NCT04758507CompletedPhase 1/2
Fecal Microbiota Transplantation to Improve Efficacy of Immune Checkpoint Inhibitors in Renal Cell Carcinoma
Targeting Gut Microbiota to Improve Efficacy of Immune Checkpoint Inhibitors in Patients With Advanced Renal Cell Carcinoma
Source: ClinicalTrials.gov · Last updated 8 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 11 Feb 2021
- Start date
- 18 Feb 2021
- Primary completion date
- 16 Dec 2024
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Kidney cancer
- NCT number
- NCT04758507
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 50
- From 18 Feb 2021 to the primary completion date, 16 Dec 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant GI or autoimmune disorders, or HIV, HBV, HCV infection
- Continuative corticosteroid therapy
- Previous treatment with systemic immune-suppressants or immune-modulatory drugs
- Antibiotic therapy within 4 weeks prior to enrollment
Other
- Major comorbidities
Who the study is looking for
- Histologically confirmed aRCC
- Metastatic disease (measurable and not-measurable)
- Radiological assessment within 8 wks before enrollment
- Patient eligible to therapy with ICI for aRCC (or started within 8 wks)
- Ability to provide written informed consent
- Ability to be compliant with the scheduled procedures
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Digestive Disease Center Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| Gianluca Ianiro Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.