Carcinoma, Renal CellPhase 2NCT05865730
A Study of Oncobax®-AK in Patients With Advanced Solid Tumors
A Phase 2 study testing Live Bacterial Product - Akkermansia muciniphila in people with Carcinoma, Renal Cell and Carcinoma, Non-Small-Cell Lung, run by EverImmune at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Live Bacterial Product - Akkermansia muciniphila
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Oct 2022to Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Histologically confirmed Stage IV non-squamous NSCLC or clear cell RCC
- NSCLC-specific criterion: Best tumor response (by iRECIST) as Stable Disease
- NSCLC-specific criterion: PD-L1 expression > 50%
- ECOG Performance Status = 0-1
- Negative stool PCR test for Akkermansia
Show all 10Show fewer
- At least one measurable lesion per iRECIST
- Hemoglobin ≥ 100 g/L
- Albumin > 35 g/L
- Signed informed consent
Who cannot join
- Symptomatic brain metastases
- AST or ALT > 5 x ULN
- Calculated creatinine clearance < 45 ml/min
- Auto-immune diseases requiring systemic therapy
- Immunosuppressive therapy (> 10 mg prednisone/day equivalent)
- Radiotherapy (> 30 Gy) to the lung(s) within 6 months of signed informed consent
Show all 10Show fewer
- Active infection
- Co-morbidities that may increase the risk of treatment-related adverse events
- Pregnancy
- Inability to comply with protocol-specific assessments
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
France3 sites, 3 recruiting
- Recruiting
Centre Georges Francois Leclerc
Dijon
Francois Ghiringhelli, MD, PhD
- Recruiting
Institut Gustave Roussy
Paris
Laurence Albiges, MD, PhD
Lisa Derosa, Md, PhD
- Recruiting
ICANS - Institut de cancérologie Strasbourg
Strasbourg
Philippe Barthelemy, MD, PhD
Belgium1 site, 1 recruiting
- Recruiting
CHU Ambroise Paré
Mons
Stephane Holbrechts, MD
About this study
Official title: A Phase 1/2 Study of Oncobax®-AK Administered in Combination With Immunotherapy To Patients With Advanced Solid Tumors
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.
- Being tested
- Live Bacterial Product - Akkermansia muciniphila
- Medical subject headings
- Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Bacterial Product - Akkermansia muciniphilaOther
Oral administration of Oncobax-AK to patients deficient in Akkermansia by stool metagenomic analysis.
| Study group | Role | What they receive |
|---|---|---|
| Phase 2 - NSCLC | Experimental | Oncobax-AK (1 capsule) will be administered daily until PD< excessive toxicity or withdrawal of consent Receives: Other: Live Bacterial Product - Akkermansia muciniphila |
| Phase 2 -RCC | Experimental | Oncobax-AK (1 capsule) will be administered daily until PD< excessive toxicity or withdrawal of consent Receives: Other: Live Bacterial Product - Akkermansia muciniphila |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
iRECIST
Measured: 9 months
Secondary outcomes (1)
Progression-free survival
iRECIST
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start1 Oct 2022
- Primary completionJun 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 1 cohort of patients with NSCLC recruited in parallel to 1 cohort recruiting RCC patients.
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EverImmune
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fabrice Barlesi, MD, PhD, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865730
- Sponsor's protocol ID
- EV-2101
- Status last verified
- May 2023
- First submitted
- 20 Mar 2023
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Derosa L, Routy B, Thomas AM, Iebba V, Zalcman G, Friard S, Mazieres J, Audigier-Valette C, Moro-Sibilot D, Goldwasser F, Silva CAC, Terrisse S, Bonvalet M, Scherpereel A, Pegliasco H, Richard C, Ghiringhelli F, Elkrief A, Desilets A, Blanc-Durand F, Cumbo F, Blanco A, Boidot R, Chevrier S, Daillere R, Kroemer G, Alla L, Pons N, Le Chatelier E, Galleron N, Roume H, Dubuisson A, Bouchard N, Messaoudene M, Drubay D, Deutsch E, Barlesi F, Planchard D, Segata N, Martinez S, Zitvogel L, Soria JC, Besse B. Intestinal Akkermansia muciniphila predicts clinical response to PD-1 blockade in patients with advanced non-small-cell lung cancer. Nat Med. 2022 Feb;28(2):315-324. doi: 10.1038/s41591-021-01655-5. Epub 2022 Feb 3.
