Actively Recruiting
A Study of Oncobax®-AK in Patients With Advanced Solid Tumors
Led by EverImmune · Updated on 2023-05-19
122
Participants Needed
4
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Oncobax®-AK in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18 years
- Histologically confirmed Stage IV non-squamous NSCLC or clear cell RCC
- Stable disease status by iRECIST for NSCLC
- PD-L1 expression > 50% for NSCLC
- ECOG Performance Status of 0 or 1
- Negative stool PCR test for Akkermansia
- At least one measurable lesion per iRECIST
- Hemoglobin level 63 100 g/L
- Albumin level > 35 g/L
- Signed informed consent
You will not qualify if you...
- Symptomatic brain metastases
- AST or ALT levels > 5 times the upper limit of normal
- Calculated creatinine clearance < 45 ml/min
- Autoimmune diseases needing systemic therapy
- Immunosuppressive therapy over 10 mg prednisone/day equivalent
- Radiotherapy over 30 Gy to the lungs within 6 months
- Active infection
- Co-morbidities increasing risk of treatment-related adverse events
- Pregnancy
- Inability to comply with study assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
CHU Ambroise Paré
Mons, Belgium
Actively Recruiting
2
Centre Georges Francois Leclerc
Dijon, France
Actively Recruiting
3
Institut Gustave Roussy
Paris, France
Actively Recruiting
4
ICANS - Institut de cancérologie Strasbourg
Strasbourg, France
Actively Recruiting
Research Team
A
Alain Thibault, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here