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
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.
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. |
Country | Name | City | State |
---|---|---|---|
Israel | Sheba Medical Center | Tel HaShomer |
Lead Sponsor | Collaborator |
---|---|
Sheba Medical Center |
Israel,
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 |
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