30
Participants
Start Date
June 5, 2017
Primary Completion Date
January 1, 2025
Study Completion Date
June 1, 2026
Fludarabine
Cyclophosphamide 30mg/kg/day with Fludarabine (25 mg/m2/d) followed by 3 consecutive days of Fludarabine 25mg/m2/d.
Cyclophosphamide
Cyclophosphamide 30mg/kg/day with Fludarabine (25 mg/m2/d) followed by 3 consecutive days of Fludarabine 25mg/m2/d.
TIL
TIL administration
IL-2
Bolus high-dose (720,000 IU/kg) IL-2 will be administered to each patient every 8 hours, to tolerance. A maximum of 10 doses will be administered per patient.
Nivolumab
Nivolumab 480 mg fixed dose
Ipilimumab
Ipilimumab 1 mg/kg up to 100 mg
FMT Protocol
"FMT given both directly into the colon via colonoscopy and orally using capsules (12 capsules each time).~FMT will be taken from melanoma patients treated with Anti PD-1 who achieved a durable response of more than 12 months."
RECRUITING
Sheba Medical Center, Ramat Gan
Sheba Medical Center
OTHER_GOV