Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Fecal Microbiota Transplant (FMT)

Placebo

Armin Rashidi, MD, PhD

This is a randomized, double-blind, placebo-controlled clinical trial of Fecal Microbiota Transplant (FMT) in 2 independent cohorts (60 acute myeloid leukemia patients undergoing intensive chemotherapy and 60 Allo-HCT patients). Participants in each cohort will be randomized in a 2:1 ratio to receive up to 3 treatments of FMT vs. placebo after each exposure to antibacterial antibiotics until 3 months after randomization.

A Study of FMT in Patients With AML Allo HSCT in Recipients

A Randomized Placebo-Controlled Clinical Trial of Fecal Microbiota Transplantation in Patients With Acute Myeloid Leukemia and Allogeneic Hematopoietic Cell Transplantation Recipients

Number of infections infections until 4 months after the first intervention. Monitored each visit through safety assessment.

Proportion of Donor Microbiome Fecal Microbiota Transplantation (FMT) Present in Transplant Recipient. Patient and donor samples analyzed with SourceTracker software.

Percentage of Participants with Grade II-IV Acute Graft-versus-host Disease (aGVHD II-IV). Monitored each visit through safety assessment. Grade II better, Grade IV worse.

Number of BSI of suspected gut origin. Monitored each visit through safety assessment.

Number of Bacterial Infections. Monitored each visit through safety assessment.

Number of Viral Infections. Monitored each visit through safety assessment.

Number of Fungal Infections. Monitored each visit through safety assessment.

Masonic Cancer Center, University of Minnesota

Fecal Microbiota Transplant (FMT): Oral Capsule

AML Patients Undergoing Intensive Chemotherapy

AML Patients Undergoing Intensive Chemotherapy Control

Patients Undergoing Allo-HCT

Patients Undergoing Allo-HCT Control

AML Patients Undergoing Intensive Chemothera

Patients Undergoing Allo-HCT Patients

Patients Undergoing Allo-HCT Patients Control

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Efficacy of FMT in AML Patients and Allo-HCT Recipients - Number of Infections

Only a subset of patients were evaluable for engraftment analysis. This is because they either didn't provide a sample or their sample didn't meet the quality criteria.

FMT Engraftment

Experimental: Patients Undergoing Allo-HCT

Placebo Comparator: Patients Undergoing Allo-HCT Control

Percentage of Participants With Grade II-IV Acute Graft-versus-host Disease (aGVHD II-IV)

Number of BSI of Suspected Gut Origin

Number of Bacterial Infections

Number of Viral Infections

Number of Fungal Infections

Overall Study

Skin and Connective Tissue Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Pharmaceutical Solutions

All Drugs and Chemicals

Immunomodulating Agents

FMT includes a colonoscopy conducted by a gastroenterologist followed by stool capsules which will be swallowed by the patient.

Patients with metastatic melanoma who responded to immunotherapy will serve as the fecal implant donors. The tested fecal implant will be used for two different products. The first part of the tested stool will be mixed with a saline solution, strained and infused into your bowel using colonoscopy. The second part of the tested stool will be packed into capsules. These stool capsules are at the size of standard drug-containing capsules and can be swallowed in a standard manner. Stool capsules are a common method of FMT and has been used worldwide for several years. After the colonoscopy, you will be asked to swallow the capsules. Swallowing the capsules will be conducted at the clinic, and does not require any additional procedures.

Gal N Markel, MD,PhD

Ben S Boursi, MD

Erez N Baruch, MD

Gal Markel, MD, PhD

Altering the Gut Microbiota of Melanoma Patients Who Failed Immunotherapy Using Fecal Microbiota Transplantation (FMT) From Responding Patients.

FMT includes both colonoscopy and stool capsules.

This is a phase I single-center study of fecal microbiota transplant (FMT) in melanoma patients who failed at least one line of PD-1 blockade.

Eligible patients must have a disease amenable to biopsy and lack of contra-indications to FMT.

Patients will undergo a baseline evaluation including imaging, tumor biopsy, blood samples and stool studies to confirm suitability for the study.

Eligible patients will undergo FMT. The FMT includes a colonoscopy followed by stool capsules.

Patients will undergo repeated evaluations including follow-up blood, stool and radiological testings.

The study will be conducted over a 24-week period.

Fecal Microbiota Transplantation (FMT) in Metastatic Melanoma Patients Who Failed Immunotherapy

Altering the Gut Microbiota of Melanoma Patients Who Failed Immunotherapy Using Fecal Microbiota Transplantation (FMT) From Responding Patients

Number of patients with objective responses divided by the total number of evaluable patients, according to imaging studies (RECIST 1.1) and iRECIST.

Number of patients with adverse events that emerged post FMT

Comparing of the patients' gut bacterial composition pre and post-FMT and in relation to their donors. Bacterial composition will be quantified by the operational taxonomic unit (OTU) in the stool

Changes in the relative abundance of different immune cell population (such as the proportion of CD8+ T cells) pre and post-FMT.

