FMT With Nivolumab in Patients With Advanced Solid Cancers Who Have Progressed During Anti-PD-(L)1 Therapy
- Conditions
- Solid Carcinoma
- Interventions
- Other: fecal microbiota transplantation with Nivolumab
- Registration Number
- NCT05533983
- Lead Sponsor
- Asan Medical Center
- Brief Summary
This is a single-center, open-label, Phase 2 study to evaluate the efficacy and safety of FMT with nivolumab in patients with advanced, unresectable, or metastatic solid cancer who have progressed during anti-PD-(L)1 therapy.
- Detailed Description
A single donor-derived FMT will be administered two times in a 2-week interval (± 5 days), which composes one set of FMT. If clinical benefit (complete response \[CR\], partial response \[PR\], or stable disease \[SD\]) is not observed with the 1st set of FMT in the first evaluation of response, the 2nd set of FMT from another donor will be administered unless rapid progression of disease, rapid clinical deterioration, progressive tumor at critical anatomical sites (e.g., cord compression) requiring urgent alternative medical intervention or medical conditions in which further FMT is not the best patient's interest in the opinion of the investigator. If disease progression occurs after achieving clinical benefit (CR, PR, or SD) with the 1st set of FMT, the 2nd set of FMT can be performed using a stool from the same donor as the 1st set of FMT (preferred) or another donor according to the investigator's discretion.
Nivolumab 3 mg/kg iv will be started on day after FMT and followed by additional nivolumab therapy 3 mg/kg iv every 2 weeks until disease progression, intolerable toxicity, or any other of the criteria for treatment discontinuation is met with a maximum of 2-year total duration. In a cycle when FMT is performed, nivolumab will be administered on day after FMT.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Preparation of Frozen Stool Suspensions for FMT fecal microbiota transplantation with Nivolumab The study will enroll patients with advanced, unresectable, or metastatic solid cancer who have progressed during anti-PD-(L)1 therapy.
- Primary Outcome Measures
Name Time Method Overall Response Rate 5year ˙ To evaluate the anti-tumor activity (objective response rate \[ORR\]) of fecal microbiota transplantation (FMT) in combination with nivolumab in patients with advanced solid cancers who have progressed on prior anti-PD-(L)1 based therapy (as monotherapy or combination)
- Secondary Outcome Measures
Name Time Method