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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Hopital Ambroise Pare	Boulogne-Billancourt	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Axwrvsagth Plvysoov Hdazyjhy Dz Pivrd	Paris	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	18.03.2022

Trial locations

Investigated drugs:

Allogeneic Faecal Microbiota, Pooled

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.

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 ID:

2024-516100-42-00

Protocol code:

APHP200133

NCT ID:

NCT04988841

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?