A Study of Oncobax®-AK in Patients With Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEverImmune
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 groupsSponsors and collaborators
Source ClinicalTrials.gov