About this trial

Akkermansia muciniphila is a naturally occurring bacterium found in the healthy human gastrointestinal tract.

Analysis of the gut microbiota of NSCLC or RCC patients shows that the presence of Akkermansia is associated with the clinical efficacy of immunotherapy. In preclinical models, oral administration of the Akkermansia p2261 strain reverses resistance to PD-1 blockade. In the clinical setting, it is therefore hypothesized that the oral administration of Oncobax®-AK to cancer patients under immunotherapy, but whose gut microbiota is deficient in Akkermansia will restore / improve the efficacy of immunotherapy in patients with NSCLC or RCC.

Eligibility criteria

Qualifiers

Age > 18 years

Histologically confirmed Stage IV non-squamous NSCLC or clear cell RCC

NSCLC-specific criterion: Best tumor response (by iRECIST) as Stable Disease

NSCLC-specific criterion: PD-L1 expression > 50%

Disqualifiers

Symptomatic brain metastases

AST or ALT > 5 x ULN

Calculated creatinine clearance < 45 ml/min

Auto-immune diseases requiring systemic therapy

Trial design

Treatments tested in this trial

  • Live Bacterial Product - Akkermansia muciniphila

Treatment groups

122 Participants
are divided into 2 treatment groups

Locations

4
Belgium
CHU Ambroise Paré Mons Belgium
France
Centre Georges Francois Leclerc Dijon France
Institut Gustave Roussy Paris France
ICANS - Institut de cancérologie Strasbourg Strasbourg France

Sponsors and collaborators

EverImmune

Lead sponsor