Actively Recruiting
Healthy-donor Microbiome MTP-101-C in Steroid Relapse/Refractory Immune-related Cutaneous Adverse Events (irCAEs) and Immune-mediated Colitis (IMC)
Led by Diwakar Davar · Updated on 2026-02-09
30
Participants Needed
1
Research Sites
348 weeks
Total Duration
On this page
Sponsors
D
Diwakar Davar
Lead Sponsor
S
Stanley Marks Fund for Cancer Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
Multiple retrospective studies suggest that the administration of corticosteroids to treat irAEs is safe, and does not compromise efficacy of ICI therapy in cancer patients. While \~67% of patients respond to corticosteroids, 33% of patients require biologic therapy such as TNFα inhibitors (e.g. infliximab), integrin α4β7 inhibitors (e.g. vedolizumab), or JAK/STAT inhibitors (e.g. tofactinib). This study aims to determine that distinct pathobionts govern the development of irCAE and IMC; and that the administration of hdFMT may reverse steroid-refractory irCAEs or IMC. The use of hdFMT has been shown to be effective in steroid and biologic (TNFα and/or integrin α₄β₇ inhibitor) refractory colitis in PD-1 and/or CTLA-4 ICI treated cancer patients in single-institution case series.
CONDITIONS
Official Title
Healthy-donor Microbiome MTP-101-C in Steroid Relapse/Refractory Immune-related Cutaneous Adverse Events (irCAEs) and Immune-mediated Colitis (IMC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to swallow oral medication.
- Provides written informed consent.
- Willing to use contraception during the trial and for 120 days after last dose (for males and females of childbearing potential).
- Not pregnant or breastfeeding if female; follows contraception guidelines if a woman of childbearing potential.
- Clinically confirmed inflammatory immune-related cutaneous adverse event (Grade 3 or higher) or endoscopically confirmed immune-mediated colitis (Mayo endoscopic subscore 1-3).
- Prior treatment with anti-PD(L)1 and/or anti-CTLA-4 therapies alone or with other agents.
- For steroid relapsed/refractory Grade ≥3 irCAE cohort: received high-dose corticosteroids (1-2 mg/kg prednisone equivalent) tapered over 4-6 weeks; no prior biologic therapy; symptoms relapsed or refractory.
- For steroid relapsed/refractory Grade ≥3 IMC cohort: received high-dose corticosteroids tapered over 4-6 weeks; no prior biologic therapy including TNFα or integrin inhibitors; symptoms relapsed or refractory.
- Any number of prior systemic therapies allowed.
- Any solid tumor or hematologic malignancy allowed.
- Not receiving concurrent radiation therapy.
- Willing to undergo cohort-specific evaluations including skin or GI assessments and biopsies or endoscopies.
- Willing to provide blood and stool samples.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2; ECOG 2 allowed if decline is due to IMC.
- Adequate organ function confirmed by tests within 7 days before starting study treatment.
You will not qualify if you...
- Having multiple immune-related adverse events besides irCAE or IMC.
- Concurrent Grade 3 or higher immune-related adverse events requiring systemic immune suppression.
- irCAE or IMC types not specified in the protocol.
- Concomitant immune-related adverse events that are well controlled (Grade 1 or 2) unless approved by the investigator.
- Diagnosis of immunodeficiency or immunosuppression or use of immunosuppressive therapy other than steroids/biologics within 7 days before treatment.
- High risk of multidrug-resistant organism colonization (e.g., nursing home residence, age over 85, certain underlying diseases, indwelling medical devices, prior colonization).
- Contraindications to endoscopy (for IMC cohort).
- Contraindications to receiving MTP-101-C.
- Prior head, neck, or abdominal surgery that might affect absorption of oral fecal microbiota capsules.
- Active bacterial infection requiring systemic antibiotics.
- Received live vaccines within 30 days before starting treatment or during the study.
AI-Screening
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Trial Site Locations
Total: 1 location
1
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
Research Team
D
Danielle L Bednarz, RN
CONTACT
A
Amy Rose, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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