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Study of Oncobax-AK with Immunotherapy for Patients with Advanced Non-Small Cell Lung Cancer or Renal Cell Carcinoma

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying advanced solid tumors, specifically Non-Small Cell Lung Cancer (NSCLC) and Renal Cell Carcinoma (RCC). The study involves a treatment called Oncobax®-AK, which is a capsule containing live bacteria known as Akkermansia muciniphila, strain P2261. This treatment will be used in combination with various immunotherapy drugs, including YERVOY (ipilimumab), Tecentriq (atezolizumab), KEYTRUDA (pembrolizumab), OPDIVO (nivolumab), and LIBTAYO (cemiplimab). These drugs are administered through an intravenous infusion, which means they are given directly into a vein.

The purpose of this study is to evaluate the safety and effectiveness of Oncobax®-AK when used alongside these immunotherapy treatments. The study is divided into two phases. In the first phase, the focus is on understanding how safe and tolerable the combination of Oncobax®-AK and immunotherapy is for patients with metastatic NSCLC or RCC who have low levels of Akkermansia bacteria. The second phase aims to assess how well this combination works in treating these cancers.

Participants in the study will receive repeated doses of Oncobax®-AK along with their immunotherapy treatment. The study will monitor the patients' response to the treatment and any side effects they may experience. The goal is to gather information that could help improve treatment options for patients with advanced NSCLC and RCC. This study is expected to continue until September 2025.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as confirmed diagnosis of advanced solid tumors, including non-small cell lung cancer (NSCLC) or renal cell carcinoma (RCC).

    Initial assessments include blood tests to ensure adequate levels of hemoglobin, neutrophils, platelets, lymphocytes, and albumin.

    A negative stool test for specific bacteria is required, and a commitment to use effective birth control methods is necessary for patients of child-bearing potential.

  2. Step 2

    Phase 1 treatment

    The first phase focuses on evaluating the safety and tolerability of the treatment.

    The treatment involves the administration of Oncobax®-AK in combination with PD-L1-based immunotherapy.

    Medications such as ipilimumab, atezolizumab, pembrolizumab, nivolumab, and cemiplimab are administered intravenously.

    The specific dosage and frequency depend on the individual treatment plan and response.

  3. Step 3

    Phase 2 treatment

    The second phase aims to assess the effectiveness of the treatment.

    Continued administration of Oncobax®-AK with PD-L1-based immunotherapy is conducted.

    The focus is on measuring the response of the tumors to the treatment and monitoring any side effects.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, regular monitoring of health status and tumor response is conducted.

    Assessments include imaging tests and laboratory evaluations to track progress and detect any adverse effects.

    The study is expected to continue until September 2025, with ongoing evaluations to ensure safety and effectiveness.

Who can join the trial?

17 criteria

  • Must have a confirmed diagnosis of **Stage IV Non-Small Cell Lung Cancer (NSCLC)** or **clear cell Renal Cell Carcinoma (RCC)**. This means the cancer is advanced and has spread to other parts of the body.
  • Hemoglobin level must be **90 g/L** or higher. Hemoglobin is a protein in red blood cells that carries oxygen.
  • Neutrophil count must be **1.0 x 109/L** or higher. Neutrophils are a type of white blood cell important for fighting infections.
  • Platelet count must be **75 x 109/L** or higher. Platelets help with blood clotting.
  • Lymphocyte count must be more than **0.5 x 109/L**. Lymphocytes are a type of white blood cell important for the immune system.
  • Albumin level must be more than **30 g/L**. Albumin is a protein in the blood that helps maintain fluid balance.
  • Must have a **wash-out period** of 5 half-lives or more since the last dose of any investigational drugs or chemotherapy. This means enough time has passed since the last treatment to ensure it is out of the body.
  • If of child-bearing potential, must agree to use a **birth control method** with a failure rate of less than 1% per year during treatment and for at least 4 months after the last dose for NSCLC patients or 5 months for RCC patients.
  • Must sign an **informed consent form**, agreeing to participate in the study after understanding the details and risks.
  • Must be eligible for **standard care PD-L1 based immunotherapy** or chemo-immunotherapy for NSCLC, and ipilimumab + nivolumab for RCC.
  • For NSCLC patients, must have a **stable disease** response between 12 and 18 weeks after starting first-line PD-L1-based treatment.
  • For RCC patients, must be newly diagnosed with **intermediate- or poor-risk** clear cell RCC.
  • Must have a **negative stool test** for Akkermansia, a type of bacteria, as specified in the study protocol.
  • For NSCLC patients, must have **PD-L1 expression** data of 1% or higher. PD-L1 is a protein that can affect how the immune system responds to cancer.
  • Must have at least one **measurable lesion** according to specific criteria. A lesion is an area of abnormal tissue.
  • Must have an **ECOG performance status** of 0-1, indicating the patient is fully active or has some symptoms but can carry out light work.
  • Must be **over 18 years old**.

