AzTrials
AzTrials

Advanced MelanomaPhase 1BaseTIL-03MNCT05869539

ACT-TIL and ANV419 for Advanced Melanoma.

A Phase 1 study testing Combination of Tumor-infiltrating lymphocyte transfer with ANV419 in people with Advanced Melanoma, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

In this study we aim to investigate safety and tolerability of tumor-infiltrating lymphocytes (TIL) adoptive cell therapy (ACT) incorporation in-vivo TIL expansion with ANV419 in patients with advanced melanoma Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Melanoma
What is being tested?
Combination of Tumor-infiltrating lymphocyte transfer with ANV419
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteSwitzerland
Study dates
21 Jun 2023to Jun 2026
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

  • Patients who meet all the following criteria will be eligible to participate in the study:
  • Must provide written informed consent for the study.
  • Must be able to comply with the study protocol as judged by the investigator.
  • Are ≥ 18 years. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
  • Have pathologically confirmed stage III (unresectable) or stage IV (metastatic) cutaneous melanoma, as per the American Joint Committee on Cancer staging system, 8th edition, and have experienced disease progression and exhausted all approved treatment option with curative intent.
  • Have received at least one prior systemic treatment line of PD-(L)1 inhibitor and BRAF/MEK inhibition in case of BRAFV600 mutated melanoma. Adjuvant systemic treatment terminated ≥12 months prior to diagnosis of metastatic disease is not counted as a treatment line.
Show all 11Show fewer
  • Accessible tumor lesion(s) for TIL collection and willingness of the patient to undergo biopsy/resection of tumor lesion(s).
  • Measurable disease as per RECIST v1.1 (following biopsy/resection of tumor lesion(s) for TIL collection).
  • Adequate organ function (pulmonary, cardiovascular, hematological, hepatic, and renal function) per investigator's judgment. Cardiac stress testing is mandatory for all patients with underlying cardiac conditions and patients with age ≥50 years. 10. Female patients of childbearing potential must have a negative serum pregnancy test at the screening visit and a negative serum pregnancy test within 72 hours prior to start of preparative chemotherapy (day -7 in the study protocol).
  • Female patients who are not postmenopausal, and who have not undergone surgical sterilization, must agree to use highly effective methods of contraception during the entire study period and for 6 months after the last dose of study drug. They must also agree not to donate eggs (ova, oocytes) during the same timeframe.
  • Male patients with partners of childbearing potential must agree to use highly effective methods of contraception and barrier contraception (condom) during the entire study period and for 6 months after the last dose of study drug. They must also agree not to donate sperm during the same timeframe.

