Uveal MelanomaPhase 1HAITILS-PHPNCT05903937
Locoregional Administration of TIL and Lymphodepletion in Patients With Melanoma and Liver Metastases
A Phase 1 study testing Autologous Tumor Infiltrating Lymphocytes, Melphalan and Interleukin-2 in people with Uveal Melanoma and Metastatic Cutaneous Melanoma, run by Vastra Gotaland Region.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveal Melanoma, Metastatic Cutaneous Melanoma
- What is being tested?
- Autologous Tumor Infiltrating Lymphocytes, Melphalan and Interleukin-2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2027to 31 Dec 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patient must have a histologically/cytologically confirmed diagnosis of:
- 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.
- At least one resectable lesion in the liver (or aggregate of lesions resected) of a minimum size of 0.5 cm in diameter post- resection to generate TILs.
- ECOG performance status of 0 - 1.
Who cannot join
- 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
- Use of live vaccines four weeks before or after the start of study.
- Infection of human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), hepatitis B or hepatitis C.
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- Active autoimmune disease.
- A condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses >10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
- Concomitant therapy with any other anti- cancer therapy, concurrent medical conditions requiring use of immunosuppressive medications or use of other investigational drugs.
- Has a known additional malignancy of other diagnosis that is progressing or requires active treatment.
- A history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Axel Nelson contact
About this study
Official title: Hepatic Arterial Infusion of Autologous Tumor Infiltrating Lymphocytes Preconditioned With Percutaneous Hepatic Perfusion With Melphalan in Patients With Melanoma and Liver Metastases
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
- Conditions
- Uveal Melanoma, Metastatic Cutaneous Melanoma
- Being tested
- Autologous Tumor Infiltrating Lymphocytes, Melphalan, Interleukin-2
- Keywords
- TIL, ACT, PHP
- Medical subject headings
- Uveal Melanoma, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Tumor Infiltrating LymphocytesDrug
Administered via hepatic arterial infusion (HAI)
MelphalanDrug
Administered via isolated hepatic perfusion
Interleukin-2Drug
low-dose, administered s.c.
| Study group | Role | What they receive |
|---|---|---|
| Autologous tumor infiltrating lymphocytes (TIL) | Experimental | Not described Receives: Drug: Autologous Tumor Infiltrating Lymphocytes; Drug: Melphalan; Drug: Interleukin-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events
Graded according to Common Terminology Criteria for Adverse Events version 5.0
Measured: 5 years
Secondary outcomes (6)
Objective response rate
Defined as the proportion of patients with a best overall response of partial response or better defined by RECIST 1.1
Measured: 5 years
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.
Measured: 5 years
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.
Measured: 5 years
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.
Measured: 5 years
Overall survival
Defined as the time from inclusion to the date of death due to any cause
Measured: 5 years
Evaluation of Tolerability
Defined as the proportion of patients included that receive PHP and TIL
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start31 Jan 2027 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveal MelanomaStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05903937
- Sponsor's protocol ID
- 2023-006126-32
- Other IDs
- 2023
- Acronym
- HAITILS-PHP
- Status last verified
- Sep 2026
- First submitted
- 5 Jun 2023
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Arterial Infusion of Autologous Tumor Infiltrating Lymphocytes Preconditioned With Percutaneous Hepatic Perfusion With Melphalan in Patients With Melanoma and Liver Metastases
- ClinicalTrials.gov ID
- NCT05903937
- Acronym / sponsor ID
- HAITILS-PHP / 2023-006126-32
- Conditions
- Uveal Melanoma, Metastatic Cutaneous Melanoma
- Keywords
- TIL, ACT, PHP
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 31 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous tumor infiltrating lymphocytes (TIL) | Experimental | Drug: Autologous Tumor Infiltrating Lymphocytes, Drug: Melphalan, Drug: Interleukin-2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- Patient must have a histologically/cytologically confirmed diagnosis of:
- 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.
Key exclusion criteria (11 listed)
- 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
- Use of live vaccines four weeks before or after the start of study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Tumor Infiltrating LymphocytesAdministered via hepatic arterial infusion (HAI) | Drug | Autologous tumor infiltrating lymphocytes (TIL) |
| MelphalanAdministered via isolated hepatic perfusion | Drug | Autologous tumor infiltrating lymphocytes (TIL) |
| Interleukin-2low-dose, administered s.c. | Drug | Autologous tumor infiltrating lymphocytes (TIL) |
Primary outcome
Incidence and severity of adverse events
Time frame: 5 years
Graded according to Common Terminology Criteria for Adverse Events version 5.0
6 secondary outcomes
Objective response rate
Time frame: 5 years
Progression-free survival
Time frame: 5 years
hepatic Progression-free survival
Time frame: 5 years
Duration of response
Time frame: 5 years
Overall survival
Time frame: 5 years
Evaluation of Tolerability
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Axel Nelson contact
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous Tumor Infiltrating Lymphocytes, Melphalan and Interleukin-2 in people with Uveal Melanoma and Metastatic Cutaneous Melanoma, run by Vastra Gotaland Region.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lars Ny (+46 31 342 10 00, lars.ny@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.