Recruiting

Akkermansia Muciniphila Supplementation for Improved Immunotherapy Efficacy in NSCLC or RCC Patients

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What is being tested

Live Bacterial Product - Akkermansia muciniphila

Other
Who is being recruted

Urogenital Diseases+21

+ Adenocarcinoma

+ Bronchial Neoplasms

Over 18 Years
+20 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2022
See protocol details

Summary

Principal SponsorEverImmune
Study ContactAlain Thibault, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2022

Actual date on which the first participant was enrolled.

This study focuses on a bacterium called Akkermansia muciniphila, which naturally exists in the healthy human gut. Research shows that the presence of this bacterium in patients with Non-Small Cell Lung Cancer (NSCLC) or Renal Cell Carcinoma (RCC) is linked with the effectiveness of immunotherapy. The study aims to explore if giving a specific strain of this bacterium, Oncobax®-AK, to cancer patients undergoing immunotherapy can improve the treatment's efficacy, particularly for those with NSCLC or RCC who lack sufficient amounts of Akkermansia in their gut. Participants in this study will orally take Oncobax®-AK. The study's primary goal is to measure the Objective Response Rate, which indicates how well the treatment shrinks the tumor. This will be evaluated using a specific set of criteria called iRECIST. The study hopes to determine if Oncobax®-AK can enhance the response to immunotherapy in patients with NSCLC or RCC.

Official TitleA Phase 1/2 Study of Oncobax®-AK Administered in Combination With Immunotherapy To Patients With Advanced Solid Tumors
NCT05865730
Principal SponsorEverImmune
Study ContactAlain Thibault, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

122 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesAdenocarcinomaBronchial NeoplasmsCarcinomaCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungCarcinoma, Renal CellFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesKidney NeoplasmsLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

10 inclusion criteria required to participate
Histologically confirmed Stage IV non-squamous NSCLC or clear cell RCC
NSCLC-specific criterion: Best tumor response (by iRECIST) as Stable Disease
Age > 18 years
ECOG Performance Status = 0-1
Show More Criteria
10 exclusion criteria prevent from participating
Inability to comply with protocol-specific assessments
Immunosuppressive therapy (> 10 mg prednisone/day equivalent)
Calculated creatinine clearance < 45 ml/min
Auto-immune diseases requiring systemic therapy
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Oncobax-AK (1 capsule) will be administered daily until PD\< excessive toxicity or withdrawal of consent

Group II

Experimental
Oncobax-AK (1 capsule) will be administered daily until PD\< excessive toxicity or withdrawal of consent

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Recruiting

CHU Ambroise Paré

Mons, BelgiumOpen CHU Ambroise Paré in Google Maps
Recruiting

Centre Georges Francois Leclerc

Dijon, France
Recruiting

Institut Gustave Roussy

Paris, France
Recruiting

ICANS - Institut de cancérologie Strasbourg

Strasbourg, France
Recruiting
4 Study Centers