TIL-ACT After NMA Chemo with IL-2 and Nivo Rescue in Metastatic Melanoma (mMEL)

Sponsor
Centre Hospitalier Universitaire Vaudois
Study ID
NCT03475134
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TIL — OTHER
    Adoptive transfer of Autologous Tumor-Infiltrating Lymphocytes
  • Cyclophosphamide — DRUG
    Cyclophosphamide will be administered as an intravenous (IV) infusion for two days.
  • Fludarabine — DRUG
    Fludarabine will be administered as an intravenous (IV) infusion for five days.
  • Interleukin-2 — DRUG
    After TIL infusion, IL-2 (optional) will be started as a bolus administration every eight hours, for a maximum of eight doses.
  • Nivolumab — DRUG
    Nivolumab will be administered for maximum 24 months as follows: first year: 240 mg every 2 weeks; second year: 480 mg every 4 weeks.

Study Details

This is a single center, single arm phase I trial to test the feasibility and safety of Tumor- Infiltrating Lymphocyte-Adoptive Cell Therapy (TIL-ACT) followed by nivolumab rescue in unresectable locally advanced or metastatic melanoma patients. The trial is based on lymphodepleting chemotherapy followed by ACT, utilizing ex vivo expanded TILs in combination with high dose interleukin-2 (IL-2) (optional, depending on patient's tolerance), followed by nivolumab rescue (if indicated) for a maximum duration of 2 years.

Key Dates

Start date
Feb 21, 2018
Status verified
Feb 2025
Primary completion
Feb 9, 2021
Completion
Jun 6, 2024

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TIL-ACT +/- Nivolumab rescue
    Non-myeloablative lymphodepleting chemotherapy (cyclophosphamide and fludarabine), Tumor Infiltrating Lymphocyte (TIL)-Adoptive Cell Therapy (ACT), Interleukin-2 (IL-2), Nivolumab rescue

Primary Outcome Measure

Feasibility of TIL-ACT - successful Rapid Expansion Protocol (REP) [ Time Frame: Evaluated for each patient at day 0 (5-10 days after chemotherapy start). After day 0 of the last patient, the number of patients with successful REP/ start of TIL-ACT infusion will be calculated. ]

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