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Tests treatment safety and results for Immune-related Colitis
Official title A Pilot Study Testing the Safety and Feasibility of Restorative Microbiota Therapy (RMT) in Patients With Refractory Immune-checkpoint Inhibitor-related Colitis
ClinicalTrials.gov ID: NCT05726396
What this study is testing
What is RMT?
RMT is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for immune-related colitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Immune-related colitis from immune checkpoint inhibitors (ICI) is a common adverse effect causing significant morbidity and impairment of quality of life (QoL). Steroids are the first line of treatment for severe ICI induced Immune- mediated diarrhea and colitis (IMDC).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, 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
- Localized, locally advanced or metastatic solid tumors who have received at least two doses of ICI (PD-1/PD-L1 with or without CTLA-4 inhibitor).
- ICI used as a single agent, or combination or ICI in combination with other cytotoxic chemotherapy or targeted therapy for curative or palliative...
- Last ICI treatment with in 6 weeks of onset of IMDC symptoms
- Meet one of the criteria for steroid refractory IMDC defined as:
- Persistent symptoms (NCI CTCAE v 5.0 Grade ≥ 2 diarrhea) following high-dose corticosteroid therapy (≥1 mg/kg/day prednisone or equivalent) for least...
You likely can't join if
- Diagnosis of concomitant infectious colitis based on standard stool screening including stool microscopy for ova and parasites, stool PCR for...
- Last cytotoxic chemotherapy or targeted therapy less than 3 week prior to screening
- Patients anticipated to require cytotoxic chemotherapy or targeted therapy through the end of treatment EOT period (30 days following first dose of...
- Known current pregnancy or breastfeeding.
- Receiving another investigational agent or has received an investigational agent within 60 days of study enrollment.
- Any other uncontrolled Grade ≥3 infection at the time of enrollment (Concomitant systemic antibiotics for non-GI infections are allowed).
See the full eligibility criteria
- Localized, locally advanced or metastatic solid tumors who have received at least two doses of ICI (PD-1/PD-L1 with or without CTLA-4 inhibitor).
- ICI used as a single agent, or combination or ICI in combination with other cytotoxic chemotherapy or targeted therapy for curative or palliative intent treatment.
- Last ICI treatment with in 6 weeks of onset of IMDC symptoms
- Meet one of the criteria for steroid refractory IMDC defined as:
- Persistent symptoms (NCI CTCAE v 5.0 Grade ≥ 2 diarrhea) following high-dose corticosteroid therapy (≥1 mg/kg/day prednisone or equivalent) for least 48 hours or
- Persistent symptoms (ongoing Grade ≥ 2 diarrhea per CTCAE v5.0.) following use of a one or more biologic agent (i.e. either a TNFα inhibitor or an anti-integrin) in addition to corticosteroids (with starting dose of...
- For patients with relapsed IMDC who have discontinued steroids: Relapsed IMDC symptoms for 24 or more hours (NCI CTCAE v 5.0 Grade ≥ 2 diarrhea) within 4 weeks of discontinuing prednisone or equivalent. These patients...
- For patients with relapsed IMDC following the tapering of steroids Relapsed IMDC symptoms for 24 or more hours (NCI CTCAE v 5.0 Grade ≥ 2 diarrhea) while the prednisone taper is on-going. These patients should have...
- Adequate organ function within 14 days prior to study enrollment defined as:
- Hematology: Hemoglobin ≥9.0 g/dL, absolute neutrophil count (ANC) ≥1,000/mcL, platelets ≥75,000/mcL,
- Hepatic function: Total bilirubin ≤ 1.5x upper limit of normal (ULN), AST (SGOT) and ALT (SGPT) ≤ 2.5 x institutional ULN unless liver metastases are present, in which case it must be ≤5x ULN)
- Renal function: measured creatinine clearance \>40 mL/min or estimated glomerular filtration rate (GFR) \>40 mL/min If AST/ALT and serum creatinine elevation are suspected to be irAEs, patients are eligible as long as...
- Well controlled diabetes with HbA1c of \<8 with in 6 months of screening
- Euvolemic on physical examination
- Stable vital signs at screening and enrollment that includes
- Body temperature 95.8 to 99.9°F
- Heart rate between 60-100/min
- Blood pressure 90-140/60-90 mm of Hg.
- Must be on standard antidiarrheal supportive care for at least 1 day prior to starting RMT. The regimen consists of: loperamide 2-4 mg every 6 hours (up to 16 mg /day) and/or diphenoxylate 5 mg/ atropine sulfate 0.05 mg...
- Age 18 years of age or older at the time of consent
- Body weight of \>30 kg
- Expected survival for at least 6 months in the opinion of the enrolling investigator as documented in the medical record
- Voluntary written consent prior to the performance of any research related activity.
- Diagnosis of concomitant infectious colitis based on standard stool screening including stool microscopy for ova and parasites, stool PCR for Clostridioides difficile, and locally available common enteric bacterial...
- Last cytotoxic chemotherapy or targeted therapy less than 3 week prior to screening
- Patients anticipated to require cytotoxic chemotherapy or targeted therapy through the end of treatment EOT period (30 days following first dose of RMT)
- Known current pregnancy or breastfeeding.
- Receiving another investigational agent or has received an investigational agent within 60 days of study enrollment.
- Any other uncontrolled Grade ≥3 infection at the time of enrollment (Concomitant systemic antibiotics for non-GI infections are allowed).
- Previous documented history of chronic diarrhea from non-IMDC causes (For example: inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
- Known dysphagia or inability to swallow study capsules (CTCAE v5 Dysphagia Grade ≥2 - symptomatic and altered eating/swallowing).
- Known risk of aspiration based on history or current complaints.
- Has a known sensitivity to any component of therapeutic agents used in this study.
- On intravenous biologic agents for other baseline autoimmune conditions.
- Other concomitant uncontrolled irAE's at the time of enrollment which would require systemic corticosteroids or biologic immunomodulatory agents.
- On chronic systemic antibiotic therapy (antibiotics for ≥60 consecutive days within 12 weeks of enrollment).
- Receipt of over-the-counter probiotics in the last 4 weeks
- Receipt of live attenuated vaccination within 30 days of receiving RMT. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chickenpox (except shingrix), yellow fever...
- Psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Brainerd, Minnesota, United States
- Deer River, Minnesota, United States
- Detroit Lakes, Minnesota, United States
- Duluth, Minnesota, United States
- Fosston, Minnesota, United States
- Hibbing, Minnesota, United States
- Minneapolis, Minnesota, United States
- Sandstone, Minnesota, United States
- Virginia, Minnesota, United States
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 Brainerd, Minnesota, United States; Deer River, Minnesota, United States; Detroit Lakes, Minnesota, United States; Duluth, Minnesota, United States; Fosston, Minnesota, United States; Hibbing, Minnesota, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.