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New treatment option for Melanoma Stage III
Official title FMT to Convert Response to Immunotherapy
ClinicalTrials.gov ID: NCT05251389
What this study is testing
- What it's testing
- In this study the aim is to investigate whether transfer of the microbiota of either responder or non-responder patients via fecal microbiotica transplantation (FMT) can convert the response to immunotherapy in immune checkpoint inhibitors (ICI) refractory metastatic melanoma patients. This is a randomized double-blind intervention phase Ib/IIa trial in ICI refractory metastatic melanoma patients receiving either FMT of an ICI responding or FMT from an ICI non-responding donor, in combination with ICI.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients should be 18 years or older
- Patients have pathologically confirmed advanced stage cutaneous melanoma (stage III or IV) requiring systemic treatment with anti-PD-1
- In case of stage IV disease, only patients with M1a or M1b disease are eligible.
- Patients have confirmed disease progression (≥20% increase according to RECIST1.1) on two consecutive scans with a four week interval while on...
- Patients must have measurable disease per RECIST 1.1 criteria
You likely can't join if
- Patients with acral, uveal or mucosal melanoma, or patients with an unknown primary
- Patients who have received treatment for their melanoma other than anti-PD-1 treatment.
- Stage IV patients with M1c or M1d disease.
- Patients with autoimmune diseases: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease, are...
- Patients with any grade 3 or 4 immune-related adverse events still requiring active immunosuppressive medication, apart from endocrinopathies that...
- Patients with brain or LM metastasis.
See the full eligibility criteria
Who can join
- Patients should be 18 years or older
- Patients have pathologically confirmed advanced stage cutaneous melanoma (stage III or IV) requiring systemic treatment with anti-PD-1
- In case of stage IV disease, only patients with M1a or M1b disease are eligible.
- Patients have confirmed disease progression (≥20% increase according to RECIST1.1) on two consecutive scans with a four week interval while on anti-PD-1 treatment, of which the second scan has to be performed within 3...
- Patients must have measurable disease per RECIST 1.1 criteria
- Patients have an ECOG performance status of 0-1 (appendix D)
- Patients have a life expectancy of \>3 months
- Patients have adequate organ function as determined by standard-of-care pre-checkpoint inhibitor infusion lab (including serum ALAT/ASAT less than three times the upper limit of normal (ULN); serum creatinine clearance...
- Patients have an LDH level of ≤1 times ULN
- Patients of both genders must be willing to use a highly effective method of birth control during treatment
- Patients must be able to understand and sign the Informed Consent document
What rules you out
- Patients with acral, uveal or mucosal melanoma, or patients with an unknown primary
- Patients who have received treatment for their melanoma other than anti-PD-1 treatment.
- Stage IV patients with M1c or M1d disease.
- Patients with autoimmune diseases: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease, are excluded from this study (except Hashimoto thyroiditis, vitiligo, history...
- Patients with any grade 3 or 4 immune-related adverse events still requiring active immunosuppressive medication, apart from endocrinopathies that are stable under hormone replacement therapy. Patients who had developed...
- Patients with brain or LM metastasis.
- Patients with an elevated LDH level
- Patients that have undergone major gastric/esophageal/bowel surgery (like Wipple, subtotal colectomy)
- Severe food allergy (e.g. nuts, shellfish)
- Patients with a swallowing disorder or expected bowel passage problems (ileus, fistulas, perforation)
- Severe dysphagia with incapability of swallowing 2 liters of bowel lavage
- Patients with a life expectancy of less than three months
- Patients with severe cardiac or pulmonary comorbidities (per judgement of the investigator)
- Women who are pregnant or breastfeeding
- Patients with any active systemic infections, coagulation disorders or other active major medical illnesses
- Patients with other malignancies, except adequately treated and a cancer-related life-expectancy of more than 5 years
- Patients who received treatment with antibiotics in the three months prior to study enrolment, or patients we are expected to receive systemic antibiotics during the course of this study
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.