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Study of MaaT013 (Fecal Transplantation) Combined with Ipilimumab and Nivolumab in Patients with Previously Untreated Melanoma

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What is this trial about?

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

This study focuses on patients with melanoma, a type of skin cancer, who are receiving treatment with ipilimumab and nivolumab (medications that help the immune system fight cancer). The study tests a new treatment called MaaT013, which is a solution containing beneficial gut bacteria that is administered rectally, along with the standard cancer treatment.

The purpose of this research is to determine if using MaaT013 together with ipilimumab and nivolumab is safe and well-tolerated by patients with melanoma who have not previously received these cancer treatments. The study will compare patients who receive MaaT013 with those who receive a placebo in combination with their cancer medications.

The treatment period lasts 23 weeks, during which patients will receive either MaaT013 or placebo along with their regular cancer medications. Throughout the study, doctors will monitor patients' health and how their cancer responds to the treatment. The total observation period extends to 27 weeks to assess the overall effects of the treatment combination.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will begin treatment with a combination of two medications: ipilimumab and nivolumab (medications that help your immune system fight cancer cells)

    During this phase, you will be randomly assigned to receive either MaaT013 (an intestinal microbiota solution) or a placebo (an inactive substance) through rectal administration

  2. Step 2

    Treatment monitoring period - Week 1 to Week 27

    Your treatment and health status will be monitored for 27 weeks

    Regular assessments will include tumor measurements using imaging scans

    Blood tests will be performed to monitor your health status

    Samples will be collected to analyze changes in your intestinal microbiome

  3. Step 3

    Extended follow-up - Week 27 to Week 51

    Your health status will continue to be monitored through Week 51

    Additional tumor assessments will be performed at weeks 15, 27, and 51

    Your overall survival and disease progression status will be evaluated

  4. Step 4

    Safety monitoring

    Throughout the study, you will be monitored for any side effects or adverse reactions

    Any health-related events will be evaluated and categorized according to their severity

    Your tumor response to treatment will be measured using standardized criteria (RECIST)

  5. Step 5

    Additional assessments

    Analysis of changes in your immune system response

    Evaluation of proteins and metabolites in your blood

    Assessment of changes in your intestinal microbiome composition

Who can join the trial?

15 criteria

  • Age between 18 and 80 years
  • Must have unresectable or metastatic melanoma (skin cancer that cannot be surgically removed or has spread)
  • Must have measurable disease confirmed by scan or examination within 2 weeks before screening
  • Must have an ECOG performance status of 0-2 (a measure of daily living abilities)
  • Women who can become pregnant must use effective contraception during treatment and for 6 months after the last dose
  • Men with partners who can become pregnant must use contraception during treatment and for 7 months after the last dose
  • Must have adequate blood test results including:
    • Hemoglobin levels ≥9 g/dL (oxygen-carrying protein in blood)
    • Platelet count ≥100,000/mm3 (blood cells that help with clotting)
    • Neutrophil count ≥1,500/mm3 (type of white blood cells)
    • Must have adequate kidney function (Creatinine Clearance ≥50mL/min)
    • Must have adequate liver function tests
    • Must not have received previous treatment with ipilimumab and anti-PD1/PDL1 (unless used in adjuvant setting at least 6 months before)
    • Must be able to provide written informed consent
    • Must understand the risks associated with the study treatment
    • Must have a negative pregnancy test (for women)

Who cannot join the trial?

13 criteria

  • Prior treatment with ipilimumab (a type of immunotherapy drug) or anti-PD1 medications
  • Age below 18 years or above 75 years
  • Pregnancy or breastfeeding
  • History of autoimmune diseases (conditions where the immune system attacks healthy cells)
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • Serious heart conditions or uncontrolled high blood pressure
  • Active infections requiring systemic treatment (medications that affect the whole body)
  • Use of systemic corticosteroids (medications that suppress the immune system)
  • History of organ transplantation
  • Known HIV infection, active hepatitis B, or hepatitis C
  • Any other medical condition that could interfere with the study treatment or patient safety
  • Unable to provide informed consent
  • Participation in another clinical trial within the past 30 days
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Investigated drugs

  • MaaT013

    is a treatment derived from human fecal microbiota (gut bacteria). It is designed to help restore balance to the gut microbiome and potentially improve the effectiveness of cancer immunotherapy.

  • Ipilimumab

    is an immunotherapy medication that helps the immune system fight cancer cells. It works by blocking a protein called CTLA-4, which normally helps keep immune system responses in check.

  • Nivolumab

    is also an immunotherapy medication that helps the immune system fight cancer. It works by blocking a protein called PD-1, which can prevent the immune system from attacking cancer cells.

What is already known about the treatment

  • Ipilimumab

    An intravenously administered immunotherapy medication used in the treatment of advanced melanoma. This monoclonal antibody works by blocking CTLA-4, a protein that normally helps keep immune system T-cells in check, thereby enhancing the body's immune response against cancer cells. It belongs to the class of immune checkpoint inhibitors and is commonly used in combination therapy for melanoma treatment, showing significant effectiveness in clinical trials.

  • Nivolumab

    An immunotherapy drug administered through intravenous infusion that has become a standard treatment option for various types of cancer, including melanoma. This medication works by blocking the PD-1 protein on T-cells, which helps the immune system recognize and attack cancer cells more effectively. It belongs to the class of PD-1 inhibitors and is often used in combination with ipilimumab to enhance treatment outcomes in melanoma patients.

  • MaaT013

    A novel fecal microbiota transplant therapy administered orally that is being investigated for its potential to improve the effectiveness of cancer immunotherapy treatments. This biological preparation contains carefully selected gut microbiota that may help reduce side effects and enhance the therapeutic response to immune checkpoint inhibitors in melanoma patients. It represents an innovative approach in supportive cancer care, currently being evaluated in clinical trials.

Investigated diseases

Melanoma - A type of skin cancer that develops in melanocytes, the cells that produce melanin (skin pigment). It typically begins as a new, unusual-looking spot on the skin or develops from an existing mole that changes in appearance. The condition can appear anywhere on the body, including areas not regularly exposed to sunlight. Melanoma may show changes in color, size, or shape of skin spots, and these changes often occur asymmetrically. The affected area may also become itchy or develop other unusual sensations.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516100-42-00Protocol codeAPHP200133Estimated enrolment70 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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