Adoptive Tumor-infiltrating Lymphocyte Transfer With Nivolumab for Melanoma

PHASE1CompletedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

September 17, 2020

Primary Completion Date

March 30, 2023

Study Completion Date

March 30, 2023

Conditions
Advanced Melanoma
Interventions
DRUG

Combination of TIL Transfer with anti-PD-1 Therapy and low dose IL-2

"The study uses a personalized IMP, i.e. TIL product and in combination with IL-2 treatment and nivolumab.~Day 0: Autologous TIL: (minimum 5 x 109 and up to a maximum of 2 x 1011 lymphocytes) administered intravenously over 20 to 30 minutes.~Day 0: Interleukin-2 (Proleukin): 125.000 IU/kg/day s.c. for maximum 12 days as inpatients with a 2 days break after the first 4-5 doses (maximum 10 days dosing). Actual body weight will be used in calculating the dose of interleukin-2.~Starting Day 14: Nivolumab application 240 mg i.v. over 30 minutes ever 2 weeks with a maximum to 2 years, or until disease progression or inacceptable toxicity."

Trial Locations (1)

4031

Division of Medical Oncology and Cancer Immunology, University Hospital Basel, Basel

All Listed Sponsors
collaborator

GMP network of Basel

UNKNOWN

lead

University Hospital, Basel, Switzerland

OTHER

NCT04165967 - Adoptive Tumor-infiltrating Lymphocyte Transfer With Nivolumab for Melanoma | Biotech Hunter | Biotech Hunter