Who cannot join the trial?

6 criteria

  • Patients who are not diagnosed with Non-Small Cell Lung Cancer (NSCLC) or Renal Cell Carcinoma (RCC).
  • Patients who are not deficient in Akkermansia, a type of bacteria in the gut.
  • Patients who are not receiving PD-L1-based chemo-immunotherapy or immunotherapy. PD-L1 is a protein that helps cancer cells hide from the immune system, and immunotherapy is a treatment that helps the immune system fight cancer.
  • Patients who are not in the age range specified for the trial.
  • Patients who are not part of the clinical trial groups specified for the study.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Oncobax®-AK is a medication being studied for its potential to help treat advanced solid tumors. It is given to patients who have a deficiency in a specific type of bacteria called Akkermansia. The study is looking at how safe and tolerable this medication is when used repeatedly. It is combined with another type of treatment called PD-L1-based chemo-immunotherapy, which is used to help the body's immune system fight cancer. This combination is being tested in patients with certain types of cancer, specifically metastatic non-small cell lung cancer (NSCLC) or renal cell carcinoma (RCC).

What is already known about the treatment

Oncobax-AK – This medication is administered orally and is currently being studied in clinical trials for its use in combination with immunotherapy. It is in the investigational stage, with ongoing research to determine its safety and effectiveness. The main therapeutic indications for Oncobax-AK are advanced solid tumors, specifically non-small cell lung cancer (NSCLC) and renal cell carcinoma (RCC). At the molecular level, it is believed to work by enhancing the immune response against cancer cells, particularly in patients with a deficiency in a specific gut bacterium called Akkermansia. Oncobax-AK is classified as an immunomodulatory agent, aiming to improve the outcomes of existing cancer treatments.

Investigated diseases

  • Non-Small Cell Lung Cancer

    This is the most common type of lung cancer, accounting for about 85% of cases. It typically starts in the epithelial cells lining the lungs and can grow and spread to other parts of the body. The disease progresses through stages, beginning with localized tumors and potentially advancing to more widespread metastasis. Symptoms may include persistent cough, chest pain, and difficulty breathing. The progression can vary significantly between individuals, influenced by factors such as genetic mutations and environmental exposures.

  • Renal Cell Carcinoma

    This is the most common type of kidney cancer in adults, originating in the lining of the small tubes in the kidney. It often grows as a single tumor within a kidney, but sometimes multiple tumors can develop in one or both kidneys. As the disease progresses, it may spread to nearby lymph nodes and other organs, such as the lungs and bones. Symptoms can include blood in the urine, a lump in the abdomen, and unexplained weight loss. The rate of progression can differ based on the tumor's size, location, and genetic characteristics.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-516711-24-00Protocol codeEV-2101Estimated enrolment128 patientsSponsorEverimmune

sourced from the EU Clinical Trials Register and site verification

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