drugset / Trial / NCT04521075

A Phase Ib Trial to Evaluate the Safety and Efficacy of FMT and Nivolumab in Subjects With Metastatic or Inoperable Melanoma, MSI-H, dMMR or NSCLC

NCT04521075 ↗

Phase 1/2 Unknown 42 enrolled Ella Therapeutics Ltd
NaSingle-groupOpen-labelTreatment

Summary

A Phase Ib trial to evaluate the safety and efficacy of Fecal Microbial Transplantation (FMT) in combination with Nivolumab in subjects with metastatic or inoperable melanoma, microsatellite instability-high (MSI-H) or mismatch-repair deficient (dMMR) cancer, or Non-Small Cell Lung Cancer (NSCLC)

Timeline

Start
2020-11-01
Primary completion
2022-07-01
Completion
2023-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Nivolumab Monoclonal antibody 240 mg Intravenous