Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Allogenic FMT group: patients receiving stool from prior malignant melanoma (MM) patients in remission for at least 1 year after Checkpoint Inhibitor Treatment.

Autologous FMT group: patients receiving their own stool in terms of sham FMT.

Patients receiving stool from prior malignant melanoma (MM) patients in remission for at least 1 year after Checkpoint Inhibitor Treatment.

Allogenic Fecal Microbiota Transplantation

Patients receiving their own stool in terms of sham FMT.

Autologous Fecal Microbiota Transplantation

Aim of the study is to investigate the effect of Fecal Microbiota Transplantation (FMT) and Checkpoint Inhibitor (CI) re-challenge in prior CI refractory patients on Progression free survival (PFS) and tumor using donor stool of former malignant melanoma patients, who have been in remission due to CI treatment for at least 1 year.

The IRMI-FMT Trial

INDUCING REMISSION IN MELANOMA PATIENTS WITH CHECKPOINT INHIBITOR THERAPY USING FECAL MICROBIOTA TRANSPLANTATION.

Patients undergoing CI therapy after FMT will be evaluated by Immune-RECIST (iRECIST) criteria after contrast-enhanced CT-scan in order to determine disease progression.

Complete response (CR), partial response (PR) and stable disease (SD) of target or non-target lesions are considered tumor response in this trial according to iRECIST criteria after three months.

A total of five donors will be included in the study. The allogenic-FMT group will receive donor stool from a single donor per patient for both, the primary FMT and a scheduled booster FMT. Donors will be divided into those, who successfully improved PFS and/or tumor response versus those, who were not able to induce treatment response. Donor stool will be evaluated by 16s-RNA analysis.

Patients will be divided into responders and nonresponders and microbiota will be analyzed via 16s-RNA analysis before and after FMT. We will look into specific donor-signaling in patients stool samples after FMT, as well as trying to identify groups of intestinal microbiota associated with higher response rates to CI re-challenge.

To evaluate safety and toxicity of CI therapy after FMT vs. control group. Drug toxicity will be monitored, categorized according to the CTCAE grading system Version 4.0 and managed according to recent recommendations by the SITC Toxicity Management Working Group.

In our study we will look at potential alterations in NLR after FMT and whether this can indicate response to CI treatment after FMT.

To date and according to present data we do not know, whether primary or secondary non-responders may have a better potential to respond to FMT in order to reach PFS under CI rechallenge. Hence, a subgroup analysis will be performed, in order to identify patient groups best suited for such treatment in the future.

Bristol-Myers Squibb

Medical University of Graz

Blood and Lymph Conditions

Symptoms and General Pathology

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Dysbiosis

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Patients will receive autologous fecal microbiota transplantation (MaaT011- 150 mL rectal enema) - 2 administrations 24 hours apart.

Mohamad Mohty, MD, PhD

The investigators propose to use autologous fecal microbiota transplantation (AFMT) to acute myeloid leukemia (AML) patients treated with intensive chemotherapy and antibiotics in order to restore the balance of their intestinal microbiome and thereby eradicate treatment-induced multidrug resistant bacteria (MDRB), infection-related complications, as well as sequelae to the gastrointestinal tract. Therefore, the investigators propose to perform a single-arm multicentre prospective fecal microbiota transplantation (FMT) trial in AML patients receiving intensive chemotherapy, and who are usually heavily treated with broad-spectrum antibiotics during aplasia that generate a profound status of dysbiosis. For this purpose, at the time of admission and AML diagnosis, patients will be requested to donate stools that will be comprehensively screened, and if deemed appropriate according to protocol criteria, conditioned and stored frozen until future processing and transplantation after aplasia completion.

PreventiOn of DYSbioSis Complications With Autologous FMT in AML Patients

PreventiOn of DYSbioSis Complications With Autologous Fecal Microbiota Transplantation in acutE myEloid Leukemia Patients Undergoing Intensive Treatment: A Feasibility and Safety Study ODYSSEE STUDY

Comparison of Alpha and Beta diversity indexes at baseline, after chemotherapy and after AFMT will be performed

MDRB carriage and resistome will be compared at baseline, after chemotherapy and after AFMT

Microbiota sequencing results will be correlated with immune parameters

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The IRMI-FMT Trial	NCT04577729	Fecal Microbiot... Malignant Melan... Malignant Melan...	Allogenic Fecal... Autologous Feca...	18 Years -	Medical University of Graz
PreventiOn of DYSbioSis Complications With Autologous FMT in AML Patients	NCT02928523	Leukemia, Myelo...	Autologous Feca...	18 Years - 65 Years	MaaT Pharma
The IRMI-FMT Trial	NCT04577729	Fecal Microbiot... Malignant Melan... Malignant Melan...	Allogenic Fecal... Autologous Feca...	18 Years -	Medical University of Graz
PreventiOn of DYSbioSis Complications With Autologous FMT in AML Patients	NCT02928523	Leukemia, Myelo...	Autologous Feca...	18 Years - 65 Years	MaaT Pharma

Spots Global Cancer Trial Database for autologous fecal microbiota transplantation