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Locoregional Administration of TIL and Lymphodepletion in Patients With Melanoma and Liver Metastases

ConditionsUveal MelanomaMetastatic Cutaneous Melanoma
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorVastra Gotaland Region

About this trial

Evaluate the safety and tolerability of treatment with autologous tumor infiltrating lymphocytes (TIL) administered via hepatic arterial infusion and preconditioning with percutaneous hepatic perfusion in patients with liver metastases (but not restricted to) of malignant melanoma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient is willing and able to provide written informed consent and comply with study procedures. Written informed consent must be signed and dated before the start of specific protocol procedures.

stage IV uveal melanoma with or without any previous systemic therapy OR

stage IV cutaneous melanoma with confirmed progression following at least one or two prior systemic therapies including a programmed cell death protein-1 (PD-1) inhibitor with or without a CTLA-4 inhibitor; and if BRAF V600 mutation-positive, also a BRAF inhibitor or a BRAF inhibitor in combination with a MEK inhibitor.

Measurable disease by computed tomography (CT) per RECIST 1.1 criteria with at least one target lesion identified in the liver and where the distribution pattern of metastasis is predominantly engaging the liver as judged by the investigator.

Disqualifiers

Life expectancy of less than 3 months.

Reduced renal function defined as S-Creatinine >=1.5xULN or Creatinine Clearance < 40 mL/min, calculated using the Cockroft and Gault formula.

Reduced hepatic function (defined as ASAT, ALAT, bilirubin > 3*ULN and PK- INR > 1.5) or medical history of liver cirrhosis or portal hypertension.

Hemoglobin <90 g/L or platelets <100x109/L or neutrophils <1.5x109/L

Trial design

Design model

Single group

Treatments tested in this trial

  • Autologous Tumor Infiltrating Lymphocytes

    Drug

    Administered via hepatic arterial infusion (HAI)

  • Melphalan

    Drug

    Administered via isolated hepatic perfusion

  • Interleukin-2

    Drug

    low-dose, administered s.c.

Treatment groups

6 Participants
are divided into 1 treatment group
Group A: Autologous tumor infiltrating lymphocytes (TIL)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Incidence and severity of adverse events

Graded according to Common Terminology Criteria for Adverse Events version 5.0

Time frame
5 years

Secondary outcomes

1

Objective response rate

Defined as the proportion of patients with a best overall response of partial response or better defined by RECIST 1.1

Time frame
5 years
2

Progression-free survival

Defined as the time from inclusion to objective tumor progression (determined by RECIST 1.1), or death due to any cause, whichever occurred first.

Time frame
5 years
3

hepatic Progression-free survival

Defined as the time from inclusion to objective tumor progression in the liver (determined by RECIST 1.1), or death due to any cause, whichever occurred first.

Time frame
5 years
4

Duration of response

Defined as the time from the first documented response and the date of the first documented tumor progression, death, or the last tumor assessment that occurred before subsequent therapy.

Time frame
5 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vastra Gotaland Region

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: