Using Akkermansia muciniphila to enhance immunotherapy in advanced solid tumors
A Phase 1/2 Study of Oncobax®-AK Administered in Combination With Immunotherapy To Patients With Advanced Solid Tumors
This study is testing if taking a special gut bacterium can help adults with advanced lung or kidney cancer get better results from their immunotherapy treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 122 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | EverImmune Industry-sponsored |
| Drugs / interventions | prednisone, immunotherapy |
| Locations | 4 sites (Mons and 3 other locations) |
| Trial ID | NCT05865730 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of oral administration of Akkermansia muciniphila, a beneficial gut bacterium, in patients with advanced non-small cell lung cancer (NSCLC) or renal cell carcinoma (RCC) who are undergoing immunotherapy. The hypothesis is that restoring Akkermansia levels in patients with a deficiency may improve the efficacy of their immunotherapy treatment. Participants must be adults with specific cancer characteristics and a negative stool test for Akkermansia. The study aims to evaluate the potential benefits of this intervention in enhancing treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with Stage IV non-squamous NSCLC or clear cell RCC who have stable disease and specific PD-L1 expression levels.
Not a fit: Patients with symptomatic brain metastases, severe liver dysfunction, or those on immunosuppressive therapy are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the effectiveness of immunotherapy for patients with advanced solid tumors.
How similar studies have performed: While the use of gut microbiota modulation in cancer treatment is an emerging field, this specific approach with Akkermansia muciniphila is novel and has not been extensively tested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Mons and 3 other locations
- CHU Ambroise Paré — Mons, Belgium (Recruiting)
- Centre Georges Francois Leclerc — Dijon, France (Recruiting)
- Institut Gustave Roussy — Paris, France (Recruiting)
- ICANS - Institut de cancérologie Strasbourg — Strasbourg, France (Recruiting)
Study contacts
- Principal investigator: Fabrice Barlesi, MD, PhD — Gustave Roussy, Cancer Campus, Grand Paris
- Study coordinator: Alain Thibault, MD
- Email: alain.thibault@everimmune.com
- Phone: +32472196345
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.