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

Recruiting Phase 2 Interventional Study
Immune-mediated Colitis (IMC) Immune-related Dermatitis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Diwakar Davar · Other
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About This Trial
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). Thi…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Able to swallow oral medication. * The participant provides written informed consent for the trial. * Willingness to use contraception for duration of trial participation. Male participants: A male participant must agree to use a contraception per protocol during the treatment…
Contacts

Danielle L Bednarz, RN

4126231191

bednarzdl@upmc.edu

CONTACT

Amy Rose, RN

4126478587

kennaj@upmc.edu

CONTACT