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

Melanoma Stage Iv Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03353402
• Other study ID #: SHEBA-17-3956-GM-CTIL
• Status: Recruiting
• Phase: Phase 1
• Start date: November 30, 2017
• Est. completion date: December 30, 2021

Study information

• Verified date: April 2019
• Source: Sheba Medical Center
• Contact: Gal N Markel, MD,PhD
• Phone: +972.3.530.7093
• Email: gal.markel[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma
• Melanoma Stage Iv
• Unresectable Stage III Melanoma

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel HaShomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Objective Response Rate (ORR)	Number of patients with objective responses divided by the total number of evaluable patients, according to imaging studies (RECIST 1.1) and iRECIST.	4 years
Primary	Incidence of FMT-related Adverse Events	Number of patients with adverse events that emerged post FMT	4 years
Primary	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	Changes in composition of immune cell population	Changes in the relative abundance of different immune cell population (such as the proportion of CD8+ T cells) pre and post-FMT.	4 years
Secondary	Changes in activity of immune cells	Changes in levels of proteins that represent immune activity against cancer (such as measurements of blood interferon gamma levels), pre and post FMT	4 years