Clinical Trial: NCT04758507
Fecal Microbiota Transplantation to Improve Efficacy of Immune Checkpoint Inhibitors in Renal Cell Carcinoma
Status:
COMPLETEDPhase:
Phase 1| Lead Sponsor: | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Information Provided By: | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Last Update Posted: | 2025-09-08 |
Study Overview
Brief Summary
Renal cell carcinoma (RCC) is the sixth most common cancer in men and the eighth in women in the USA. In Italy RCC incidence was 11500 new cases in 2017, while mortality was 3371 cases in 2015. Increasing evidence suggests that response to immune checkpoint inhibitors (ICIs), a novel treatment for advanced RCC (aRCC) and other epithelial tumors, can be influenced by the patient gut microbiota. Fecal microbiota transplantation (FMT) is a novel therapeutic option based on the restoration of healthy gut microbiota, and is the most effective therapy for recurrent C. difficile infection, and preliminary nonrandomized findings show that FMT is able to improve efficacy of ICIs in patients with advanced melanoma. The aim of this study is to evaluate, through a randomized controlled trial, the efficacy of targeted FMT (from donors who are responding to ICI. in improving response rates to ICIs in subjects with aRCC.
Official Title
Conditions
Intervention / Treatment
- Biological: donor FMT
- Other: Placebo FMT
Other Study ID Numbers
- 2664
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Actual)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Information Provided By: | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Last Update Posted: | 2025-09-08 |
Study Overview
Brief Summary
Renal cell carcinoma (RCC) is the sixth most common cancer in men and the eighth in women in the USA. In Italy RCC incidence was 11500 new cases in 2017, while mortality was 3371 cases in 2015. Increasing evidence suggests that response to immune checkpoint inhibitors (ICIs), a novel treatment for advanced RCC (aRCC) and other epithelial tumors, can be influenced by the patient gut microbiota. Fecal microbiota transplantation (FMT) is a novel therapeutic option based on the restoration of healthy gut microbiota, and is the most effective therapy for recurrent C. difficile infection, and preliminary nonrandomized findings show that FMT is able to improve efficacy of ICIs in patients with advanced melanoma. The aim of this study is to evaluate, through a randomized controlled trial, the efficacy of targeted FMT (from donors who are responding to ICI. in improving response rates to ICIs in subjects with aRCC.
Official Title
Conditions
Intervention / Treatment
- Biological: donor FMT
- Other: Placebo FMT
Other Study ID Numbers
- 2664