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

NCT03475134 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-02-11

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

TIL

Adoptive transfer of Autologous Tumor-Infiltrating Lymphocytes

DRUG

Cyclophosphamide

Cyclophosphamide will be administered as an intravenous (IV) infusion for two days.

DRUG

Fludarabine

Fludarabine will be administered as an intravenous (IV) infusion for five days.

DRUG

Interleukin-2

After TIL infusion, IL-2 (optional) will be started as a bolus administration every eight hours, for a maximum of eight doses.

DRUG

Nivolumab

Nivolumab will be administered for maximum 24 months as follows: first year: 240 mg every 2 weeks; second year: 480 mg every 4 weeks.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Vaudois

    lead OTHER

Principal Investigators

  • George Coukos, MD, PhD · Department director

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-21
Primary Completion
2021-02-09
Completion
2024-06-06

Countries

  • Switzerland

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03475134 on ClinicalTrials.gov