Who cannot join

  • LDH (lactate dehydrogenase) ≥ 2x upper limit of normal (ULN).
  • Life-expectancy ≤ 3 months per investigator's judgment.
  • Have not recovered (i.e., ≤ Grade 1 or at baseline with the exception of alopecia or fatigue [up to Grade 2 allowed]) from immune-related adverse events (irAEs) resulting from prior immunotherapies. Patients who have endocrine immune-related AEs controlled by replacement therapy (i.e., hypothyroidism) due to previous treatment are eligible provided replacement therapy has been initiated and toxicity has returned to Grade 1.
  • Have not recovered (i.e., ≤ Grade 1 or at baseline) from toxicities due to a previously administered chemotherapy, targeted small molecule therapy, or radiation therapy.
  • Note: If the patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study drug. Major surgery is defined as any surgery requiring entrance into a body cavity (e.g., chest, abdomen, or brain), organ removal, normal anatomy alteration, or joint replacement. Minor surgery is defined as any surgery in which skin, mucosa, or connective tissue sections are altered (e.g., biopsy, cataract, endoscopic procedures, etc.).
  • Have been diagnosed with uveal/ocular or mucosal melanoma.
Show all 27Show fewer
  • Have a known additional malignancy (including all in-situ carcinoma) that is progressing or required active treatment within 2 years prior to enrollment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that have undergone potentially curative therapy and have no evidence of disease or in situ cervical cancer in patients who completed cancer-directed therapy or have evidence of stable disease and do not require active treatment.
  • Have active central nervous system metastases and/or carcinomatous meningitis regardless of clinical stability. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to study treatment (day -7 in the study protocol), and any neurologic symptom has returned to baseline. New or enlarging brain metastases, as well as the use of steroids (≥10 mg of prednisone daily or equivalent) within the last 7 days prior to study drug are excluded.
  • Have a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to study treatment (day -7 in the study protocol).
  • Are receiving systemic steroid ≥10 mg of prednisone daily or equivalent for any reason. Local steroid therapies (e.g., otic, ophthalmic, intra-articular, or inhaled medications) are acceptable. -
  • Have an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 11. Have a known history of, or any evidence of active, non-infectious pneumonitis.
  • Have an active (measurable) and uncontrolled (unresponsive to current therapy) infectious disease (bacterial, fungal, viral, protozoic).
  • Have a history of an acute coronary event (e.g., myocardial infarction) within 3 months prior to study treatment (day -7 in the study protocol), uncontrolled and symptomatic coronary artery disease, or congestive heart failure New York Heart Association Class III/IV.
  • Have an average QTc interval > 470 msec at ECG-screening.
  • Have 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 it is not in the best interest of the patient to participate, in the opinion of the treating investigator.
  • Have known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
  • Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Screening Visit through 6 months after the last dose of study drug.
  • Are known to be human immunodeficiency virus (HIV) positive (or tests positive for HIV 1 or 2 at Screening), unless the following criteria are met:
  • Cluster of differentiation (CD)4+ lymphocyte count > 350 μL.
  • Had no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the past 12 months.
  • Have been on established anti-retroviral therapy for at least 4 weeks.
  • Have an HIV viral load of > 400 copies/mL prior to study treatment (day -7 in the study protocol).
  • Note: Patients on strong cytochrome P450 (CYP)3A4 inhibitors or strong CYP3A4 inducers must be switched to an alternate effective anti-retroviral therapy regimen prior to study treatment or are excluded if regimen prior to study treatment cannot be altered.
  • Have uncontrolled hepatitis B infection or hepatitis C infection. Note: Patients with hepatitis B (positive hepatitis B surface antigen) who have controlled infection (serum hepatitis B virus DNA by polymerase chain reaction that is below the limit of detection and receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of hepatitis B virus DNA. Note: Patients with hepatitis C (positive hepatitis C virus antibody) who have controlled infection (undetectable hepatitis C virus RNA by polymerase chain reaction either spontaneously or in response to a successful prior course of anti-hepatitis C virus therapy) are permitted.
  • Have received a live vaccine within 30 days of study treatment (day -7 in the study protocol). Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
  • Are positive for SARS-CoV2.
  • Known hypersensitivity to any of the study therapies or drugs used for TIL production. - Any other conditions/diseases, dysfunctions, and/or findings, that would contraindicate the use of any of the study interventions or therapies.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University Hospital Basel

    Basel, Basel, 4031

Other trials in Switzerland

About this study

Official title: A Phase I Trial of Adoptive Cell Therapy With Tumor-Infiltrating Lymphocytes and ANV419 in Patients With Advanced Melanoma. The BaseTIL-03M Trial

In this study we aim to investigate safety and tolerability of tumor-infiltrating lymphocytes (TIL) adoptive cell therapy (ACT) incorporation in-vivo TIL expansion with ANV419 in patients with advanced melanoma

Read the detailed description

In brief, this trial consists of four study periods: screening, pre-treatment, treatment, and observational follow-up.

In the screening period, patients are screened for trial eligibility. In the pre-treatment period, patients have excisional biopsy/surgical resection of tumor lesion(s) (tumor collection) and TILs are expanded from this lesion/these lesions (TIL expansion). Patients are permitted to receive bridging therapy outside of the study protocol.

In the treatment period, patients have TIL-ACT. TIL-ACT includes a detailed procedure of preparative chemotherapy, followed by transfer of the TIL product, followed by in-vivo TIL expansion with ANV419 (2 doses). TIL transfer is defined as day 0 in the study protocol. Patients have an End of Treatment visit (14 days after the last study treatment), a safety follow-up (30 days after the last study treatment) and an efficacy follow up, which is the End of Study visit (day +90).

