, your cancer needs to be actively growing or shown to have progressed recently, and doctors will need to be able to measure it. Your general health should also be good enough to take part in the study, meaning you can perform most normal daily activities without too much difficulty. You also must not have had any immunotherapy treatments before.

It's important that if you are a woman who could become pregnant, you agree to use effective birth control during and for some time after the study. The same applies to men who are sexually active. Unfortunately, if you are pregnant or breastfeeding, or have certain other medical conditions, you wouldn't be able to join this study.

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?
Do you have poorly differentiated neuroendocrine carcinoma of the gut, pancreas, or unknown origin?
Has your cancer come back or worsened after your first chemotherapy (cisplatin/carboplatin + etoposide)?
Is your general health good enough to manage most daily activities?
Have you never had immunotherapy drugs before?
Are you willing to use effective birth control if you could get pregnant or cause a pregnancy?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to either receive the new combination treatment (FOLFIRI + Zimberelimab + Domvanalimab) or the standard FOLFIRI chemotherapy. This is like flipping a coin to decide, though in this study, more people will receive the new combination. You will have regular hospital visits for treatments, blood tests, and scans to see how the cancer is responding. The total duration of your treatment will depend on how you respond, but you will be monitored and followed up by the study team for some time after your treatment ends to track your health and the cancer's progress.

Potential risks and benefits

Potential benefits of participating could include receiving a new experimental treatment that might be more effective than standard care, and contributing to medical knowledge that could help future patients. However, there are no guarantees that the new treatment will work for you, and it may have different or more side effects than standard FOLFIRI. All treatments carry risks, and the study team will carefully explain the known and potential side effects of all medications. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (21)

CHU Amiens Picardie
Verified postcode
Amiens, France
CHU Avicenne APHP
Verified postcode
Bobigny, France
CHU Caen Normandie
Verified postcode
Caen, France
Hôpital Beaujon
Verified postcode
Clichy, France
Hôpital Henri MONDOR
Verified postcode
Créteil, France
CHU Dijon
Verified postcode
Dijon, France
CHU de Grenoble
Verified postcode
Grenoble, France
Centre Oscar Lambret
Verified postcode
Lille, France
Service d'Oncologie Médicale - Hôpital Edouard Herriot - Hospices Civils de Lyon
Verified postcode
Lyon, France
CHU Timone
Verified postcode
Marseille, France
Institut Paoli Calmettes
Verified postcode
Marseille, France
CHU Montpellier - Hôpital Saint Eloi
Verified postcode
Montpellier, France

Common questions

What is neuroendocrine carcinoma?

It's a rare and aggressive type of cancer that usually starts in the gut, pancreas, or sometimes an unknown place in the body.

What is FOLFIRI?

FOLFIRI is a standard chemotherapy treatment that doctors use for certain cancers, including neuroendocrine carcinoma when it has returned.

What are Zimberelimab and Domvanalimab?

These are immunotherapy drugs. They work by helping your body's own immune system to recognise and fight cancer cells.

Why is this new combination being tested?

Doctors hope that by adding these immunotherapy drugs to FOLFIRI, the treatment will be more effective and help patients live longer compared to FOLFIRI alone.

Will I definitely get the new treatment if I join?

You will be randomly assigned to either the new drug combination or the standard FOLFIRI. More people will receive the new combination.

How to find out more

Thomas WALTER, MD

thomas.walter@chu-lyon.fr 4 72 11 73 98 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.