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The purpose of this study is to evaluate the feasibility, safety and tolerability of locoregional or systemic administration of autologous tumor infiltrating lymphocytes in patients with metastatic melanoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Patients With Uveal Melanoma and Liver Metastases, locoregional admin using HAI |
|
| Cohort 2 | Experimental | Patients With Cutaneous Melanoma and visceral metastases, IV admin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Tumor Infiltrating Lymphocytes (TIL) | Drug | Cohort 1: Administered via hepatic arterial infusion Cohort 2: Administered via intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events | Incidence and severity of adverse events (AEs) and serious adverse events (SAEs). graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | RECIST 1.1 | 2 years |
| Progression free-survival (PFS) | Evaluation of Progression-free survival | 2 years |
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Inclusion Criteria:
Participants must be at least 18 years of age.
Can provide a signed informed consent as described in the protocol, including compliance with the requirements and restrictions listed in the ICF and in this protocol.
World Health Organization (WHO) Performance Status 0 or 1.
Patient must have a histologically/cytologically confirmed diagnosis of:
At least one resectable lesion in the liver (or aggregate of lesions resected) of a minimum size of 0.5 cm in diameter to generate TILs.
Measurable disease by computed tomography (CT) per RECIST 1.1 criteria after resection of lesion for TILs production
No other malignancies, except if treated with curative intent and with a cancer-related life expectancy of more than 5 years.
Female patient of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female patients of childbearing potential must be willing to use a highly efficient method of contraception (Pearl index <1), for the course of the study through 120 days after the last dose of study medication.
Male patients with women of childbearing potential partners must agree to use a condom for contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lars Ny, PhD | Contact | +46 31 342 40 11 | lars.ny@vgregion.se | |
| Axel Nelson, PhD | Contact | +46 31 342 40 11 | axel.nelson@vgregion.se |
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Cohort 1 Patients With Uveal Melanoma and Liver Metastases, locoregional admin using HAI
Cohort 2 Patients With Cutaneous Melanoma and visceral metastases, IV admin
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| Melphalan | Drug | 1 mg/kg, IV |
|
| Interleukin-2 | Drug | 2 MIU, subcutaneous twice daily for up to 14 days. |
|
| hepatic Progression-free survival (hPFS) | Evaluation of hepatic Progression-free survival | 2 years |
| Duration of objective response (DOR) | Evaluation of duration of a response by RECIST 1.1 | 2 years |
| Overall Survival (OS) | Evaluation of Overall Survival | 5 years |
| Evaluation of feasibility of an automated production of TILs | Defined as the proportion of patients included that receive treatment with the TIL product. | 2 years |
| ID | Term |
|---|---|
| D000098943 | Uveal Melanoma |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D014604 | Uveal Neoplasms |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D008558 | Melphalan |
| D007376 | Interleukin-2 |
| ID | Term |
|---|---|
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |
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