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Trial Title:
A Study of Oncobax®-AK in Patients With Advanced Solid Tumors
NCT ID:
NCT05865730
Condition:
Carcinoma, Renal Cell
Carcinoma, Non-Small-Cell Lung
Conditions: Official terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Carcinoma, Renal Cell
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
1 cohort of patients with NSCLC recruited in parallel to 1 cohort recruiting RCC
patients.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Live Bacterial Product - Akkermansia muciniphila
Description:
Oral administration of Oncobax-AK to patients deficient in Akkermansia by stool
metagenomic analysis.
Arm group label:
Phase 2 - NSCLC
Arm group label:
Phase 2 -RCC
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU Ambroise Paré
Address:
City:
Mons
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Stephane Holbrechts, MD
Facility:
Name:
Centre Georges Francois Leclerc
Address:
City:
Dijon
Country:
France
Status:
Recruiting
Contact:
Last name:
Francois Ghiringhelli, MD, PhD
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Paris
Country:
France
Status:
Recruiting
Contact:
Last name:
Laurence Albiges, MD, PhD
Investigator:
Last name:
Lisa Derosa, Md, PhD
Email:
Sub-Investigator
Facility:
Name:
ICANS - Institut de cancérologie Strasbourg
Address:
City:
Strasbourg
Country:
France
Status:
Recruiting
Contact:
Last name:
Philippe Barthelemy, MD, PhD
Start date:
October 1, 2022
Completion date:
June 2026
Lead sponsor:
Agency:
EverImmune
Agency class:
Industry
Source:
EverImmune
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05865730