Thereafter, patients will transfer to observational follow-up, which is conducted every 3 months until 1 year after TIL transfer.

Patients who terminate the study prematurely during any of the treatment period due to e.g., disease progression, toxicity, patient wish, etc. will also transfer to observational follow-up.

The regimen (TIL-ACT with ANV419) has not been tested. Review by the IDSMB (independent data safety monitoring board) will be performed after 3 patients (safety check).

Being tested
Combination of Tumor-infiltrating lymphocyte transfer with ANV419
Keywords
adoptive cell therapy, tumor-infiltrating lymphocytes, ANV419

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combination of Tumor-infiltrating lymphocyte transfer with ANV419Drug

    The study uses a personalized IMP (investigational medicinal product), i.e. TIL product in combination with ANV419.

    Day 0: Autologous TIL: (minimum 5 x 10^9 and up to 2x 10^11 lymphocytes) administered intravenously over 20 to 30 minutes.

    Day 0: Intravenous treatment with ANV419 at 243 μg/kg 2 hours after the TIL infusion. Actual body weight will be used to calculate the dose of ANV419.

    Day14: Intravenous treatment with ANV419 at 243 μg/kg. Actual body weight will be used to calculate the dose of ANV419.

Study groups in NCT05869539
Study groupRoleWhat they receive
Tumor-infiltrating lymphocyte transfer combined with ANV419ExperimentalPatients have excisional biopsy/surgical resection of tumor lesion(s) (tumor collection) and TILs are expanded from this lesion/these lesions (TIL expansion). The transplant product will be produced in the Good Manufacturing Practice (GMP) facility of the University Hospital in Basel. TIL transfer to patient and first administration of ANV419 at day 0.
Receives: Drug: Combination of Tumor-infiltrating lymphocyte transfer with ANV419

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events (%)

    Incidence of adverse events (%) will be recorded to assess safety of combination of Tumor-infiltrating lymphocytes with ANV419

    Measured: up to one year after TIL transfer

  2. Frequency of adverse events (number)

    Frequency of adverse events (number) will be recorded to assess safety of combination of Tumor-infiltrating lymphocytes with ANV419

    Measured: up to one year after TIL transfer

  3. Severity of adverse events (CTCAE v5.0 criteria)

    Severity of adverse events (CTCAE v5.0 criteria) will be recorded to assess safety of combination of Tumor-infiltrating lymphocytes with ANV419.

    CTCAE (Common Terminology Criteria for Adverse Events): Grade 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = fatal.

    Measured: up to one year after TIL transfer

Secondary outcomes (4)

  1. Objective Response Rate (ORR)

    ORR is defined as the proportion of patients with a best overall response of partial response or better (assessed by the local investigators)

    Measured: up to one year after TIL transfer

  2. Duration of response (DOR)

    DOR is 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. DOR time for responders who have not progressed or died will be censored at the time of last tumor assessment

    Measured: up to one year after TIL transfer

  3. Progression-fee Survival (PFS)

    The progression-free survival (PFS) is defined as the time from registration to objective tumor progression (determined by local investigators), or death due to any cause, whichever occurred first. PFS time for patients who have not progressed or died will be censored at the time of the last tumor assessment

    Measured: up to one year after TIL transfer

  4. Overall survival (OS)

    OS is defined as the time from registration to the date of death due to any cause

    Measured: up to one year after TIL transfer

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2023
  2. Study start21 Jun 2023
  3. Primary completionApr 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

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
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05869539
Sponsor's protocol ID
2023-00575, th23laeubli
Other IDs
2023
Acronym
BaseTIL-03M
Status last verified
Feb 2026
First submitted
11 May 2023
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Combination of Tumor-infiltrating lymphocyte transfer with ANV419 in people with Advanced Melanoma, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

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 11 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (%) (time frame: up to one year after TIL transfer). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05869539.

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 27 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in