Melanoma Stage IvPhase 1NCT03353402
Fecal Microbiota Transplantation (FMT) in Metastatic Melanoma Patients Who Failed Immunotherapy
A Phase 1 study testing Fecal Microbiota Transplant (FMT) in people with Melanoma Stage Iv and Unresectable Stage III Melanoma, run by Sheba Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma Stage Iv, Unresectable Stage III Melanoma
- What is being tested?
- Fecal Microbiota Transplant (FMT)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 30 Nov 2017to 30 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Tel HaShomer, 5262620
Erez N Baruch, MD, +972.530.4591, Erez.Baruch@sheba.health.gov.il
Ben S Boursi, MD, +972.530.2542, Ben.Boursi@sheba.health.gov.il
About this study
Official title: Altering the Gut Microbiota of Melanoma Patients Who Failed Immunotherapy Using Fecal Microbiota Transplantation (FMT) From Responding Patients
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.
Read the 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
- Being tested
- Fecal Microbiota Transplant (FMT)
- Keywords
- Melanoma, Fecal Microbiota Transplantation, Immunotherapy
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota Transplant (FMT)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Fecal Microbiota Transplant (FMT) | Experimental | FMT includes a colonoscopy conducted by a gastroenterologist followed by stool capsules which will be swallowed by the patient. Receives: Procedure: Fecal Microbiota Transplant (FMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of FMT-related Adverse Events
Number of patients with adverse events that emerged post FMT
Measured: 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
Measured: 4 years
Secondary outcomes (2)
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.
Measured: 4 years
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
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start30 Nov 2017
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Melanoma Stage IvStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Gal Markel, Sheba Medical Center
- Investigators
- Gal Markel, MD, PhD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353402
- Sponsor's protocol ID
- SHEBA-17-3956-GM-CTIL
- Status last verified
- Apr 2019
- First submitted
- 20 Nov 2017
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36464584
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Altering the Gut Microbiota of Melanoma Patients Who Failed Immunotherapy Using Fecal Microbiota Transplantation (FMT) From Responding Patients
- ClinicalTrials.gov ID
- NCT03353402
- Acronym / sponsor ID
- SHEBA-17-3956-GM-CTIL
- Conditions
- Melanoma Stage Iv, Unresectable Stage III Melanoma
- Keywords
- Melanoma, Fecal Microbiota Transplantation, Immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 27 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fecal Microbiota Transplant (FMT) | Experimental | Procedure: Fecal Microbiota Transplant (FMT)FMT includes a colonoscopy conducted by a gastroenterologist followed by stool capsules which will be swallowed by the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Fecal Microbiota Transplant (FMT) |
Primary outcome
Incidence of FMT-related Adverse Events
Time frame: 4 years
Number of patients with adverse events that emerged post FMT
Proper implant engraftment
Time frame: 4 years
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
2 secondary outcomes
Changes in composition of immune cell population
Time frame: 4 years
Changes in activity of immune cells
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- Derived from this study: PubMed 36464584Villemin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gal Markel, MD, PhD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fecal Microbiota Transplant (FMT) in people with Melanoma Stage Iv and Unresectable Stage III Melanoma, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gal N Markel, MD,PhD (+972.3.530.7093, gal.markel@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of FMT-related Adverse Events (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03353402, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2019.