Changes in levels of proteins that represent immune activity against cancer (such as measurements of blood interferon gamma levels), pre and post FMT

Sheba Medical Center

Chief Scientist of The Ella Lemelbaum Institute of Immuno-Oncology, Principal Investigator, Associate Professor of Immunology

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

Herbal and Botanical

Pembrolizumab

Nivolumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Cola

The FMT along with an intestinal biopsy will be performed as outpatient by a gastroenterologist. The FMT is infused into the colon by performing a colonoscopy (Treatment Phase 1) and by a sigmoidoscopy (Treatment Phase 2). FMT will be performed on Cycle 1 Day 1 and Cycle 3 Day 1 during Treatment Phase 1 and every 9 weeks starting with Cycle 4 Day 1 during Treatment Phase 2.

Pembrolizumab, 200mg, will be administered as a 30-minute IV infusion every 3 weeks starting Cycle 1 Day 1 (same day as the FMT), and continue on Day 1 of each 21-day cycle.

FMT is a procedure in which fecal matter or stool is collected from a tested donor, mixed with a saline or other solution, strained and infused into the colon by performing a colonoscopy and sigmoidoscopy. The FMT consists of introducing normal bacterial flora contained in the stool collected from a donor into the small intestine. In this case, the donors are patients with advanced metastatic non-small cell lung cancer (NSCLC) who have undergone PD-1 therapy (nivolumab or pembrolizumab) and are currently in a durable remission that is ongoing. The FMT will be performed on Cycle 1 Day 1 and Cycle 3 Day 1 during Treatment Phase 1 and every 9 weeks starting with Cycle 4 Day 1 during Treatment Phase 2.

Pembrolizumab, 200mg, will be administered as a 30-minute IV infusion every 3 weeks starting Cycle 1 Day 1 (same day as the FMT), and continue on Day 1 of each 21-day cycle.

Amy Rose, RN, BSN

Diwakar Davar, MD, PhD

Diwakar Davar, MD

This study is to determine if a fecal microbiota transplant (FMT) improves the body's ability to fight cancer in patients with relapsed/refractory PD-L1 Positive NSCLC.

The study evaluating the addition of R-FMT to pembrolizumab in PD-1 R/R NSCLC will be conducted over a 104-week period. Patients with anti-PD-1 R/R NSCLC are eligible to enroll. Prior exposure to microbiome modulating therapy is exclusionary. Suitable patients will be identified at the time of progression upon PD-1 monotherapy or PD-1 containing regimens. Patients will undergo a 35-day screening evaluation consisting of systemic staging scans, tumor biopsy, stool/blood serologic studies to confirm suitability.

Once enrolled, patients will be seromatched with a suitable donor. Suitable donors are advanced cancer patients who have undergone PD-1 monotherapy and are currently in durable remission (median PFS \>24 months from initiation of PD-1 therapy) with no ongoing irAE as delineated below. Patients will receive R-FMT (induction) via colonoscopy on C1D1 and C3D1. R-FMT (maintenance) via sigmoidoscopy on C4D1 and will be repeated every 9 weeks. All patients will additionally receive pembrolizumab at 200mg every three weeks. Patients will be treated until disease progression or intolerable toxicity or completion of 2 years of therapy, whichever comes first.

Responder-derived FMT (R-FMT) and Pembrolizumab in Relapsed/Refractory PD-L1 Positive NSCLC

Phase II Feasibility Study of Responder-derived FMT (R-FMT) and Pembrolizumab in Relapsed/Refractory PD-L1 Positive NSCLC

The proportion of patients with objective response (Complete Response (CR) or Partial Response (PR)) to R-FMT and pembrolizumab treatment in PD-1 primary refractory NSCLC as assessed per RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. For non-target lesions: Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10mm short axis); PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Frequency of Adverse Events and specifically ≥grade 2 irAEs per CTCAE v5.0 in PD-1 primary refractory NSCLC in patients treated with R-FMT and pembrolizumab, to assess overall safety, feasibility and tolerability of treatment.

The proportion of patients Complete Response (irCR) or Partial Response (irPR) to treatment as assessed per iRECIST. irCR:Disappearance of non-nodal lesions.All pathologic lymph nodes \<10 mm (short axis) (2 consecutive measurements ≥4 weeks apart); irPR :≥30% decrease from baseline (2 consecutive measurements ≥4 weeks apart). Disappearance of all non-nodal lesions.All pathologic lymph nodes \<10 mm (Non-Target Lesions:Any other than disappearance of all non-nodal lesions and reduction of pathologic lymph nodes \<10 mm). Baseline tumor burden: sum of single diameters (short axis for nodal lesions, longest diameter for other lesions) for target lesions. In subsequent scans, the diameters of new measurable lesions are added to the tumor burden. Re-treatment: ≤5 target lesions (=/≠ original lesions) are selected and a new baseline tumor burden will be established. (no distinct iRECIST assessment until radiographic progression per RECIST 1.1 is observed).

