Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell
Conditions
Brief summary
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.
Interventions
OTHERLive Bacterial Product - Akkermansia muciniphila
Oral administration of Oncobax-AK to patients deficient in Akkermansia by stool metagenomic analysis.
Sponsors
EverImmune
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
1 cohort of patients with NSCLC recruited in parallel to 1 cohort recruiting RCC patients.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \> 18 years 2. Histologically confirmed Stage IV non-squamous NSCLC or clear cell RCC 3. NSCLC-specific criterion: Best tumor response (by iRECIST) as Stable Disease 4. NSCLC-specific criterion: PD-L1 expression \> 50% 5. ECOG Performance Status = 0-1 6. Negative stool PCR test for Akkermansia 7. At least one measurable lesion per iRECIST 8. Hemoglobin ≥ 100 g/L 9. Albumin \> 35 g/L 10. Signed informed consent
Exclusion criteria
1. Symptomatic brain metastases 2. AST or ALT \> 5 x ULN 3. Calculated creatinine clearance \< 45 ml/min 4. Auto-immune diseases requiring systemic therapy 5. Immunosuppressive therapy (\> 10 mg prednisone/day equivalent) 6. Radiotherapy (\> 30 Gy) to the lung(s) within 6 months of signed informed consent 7. Active infection 8. Co-morbidities that may increase the risk of treatment-related adverse events 9. Pregnancy 10. Inability to comply with protocol-specific assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | 9 months | iRECIST |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 9 months | iRECIST |
Countries
Belgium, France
Contacts
Primary ContactAlain Thibault, MD
Outcome results
None listed