A Phase 1 interventional study of Combination of TIL Transfer with anti-PD-1 Therapy and low dose IL-2 in Advanced Melanoma, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-10.
Sponsored by University Hospital, Basel, Switzerland · Phase 1, Interventional, and Treatment
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.
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.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 9 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.
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Exclusion Criteria:
The TIL product will be produced from excised tumor lesions from the patient. 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 transplant product will be produced in the Good Manufacturing Practice (GMP) facility of the University Hospital in Basel. TIL transfer to Patient at Day 0.
Drug: Combination of TIL Transfer with anti-PD-1 Therapy and low dose IL-2
The study uses a personalized IMP, i.e. TIL product and in combination with IL-2 treatment and nivolumab. Day 0: Autologous TIL: (minimum 5 x 109 and up to a maximum of 2 x 1011 lymphocytes) administered intravenously over 20 to 30 minutes. Day 0: Interleukin-2 (Proleukin): 125.000 IU/kg/day s.c. for maximum 12 days as inpatients with a 2 days break after the first 4-5 doses (maximum 10 days dosing). Actual body weight will be used in calculating the dose of interleukin-2. Starting Day 14: Nivolumab application 240 mg i.v. over 30 minutes ever 2 weeks with a maximum to 2 years, or until disease progression or inacceptable toxicity.
Also known as: TIL Transfer, anti-PD-1 Therapy Nivolumab, low dose IL-2
Number of Adverse Events
Number of Adverse Events to analyze safety of the combination of TIL transfer with IL-2 therapy
Time frame: First 3 months during treatment
Change in body temperature (Degree Celsius)
Change in Vital signs ( body temperature) to analyze the safety of the combination of TIL transfer with IL-2 therapy
Time frame: at each treatment visit (Day 0, and for maximum 12 days as inpatients with a 2 days break after the first 4-5 doses (maximum 10 days dosing)
Change in blood pressure (mmHg)
Change in Vital signs ( blood pressure) to analyze the safety of the combination of TIL transfer with IL-2 therapy
Time frame: at each treatment visit (Day 0, and for maximum 12 days as inpatients with a 2 days break after the first 4-5 doses (maximum 10 days dosing)
Change in heart beat (beats/minute)
Change in Vital signs (heart beat) to analyze the safety of the combination of TIL transfer with IL-2 therapy
Time frame: at each treatment visit (Day 0, and for maximum 12 days as inpatients with a 2 days break after the first 4-5 doses (maximum 10 days dosing)
Change in respiratory frequency (inspiration/minute)
Change in Vital signs (respiratory frequency) to analyze the safety of the combination of TIL transfer with IL-2 therapy
Time frame: at each treatment visit (Day 0, and for maximum 12 days as inpatients with a 2 days break after the first 4-5 doses (maximum 10 days dosing)
Change in full blood Counts (number of cells)
Change in Laboratory Parameter (full blood counts) to analyze haematological toxicity
Time frame: at each treatment visit (every 2 weeks) from Day 0= Baseline to week 42
Overall Response Rate (ORR) fluorodeoxyglucose (FDG)-positron emission tomography (PET)/CT scan
Changes of Tumor volume according to RECIST 1.1
Time frame: First 3 months after TIL administration
Progression Free Survival (PFS)
Progression free survival, defined as the time between registration to progression or death whichever occurs first.
Time frame: between pre-treatment and 3-months post-treatment
Overall Survival (OS) defined as the time between registration to death due to any cause
Overall survival will be measured from the beginning of the treatment to the death of the patient or to survival status analysis acquired during the last follow up.
Time frame: 2 years after TIL transfer
Tumor response according to revised Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Tumor response according to revised Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Time frame: between pre-treatment and 3-months post-treatment
Objective response rate (ORR)
In order to assess the objective response rate CT scans and FDG-PET/CT scans will be performed. Response will be measured by best reduction of tumor volume according to RECIST 1.1
Time frame: 2 years after TIL transfer
Number of Adverse Events according to CTCAE 4.0
Overall Safety during whole treatment period analyzed by collection of Adverse Events according to CTCAE 4.0
Time frame: 2 years after TIL transfer
Metabolic Response
Response measured by 18FDG-uptake
Time frame: during the first 3 months after TIL transfer
Number of Serious Adverse Events according to CTCAE 4.0
Overall Safety during whole treatment period analyzed by collection of Serious Adverse Events according to CTCAE 4.0
Time frame: 2 years after TIL transfer
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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University Hospital, Basel, Switzerland