Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04758507
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-10
First Post:
2021-02-11
Brief Title:
Fecal Microbiota Transplantation to Improve Efficacy of Immune Checkpoint Inhibitors in Renal Cell Carcinoma
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Targeting Gut Microbiota to Improve Efficacy of Immune Checkpoint Inhibitors in Patients With Advanced Renal Cell Carcinoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TACITO
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
Detailed Description:
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 the 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 So the investigators will investigate through a randomized controlled trial if donor FMT will be more effective than placebo FMT in improving response to ICIs in patients with renal cell carcinoma Patients will undergo the first infusion by colonoscopy Then patients will receive frozen fecal capsules 8 capsules tid at 3 and 6 months after the first FMT
Fifty patients will be enrolled Sample size calculation was based on the hypothesis of the superiority of FMTSOC over SOC alone The 1-year PFS rate for SOC has been reported to be nearly 60 The alternative hypothesis is that FMT can improve the 1-year PFS rate from 60 to 80 wen associated to SOC A total of 50 patients will enter this two-treatment parallel-design study The probability is 80 percent that the study will detect a treatment difference at a one-sided 50 percent significance level if the true hazard ratio is 0436 This is based on the assumption that the accrual period will be 36 months and the follow up period will be 36 months and the median survival is 151 months The total number of events will be 37
Fifty patients will be enrolled Sample size calculation was based on the hypothesis of the superiority of FMTSOC over SOC alone The 1-year PFS rate for SOC has been reported to be nearly 60 The alternative hypothesis is that FMT can improve the 1-year PFS rate from 60 to 80 wen associated to SOC A total of 50 patients will enter this two-treatment parallel-design study The probability is 80 percent that the study will detect a treatment difference at a one-sided 50 percent significance level if the true hazard ratio is 0436 This is based on the assumption that the accrual period will be 36 months and the follow up period will be 36 months and the median survival is 151 months The total number of events will be 37
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None