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Study identifier: NCT06499896 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Healthy-donor Microbiome MTP-101-C in Steroid Relapse/Refractory Immune-related Cutaneous Adverse Events (irCAEs) and Immune-mediated Colitis (IMC)

Condition: Immune-mediated Colitis (IMC) · Immune-related Dermatitis  ·  Sponsor: Diwakar Davar

PhasePhase 2
Planned participants30
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Danielle L Bednarz, RN  ·  4126231191  ·  bednarzdl@upmc.edu

Amy Rose, RN  ·  4126478587  ·  kennaj@upmc.edu

Always discuss trial participation with your own doctor first.

Locations (1)

UPMC Hillman Cancer CenterPittsburgh, Pennsylvania, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT06499896