Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT03353402
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03353402
Study Brief:
Protocol Section:
NCT03353402