RecruitingPHASE2INTERVENTIONAL

A Study of Oncobax®-AK in Patients With Advanced Solid Tumors

Researchers are studying whether a beneficial gut bacteria, Akkermansia muciniphila (Oncobax®-AK), can improve the effectiveness of immunotherapy for people with advanced lung cancer (non-small-cell lung carcinoma) or kidney cancer (renal cell carcinoma). It's known that having Akkermansia in the gut can sometimes help immunotherapy work well. This trial will give Oncobax®-AK to patients whose gut levels of this bacteria are low, hoping to boost how their immunotherapy treatment performs. The aim is to see if this natural product can help overcome resistance to immunotherapy and give patients a better chance of response.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

EverImmune

Enrolment target

122

Start

01 Oct 2022

Estimated completion

01 Jun 2026

Carcinoma, Renal Cell Carcinoma, Non-Small-Cell Lung

What is this study about?

This study is investigating a new way to potentially improve cancer treatment for people with advanced lung or kidney cancer. It focuses on a type of good bacteria called Akkermansia muciniphila, which naturally lives in our gut and plays an important role in our health. Researchers have noticed that in people with certain cancers, having enough Akkermansia in the gut seems to be linked to how well their immunotherapy treatment works.

Immunotherapy is a powerful cancer treatment that helps your body’s own immune system fight cancer cells. However, it doesn't work for everyone. This study is testing the idea that if a person's gut doesn't have enough Akkermansia, giving them more of this beneficial bacteria (in the form of a product called Oncobax®-AK) could help their immunotherapy become more effective. Scientists have seen promising signs in lab tests that this approach might help overcome situations where immunotherapy isn't working as well as hoped.

The main goal is to find out if Oncobax®-AK can restore or improve the effectiveness of immunotherapy in patients with non-small cell lung cancer or clear cell kidney cancer, particularly if their natural levels of Akkermansia are low. This research is in Phase 2, meaning it’s already been tested for safety in a smaller group and is now looking at how well it works and continues to monitor for side effects.

Key takeaways

This study uses a specific gut bacteria, Oncobax®-AK, to try and boost immunotherapy for certain advanced cancers.
It's for people with advanced lung (non-squamous NSCLC) or kidney (clear cell RCC) cancer.
A key requirement is having low levels of Akkermansia bacteria in your gut.
The goal is to see if this can make immunotherapy more effective.
It's a Phase 2 trial, focusing on treatment effectiveness and safety.

Who may be eligible?

To join this study, you need to be an adult over 18 years old. You must have advanced non-small cell lung cancer that hasn't worsened or clear cell kidney cancer. For lung cancer patients, your specific type should be non-squamous and your tumour should show a certain level of a marker called PD-L1. Your general health should be good enough for you to move around and do most daily activities easily.

Crucially, a test of your stool (poo sample) must show that you have very low or no Akkermansia bacteria in your gut. Your blood tests for things like haemoglobin (blood count), albumin (protein levels), and liver/kidney function also need to be within a healthy range. You'll also need to have at least one tumour that can be measured to track the treatment's effects.

There are also some reasons why you wouldn't be able to join. For example, if your cancer has spread to your brain and is causing symptoms, or if you have severe active infections. Certain other health conditions like autoimmune diseases needing strong medication, recent high-dose radiation to the lungs, or being pregnant would also mean you can't take part. You must be able to follow all the study's instructions.

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 advanced non-small cell lung cancer (non-squamous) or clear cell kidney cancer?
Has your stool test shown very low or no Akkermansia bacteria?
Is your general health good, allowing you to do most daily activities easily?
Are you currently receiving or being considered for immunotherapy?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve several visits to the clinic for assessments. You would be given the study treatment, Oncobax®-AK, which is a live bacterial product. These visits would include blood tests, symptom checks, and possibly scans to see how your tumour is responding. You would also need to provide stool samples to check your Akkermansia levels. The total duration of your participation would depend on how your treatment is progressing and the study's follow-up plan, but typically clinical trials involve regular check-ups over a period of many months.

Potential risks and benefits

Potential benefits of taking part might include improved effectiveness of your existing immunotherapy treatment, and you would be contributing to new medical knowledge that could help others in the future. However, there's no guarantee the treatment will work for you. As with all medical treatments, there could be side effects or risks from the Oncobax®-AK, although good bacteria usually have a good safety record. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

CHU Ambroise Paré
Verified postcode
Mons, Belgium· Recruiting
Centre Georges Francois Leclerc
Verified postcode
Dijon, France· Recruiting
Institut Gustave Roussy
Verified postcode
Paris, France· Recruiting
ICANS - Institut de cancérologie Strasbourg
Verified postcode
Strasbourg, France· Recruiting

Common questions

What is immunotherapy?

Immunotherapy is a treatment that helps your body's own immune system find and fight cancer cells more effectively.

What is Akkermansia muciniphila?

It's a type of good bacteria naturally found in your gut that's thought to be important for gut health and potentially for how well some cancer treatments work.

What kind of cancer patients can join?

This study is for people with advanced non-small cell lung cancer or clear cell kidney cancer.

How will I know if I have low Akkermansia?

The study will do a special test on a stool (poo) sample to check your levels before you can join.

What does 'Phase 2' mean for a trial?

Phase 2 means the study is mainly looking at how well a treatment works and continuing to check its safety, after it's already shown to be safe in a smaller group.

How to find out more

Alain Thibault, MD

alain.thibault@everimmune.com +32472196345 Official trial record

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