TIL and Anti-PD1 in Metastatic Melanoma

Sponsor
Leiden University
Study ID
NCT03638375
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

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

Eligibility Criteria

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

Interventions

  • Nivolumab & Tumor Infiltrating Lymphocytes with/without Interferon-Alpha — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jul 31, 2018
Status verified
Dec 2023
Primary completion
Nov 29, 2025
Completion
Nov 29, 2025

Study Design

Enrollment
34 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment with nivolumab plus TIL
    In the first cohort the subcutaneous IFN-alpha injections will be omitted and the combination of nivolumab and TIL is given. * Nivolumab is given 3mg/kg i.v. once every two weeks and starts 4 weeks before the first TIL infusion * TILs are given at a dose ranging between 2.5-7.5x10\^8 T cells i.v. once every three weeks, three times per cycle.
  • Experimental: Treatment with Nivolumab plus TIL and IFN-alpha
    In the second cohort of the first phase and the second phase of the trial patients will be treated with subcutaneous IFN-alpha injections in combination with TIL and nivolumab. * IFN-alpha is given at a fixed dose of 3 million IU s.c. every day, for 11 weeks, starting one week before the first TIL infusion * Nivolumab is given 3mg/kg i.v. once every two weeks and starts 4 weeks before the first TIL infusion * TILs are given at a dose ranging between 2.5-7.5x10\^8 T cells i.v. once every three weeks, three times per cycle.

Primary Outcome Measure

Incidence of treatment-related serious adverse events as assessed by CTCAE 4.0 criteria [ Time Frame: 14 weeks after start of treatment ]

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