Fecal Microbial Transplantation Non-Small Cell Lung Cancer and Melanoma
NCT04951583 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2024-08-07
Summary
The aim of this study is to assess the anti-tumor activity of FMT administered in combination with ICI therapy.
Conditions
- Non Small Cell Lung Cancer Metastatic
- Advanced Melanoma
Interventions
- COMBINATION_PRODUCT
-
FMT + ICI
This study will include 3 cohorts of patients: (1) Patients with advanced or unresectable NSCLC, (2) patients with advanced or unresectable melanoma, and (3) patients with unresectable or advanced uveal melanoma. Patients with NSCLC, melanoma, uveal melanoma and will be analyzed in three separate subgroups given their differing clinical outcomes. Each group will be treated with ICI as per their respective first line options, in combination with investigational FMT capsules.
Sponsors & Collaborators
-
Centre hospitalier de l'Université de Montréal (CHUM)
lead OTHER
Principal Investigators
-
Arielle Elkrief, MD · CHUM
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-11-16
- Primary Completion
- 2024-09-01
- Completion
- 2025-09-01
Countries
- Canada
Study Locations
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