Percentage of CD8+ T cells in intra-tumoral myeloid cells in pre-treatment biopsy samples assess using multiplex IHC.

The median length of time from initiation of study drug(s) disease progression as defined by RECIST v1.1, or death. Progressive Disease (PD): ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.

The median length of time that patients remain alive after treatment.

Percentage of patients without disease progression at 6 months after start of treatment, per RECIST v1.1. Progressive Disease (PD): ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.

Percentage of patients without disease progression at 1 year after start of treatment, per RECIST v1.1. Progressive Disease (PD): ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.

Percentage of patients without disease progression at 2 years after start of treatment, per RECIST v1.1. Progressive Disease (PD): ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.

Percentage of patients that are alive at 1 year after start of treatment.

Percentage of patients that are alive at 2 years after start of treatment.

Gateway for Cancer Research

Diwakar Davar

Assistant Professor of Medicine - Hematology, Oncology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma, Squamous Cell

Carcinoma, Renal Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms, Squamous Cell

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Head and Neck Neoplasms

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Jon Amund Kyte, MD, Ph.D.

Andreas Ullern, MD

Jon Amund Kyte, MD Ph.D.

This is a single-arm, single-center, open-label, phase IIa study evaluating the safety, feasibility and efficacy of Faecal Microbiota Transplant (FMT) to cancer patients not responding to ICI therapy, using ICI-responders as donors.

Immunotherapy with immune checkpoint inhibitors (ICI) has shown remarkable clinical efficacy against several cancer forms. This includes durable responses in patients with metastatic cancers and no other effective treatment options. However, many patients do not respond. This leaves a major challenge; how to turn non-responders into responders. Herein, this challenge is addressed, by attempting to modulate patients' intestinal microbiota through Faecal Microbiota Transplant (FMT). Data from several preclinical and translational studies have indicated that the microbiota composition is important for the effect of ICIs. Moreover, two recent trials exploring FMT for melanoma patients have suggested acceptable safety and a potential clinical benefit.

Microbiota Transplant to Cancer Patients Who Have Failed Immunotherapy Using Faeces From Clinical Responders

MITRIC: Microbiota Transplant to Cancer Patients Who Have Failed Immunotherapy Using Faeces From Clincal Responders

Immunological changes in blood (PBMC, serum/plasma), gut and tumor tissue

Microbial gut composition, tumor tissue, blood and gut will be characterized and correlated with treatment outcome. Assessment will include baseline profile and changes after FMT

T cell receptor binding and T cell reactivity to selected peptides

Comparison of tumor biopsies at baseline and later time points, by gene and protein profiling

Safety of the intervention (FMT) as assessed by the incidence, nature, and severity of Adverse Events (AE) according to NCI CTCAE, version 5.0

Objective Tumor Response Rate (ORR) as assessed by iRECIST in FAS

The percentage of included patients that receive i) at least two FMT, ii) the scheduled number of FMT until End of Intervention (EOI)

Comparison of the patients' gut bacterial composition before and after FMT and in relation to their donors

Patient reported outcomes (PRO) as assessed by EORTC quality of life questionnaire (QLQ-C30)

Patient reported outcomes (PRO) as assessed by Chalder Fatigue Questionnaire (FQ)

Patient reported outcomes (PRO) as assessed by an 11-point Numerical Rating Scale (NRS) for pain intensity

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of FMT in Patients With AML Allo HSCT in Recipients	NCT03678493	Acute Myeloid L... Allogeneic Hema...	Fecal Microbiot... Placebo	18 Years -	Masonic Cancer Center, University of Minnesota
Fecal Microbiota Transplantation (FMT) in Metastatic Melanoma Patients Who Failed Immunotherapy	NCT03353402	Melanoma Stage ... Unresectable St...	Fecal Microbiot...	18 Years -	Sheba Medical Center
Responder-derived FMT (R-FMT) and Pembrolizumab in Relapsed/Refractory PD-L1 Positive NSCLC	NCT05669846	Non Small Cell ...	Fecal Microbiot... Pembrolizumab	18 Years -	University of Pittsburgh
Responder-derived FMT (R-FMT) and Pembrolizumab in Relapsed/Refractory PD-L1 Positive NSCLC	NCT05669846	Non Small Cell ...	Fecal Microbiot... Pembrolizumab	18 Years -	University of Pittsburgh
Responder-derived FMT (R-FMT) and Pembrolizumab in Relapsed/Refractory PD-L1 Positive NSCLC	NCT05669846	Non Small Cell ...	Fecal Microbiot... Pembrolizumab	18 Years -	University of Pittsburgh
Microbiota Transplant to Cancer Patients Who Have Failed Immunotherapy Using Faeces From Clinical Responders	NCT05286294	Melanoma Stage ... Head and Neck S... Cutaneous Squam... MSI-High Clear Cell Rena... Non-small Cell ...	Fecal Microbiot...	18 Years -	Oslo University Hospital

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