NCT03638375

TIL and Anti-PD1 in Metastatic Melanoma

Adoptive TIL Therapy With Low-dose IFN-alpha Plus Anti-PD1 in Metastatic Melanoma

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Leiden University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The ACTME study is an investigator initiated, single center phase I/II clinical trial for patients with progressive unresectable stage III or stage IV melanoma. The trial consists of both a phase I part to determine safety and feasibility and a phase II part to evaluate first clinical activity of IFN-alpha, nivolumab and TIL. The treatment with IFN-alpha will be added after the combination of TIL and nivolumab has proven to be safe.

Detailed description

The ACTME is an investigator initiated, single center phase I/II clinical trial for patients with progressive unresectable stage III or stage IV melanoma. Patients are conditioned by low-dose IFN-alpha and treated with ACT and PD-1 antibodies. With this approach the investigators hope to solve 4 of the most important aspects curtailing the efficacy of current immunotherapies in metastatic melanoma: 1. the lack of sufficient numbers of activated tumor-reactive T cells in patients by providing ACT; and 2. the inhibition of T-cell effector function through PD-1 signalling by administration of nivolumab; as well as 3. the toxicity of high-dose IL-2, and 4. long term hospitalization of patients due to the conditioning-regimen used in most ACT protocols by replacing it with low-dose IFN-alpha treatment. The trial consists of both a phase I part to determine safety and feasibility and a phase II part to evaluate first clinical activity of IFN-alpha, nivolumab and TIL. The treatment with IFN-alpha will be added after the combination of TIL and nivolumab has proven to be safe in the first cohort of the phase I part of the trial.

Conditions

• Toxicity, Drug
• Adverse Drug Event
• Effects of Immunotherapy

Interventions

Type	Name	Description
DRUG	Nivolumab & Tumor Infiltrating Lymphocytes with/without Interferon-Alpha	During 15 weeks patients will be treated with nivolumab (3mg/kg i.v.) once every two weeks. Four weeks after starting nivolumab, patients will receive their first TIL infusion (2.5-7.5x10\^8 T cells i.v.) once every three weeks for three infusions. In the second group treatment with IFN-alpha (3 million IU s.c.) daily will be added one week before the first TIL infusion and will be continued for 11 weeks.

Timeline

• Start date: 2018-07-31
• Primary completion: 2025-11-29
• Completion: 2025-11-29
• First posted: 2018-08-20
• Last updated: 2023-12-12

Locations

1 site across 1 country: Netherlands