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

NCT ID: NCT03353402

Last Updated: 2019-04-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-30
• Study Completion Date: 2021-12-30

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.

Detailed Description

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.

Conditions

Melanoma Stage Iv; Unresectable Stage III Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fecal Microbiota Transplant (FMT)

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

Group Type: EXPERIMENTAL

Fecal Microbiota Transplant (FMT)

Intervention Type: 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.

Interventions

Fecal Microbiota Transplant (FMT)

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Prof. Gal Markel

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gal Markel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

Sheba Medical Center

Tel Litwinsky, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Gal N Markel, MD,PhD

Role: CONTACT

gal.markel@sheba.health.gov.il

+972.3.530.7093

Ben S Boursi, MD

Role: CONTACT

Ben.Boursi@sheba.health.gov.il

+972.3.530.2542

Facility Contacts

Erez N Baruch, MD

Role: primary

Erez.Baruch@sheba.health.gov.il

+972.530.4591

Ben S Boursi, MD

Role: backup

Ben.Boursi@sheba.health.gov.il

+972.530.2542

References

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.

Reference Type: DERIVED

PMID: 36464584 (View on PubMed)

Other Identifiers

SHEBA-17-3956-GM-CTIL

Identifier Type: -

Identifier Source: org_study_id