Adoptive Tumor-infiltrating Lymphocyte Transfer With Nivolumab for Melanoma

  • STATUS
    Recruiting
  • End date
    Aug 25, 2025
  • participants needed
    9
  • sponsor
    University Hospital, Basel, Switzerland
Updated on 25 January 2021
platelet count
metastatic melanoma
interleukin
cyclophosphamide
measurable disease
gilbert's syndrome
metastasis
neutrophil count
liver metastasis
nivolumab
hepatitis b antigen

Summary

This study is to investigate safety and feasibility of a combination therapy of a tumor infiltrating lymphocytes (TIL) transfer with anti-programmed cell death protein (PD)-1 therapy in patients with metastatic melanoma that failed immunotherapy.Tumor-infiltrating lymphocytes will be expanded from resected melanoma samples from the patient and expanded TILs will be transferred to the patient after non-myeloablative chemotherapy with cyclophosphamide and fludarabine. TIL transfer will be combined with low dose Interleukin (IL)-2 and nivolumab anti-PD-1 treatment.

The study uses a personalized Investigational Medicinal Product (IMP), i.e. TIL product and in combination with IL-2 treatment and nivolumab.

Description

Adoptive cell therapy has been previously shown to be an effective treatment option for patients with melanoma. Due to an immunosuppressive microenvironment, not all patients respond to this therapy. In this trial, the immune suppressive microenvironment will be targeted by adding a PD-1 blocking antibody in combination with a TIL Transfer. Tumor-infiltrating lymphocytes will be expanded from resected melanoma samples from the patient and expanded TILs will be transferred to the patient after non-myeloablative chemotherapy with cyclophosphamide and fludarabine. TIL transfer will be combined with low dose IL-2 and nivolumab anti-PD-1 treatment. The study uses a personalized IMP, i.e. TIL product and in combination with IL-2 treatment and nivolumab.

Details
Condition Advanced Melanoma
Treatment Combination of TIL Transfer with anti-PD-1 Therapy and low dose IL-2
Clinical Study IdentifierNCT04165967
SponsorUniversity Hospital, Basel, Switzerland
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have Advanced Melanoma?
Do you have any of these conditions: Do you have Advanced Melanoma??
Histologically confirmed unresectable or metastatic melanoma
At least 1 PD-1 targeted immunotherapy and BRAF inhibition in case of BRAF mutated melanoma
Resectable tumor mass and measurable disease by CT or MRI per RECIST 1.1 criteria (in addition to the resected lesion)
World Health Organization (WHO) clinical performance Status (ECOG) 0-1
Adequate organ function
Patients of both genders must be willing to practice a highly effective method of birth control during treatment and for five months after receiving the last dose of nivolumab for women and seven months for men
Patients must be able to understand and sign the Informed consent document
Hematology: Absolute neutrophil count greater than 1.5 x 109/L without support of filgrastim. Platelet count greater than 100 x 109/L. Hemoglobin greater than 5 mmol/L, or 80 g/L
Chemistry: Serum alanine aminotransferase (ALAT)/ aspartate transaminase (ASAT) less than 3 times the upper limit of normal, unless patients have liver metastases (< 5 times ULN). Serum creatinine clearance 50 ml/min or higher. Total Bilirubin less than or equal to 20 micromol/L, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 50 micromol/L. Lactate dehydrogenase (LDH) 2x ULN
Serology: Seronegative for HIV antibody. Seronegative for hepatitis B antigen, and hepatitis C antibody. Seronegative for syphilis

Exclusion Criteria

Life expectancy of less than three months
Patients with metastatic ocular/ mucosal or other non-cutaneous melanoma
Requirement for immunosuppressive doses of systemic corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressive drugs within the last 3 weeks prior to randomization
Uncontrolled central nervous system (CNS) metastases. Controlled CNS metastases must be for at least 4 weeks stable
Documented Forced expiratory volume at one second (FEV1) less than or equal to 50% predicted for patients with
A prolonged history of cigarette smoking (greater than 20 pack/year within the past 2 years)
Symptoms of respiratory distress
All patients' toxicities due to prior non-systemic treatment must have recovered to a grade 1 or less. Patients may have undergone minor surgical procedures or focal palliative radiotherapy (to non-target lesions) within the past 4 weeks, as long as all toxicities have recovered to grade 1 or less
Women who are pregnant or breastfeeding, because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant
Any active systemic infections, coagulation disorders or other active major medical illnesses
Contraindication for IL-2 or nivolumab (allergies etc.)
Any autoimmune disease: patients with a documented history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease are excluded from this study as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, autoimmune thyroiditis (e.g. Hashimoto's disease), autoimmune hepatitis, systemic progressive sclerosis (scleroderma), Systemic Lupus Erythematosus, autoimmune vasculitis (e.g., Wegener's Granulomatosis). Subjects with motor neuropathy considered of autoimmune origin (e.g., Guillain-Barr Syndrome) are excluded from this study. Patients with vitiligo are eligible to enter the study
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