PubMed 35115705Derosa L, Routy B, Fidelle M, Iebba V, Alla L, Pasolli E, Segata N, Desnoyer A, Pietrantonio F, Ferrere G, Fahrner JE, Le Chatellier E, Pons N, Galleron N, Roume H, Duong CPM, Mondragon L, Iribarren K, Bonvalet M, Terrisse S, Rauber C, Goubet AG, Daillere R, Lemaitre F, Reni A, Casu B, Alou MT, Alves Costa Silva C, Raoult D, Fizazi K, Escudier B, Kroemer G, Albiges L, Zitvogel L. Gut Bacteria Composition Drives Primary Resistance to Cancer Immunotherapy in Renal Cell Carcinoma Patients. Eur Urol. 2020 Aug;78(2):195-206. doi: 10.1016/j.eururo.2020.04.044. Epub 2020 May 4.
PubMed 32376136
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of Oncobax®-AK Administered in Combination With Immunotherapy To Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05865730
- Acronym / sponsor ID
- EV-2101
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- EverImmuneIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1 cohort of patients with NSCLC recruited in parallel to 1 cohort recruiting RCC patients.
| Arm | Type | Receives |
|---|---|---|
| Phase 2 - NSCLC | Experimental | Other: Live Bacterial Product - Akkermansia muciniphilaOncobax-AK (1 capsule) will be administered daily until PD< excessive toxicity or withdrawal of consent |
| Phase 2 -RCC | Experimental | Other: Live Bacterial Product - Akkermansia muciniphilaOncobax-AK (1 capsule) will be administered daily until PD< excessive toxicity or withdrawal of consent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age > 18 years
- Histologically confirmed Stage IV non-squamous NSCLC or clear cell RCC
- NSCLC-specific criterion: Best tumor response (by iRECIST) as Stable Disease
- NSCLC-specific criterion: PD-L1 expression > 50%
- ECOG Performance Status = 0-1
Key exclusion criteria (10 listed)
- Symptomatic brain metastases
- AST or ALT > 5 x ULN
- Calculated creatinine clearance < 45 ml/min
- Auto-immune diseases requiring systemic therapy
- Immunosuppressive therapy (> 10 mg prednisone/day equivalent)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Live Bacterial Product - Akkermansia muciniphilaOral administration of Oncobax-AK to patients deficient in Akkermansia by stool metagenomic analysis. | Other | Phase 2 - NSCLC, Phase 2 -RCC |
Primary outcome
Objective Response Rate
Time frame: 9 months
iRECIST
1 secondary outcome
Progression-free survival
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Background: PubMed 35115705Derosa L, Routy B, Thomas AM, Iebba V, Zalcman G, Friard S, Mazieres J, Audigier-Valette C, Moro-Sibilot D, Goldwasser F, Silva CAC, Terrisse S, Bonvalet M, Scherpereel A, Pegliasco H, Richard C, Ghiringhelli F, Elkrief A, Desilets A, Blanc-Durand F, Cumbo F, Blanco A, Boidot R, Chevrier S, Daillere R, Kroemer G, Alla L, Pons N, Le Chatelier E, Galleron N, Roume H, Dubuisson A, Bouchard N, Messaoudene M, Drubay D, Deutsch E, Barlesi F, Planchard D, Segata N, Martinez S, Zitvogel L, Soria JC, Besse B. Intestinal Akkermansia muciniphila predicts clinical response to PD-1 blockade in patients with advanced non-small-cell lung cancer. Nat Med. 2022 Feb;28(2):315-324. doi: 10.1038/s41591-021-01655-5. Epub 2022 Feb 3.
- Background: PubMed 32376136Derosa L, Routy B, Fidelle M, Iebba V, Alla L, Pasolli E, Segata N, Desnoyer A, Pietrantonio F, Ferrere G, Fahrner JE, Le Chatellier E, Pons N, Galleron N, Roume H, Duong CPM, Mondragon L, Iribarren K, Bonvalet M, Terrisse S, Rauber C, Goubet AG, Daillere R, Lemaitre F, Reni A, Casu B, Alou MT, Alves Costa Silva C, Raoult D, Fizazi K, Escudier B, Kroemer G, Albiges L, Zitvogel L. Gut Bacteria Composition Drives Primary Resistance to Cancer Immunotherapy in Renal Cell Carcinoma Patients. Eur Urol. 2020 Aug;78(2):195-206. doi: 10.1016/j.eururo.2020.04.044. Epub 2020 May 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice Barlesi, MD, PhD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Live Bacterial Product - Akkermansia muciniphila in people with Carcinoma, Renal Cell and Carcinoma, Non-Small-Cell Lung, run by EverImmune at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alain Thibault, MD (+32472196345, alain.thibault@everimmune.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05865730, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.