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

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

November 1, 2020

Primary Completion Date

July 1, 2022

Study Completion Date

July 1, 2023

Conditions
Melanoma Stage IVUnresectable MelanomaNSCLC Stage IV
Interventions
BIOLOGICAL

Fecal Microbial Transplantation by capsules

"Cohorts A and B - Patients will receive 30 oral capsules per administration for two consecutive days (Days 1-2) Cohort C - Patients will receive FMT via colonscopy (Day 1), followed the day after by adnistration of 12 oral capsules (Day 2)~Combination cycles: 6 combined cycles Q2W of FMT maintenance followed by treatment with anti-PD1. Anti-PD-1 will be administered at least one day and up to 3 days after the FMT.~Maintenance of FMT by oral capsules: 12 capsules per administration. Anti PD-1 therapy: A dose of 240 mg Nivolumab will be administrated by intravenous infusion."

Trial Locations (1)

Unknown

RECRUITING

Sheba Medical Center, Ramat Gan

Sponsors
All Listed Sponsors
lead

Ella Therapeutics Ltd

INDUSTRY