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

No results posted yet for this study

Summary

The aim of this study is to assess the anti-tumor activity of FMT administered in combination with ICI therapy.

Conditions

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04951583 on ClinicalTrials.gov