Spots Global Cancer Trial Database for Microbiota Transplant to Cancer Patients Who Have Failed Immunotherapy Using Faeces From Clinical Responders

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Trial Identification

Brief Title: Microbiota Transplant to Cancer Patients Who Have Failed Immunotherapy Using Faeces From Clinical Responders

Official Title: MITRIC: Microbiota Transplant to Cancer Patients Who Have Failed Immunotherapy Using Faeces From Clincal Responders

Study ID: NCT05286294

Conditions

Melanoma Stage IV

Head and Neck Squamous Cell Carcinoma

Cutaneous Squamous Cell Carcinoma

MSI-High

Clear Cell Renal Cell Carcinoma

Non-small Cell Lung Cancer

Interventions

Fecal Microbiota Transplant (FMT)

Study Description

Brief Summary: This is a single-arm, single-center, open-label, phase IIa study evaluating the safety, feasibility and efficacy of Faecal Microbiota Transplant (FMT) to cancer patients not responding to ICI therapy, using ICI-responders as donors.

Detailed Description: Immunotherapy with immune checkpoint inhibitors (ICI) has shown remarkable clinical efficacy against several cancer forms. This includes durable responses in patients with metastatic cancers and no other effective treatment options. However, many patients do not respond. This leaves a major challenge; how to turn non-responders into responders. Herein, this challenge is addressed, by attempting to modulate patients' intestinal microbiota through Faecal Microbiota Transplant (FMT). Data from several preclinical and translational studies have indicated that the microbiota composition is important for the effect of ICIs. Moreover, two recent trials exploring FMT for melanoma patients have suggested acceptable safety and a potential clinical benefit.