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

NCT03353402 | Unknown Phase 1 DMC

• 1 other identifier: SHEBA-17-3956-GM-CTIL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Melanoma Stage Iv; Unresectable Stage III Melanoma

Keywords

Melanoma; Fecal Microbiota Transplantation; Immunotherapy

Outcome Measures

Primary Outcomes (2)

• Incidence of FMT-related Adverse Events

  Number of patients with adverse events that emerged post FMT

  4 years

• Proper implant engraftment

  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

  4 years

Secondary Outcomes (2)

• Changes in composition of immune cell population

  4 years

• Changes in activity of immune cells

  4 years

Other Outcomes (1)

• Objective Response Rate (ORR)

  4 years

Study Arms (1)

Fecal Microbiota Transplant (FMT)

EXPERIMENTAL

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

Procedure: Fecal Microbiota Transplant (FMT)

Interventions

Fecal Microbiota Transplant (FMT) PROCEDURE

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.

Fecal Microbiota Transplant (FMT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A histologically confirmed diagnosis of metastatic melanoma.
• Failed at least one line of PD-1 blockade.
• ECOG Performance Status 0-2
• Able to provide written informed consent.

You may not qualify if:

• Presence of absolute contra-indications to FMT administration.
• Severe dietary allergies (e.g. shellfish, nuts, seafood).
• Anatomic contra-indications to colonoscopy.
• Inability to swallow capsules.
• Current participation in a study of an investigational agent.
• Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (\> 10 mg prednisone daily or equivalent) or any other form of immunosuppressive therapy prior to trial treatment.
• History of bleeding disorder, chronic kidney disease, Inflammatory bowel disease.
• History of a major abdominal surgery
• Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, 5262620, Israel

RECRUITING

Related Publications (1)

• Villemin C, Six A, Neville BA, Lawley TD, Robinson MJ, Bakdash G. The heightened importance of the microbiome in cancer immunotherapy. Trends Immunol. 2023 Jan;44(1):44-59. doi: 10.1016/j.it.2022.11.002. Epub 2022 Dec 1.

  PMID: 36464584 DERIVED

MeSH Terms

Conditions

Melanoma

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Gal Markel, MD, PhD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gal N Markel, MD,PhD

CONTACT

+972.3.530.7093; gal.markel@sheba.health.gov.il

Ben S Boursi, MD

CONTACT

+972.3.530.2542; Ben.Boursi@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Scientist of The Ella Lemelbaum Institute of Immuno-Oncology, Principal Investigator, Associate Professor of Immunology

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: November 27, 2017
• Study Start: November 30, 2017
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2021
• Last Updated: April 3, 2019

Record last verified: 2019-04

Locations

IL (1)