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L19IL2/L19TNF for Locally Advanced Cutaneous Squamous Cell Carcinoma

This study is testing a treatment called L19IL2/L19TNF for people with locally advanced cutaneous squamous cell carcinoma (a type of skin cancer) that has either worsened or couldn't tolerate previous immune checkpoint inhibitor (ICI) treatment. The treatment involves injecting L19IL2/L19TNF directly into your tumors. Researchers want to see how many people respond to this treatment. The study is open to adults aged 18 and older. The treatment works by targeting a 'checkpoint inhibitor' mechanism, which helps the body's immune system fight cancer. The study aims to enroll 92 participants, but its current status is unclear.

Study design
This is an open-label, single-arm study, meaning all participants receive the same treatment and everyone knows what treatment is being given. It plans to enroll 92 participants.
What's involved
You would receive weekly injections of L19IL2/L19TNF into your tumors for up to 4 weeks, with a possible second 4-week course. Tumor assessments will occur at weeks 8, 12, then every 8 weeks for the first year, and every 12 weeks for the second and third years.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for overall survival after relapse or progression, with phone or other contact every 6 months until death, withdrawal, or study completion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07228442

L19IL2/L19TNF in Patients With Cutaneous Squamous Cell Carcinoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
Philogen S.p.A.
~92 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:L19IL2/L19TNF

At a glance

Recruiting sites
17 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Response Rate (BORR)
Measured over From enrollment up to a maximum of 160 weeks after the start of treatment

Conditions

Locally Advanced Cutaneous Squamous Cell Carcinoma

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Skin Squamous Cell Carcinoma

NCT07228442

Where you'd take part

This study runs at 19 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Andreas Syngros Hospital Of Venereal And Dermatological Diseases

    Athens, Greeceno site contact published

    Not yet recruiting

  • Azienda Ospedaliero-Universitaria Senese

    Siena, Italyno site contact published

    Recruiting

  • Charite Universitaetsmedizin Berlin KöR

    Berlin, Germanyno site contact published

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusettsno site contact published

    Recruiting

  • Duke University Medical Center

    Durham, North Carolinano site contact published

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, Italyno site contact published

    Recruiting

  • Hospital Clinic De Barcelona

    Barcelona, Spainno site contact published

    Recruiting

  • Humanitas Mirasole S.p.A.

    Rozzano, Italyno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Lisa Nadal
[email protected]
+3905771526723
Email the study team

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Eligibility criteria

Inclusion

Patients must have histologically documented, locally advanced cSCC.
Patients must have at least one injectable and measurable cutaneous or subcutaneous lesion.
Patients must have locally advanced cSCC that has progressed on or cannot tolerate ICI treatment (adjuvant or first line) as assessed by a local multidisciplinary tumor board.
Patients with nodal, regional or in transit injectable cSCC lesions.
Patients must be willing to provide tissue from a core or excisional biopsy of a tumor lesion at screening and for confirmation of Objective Response or Stable Disease.
Male or female patients, who are capable of giving consent, age ≥ 18 years.
ECOG Performance Status/WHO Performance Status ≤ 2.
Hemoglobin \> 10.0 g/dL.
Platelets \> 100 x 109/L.
ALT and AST, GGT and Lipase ≤ 1.5 x the upper limit of normal (ULN).
All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v. 5.0) Grade ≤ 1 unless otherwise specified.
Women of childbearing potential (WOCBP) must have negative pregnancy test results at screening. WOCBP must be using, from screening to three months following the last study drug administration, highly effective contraception methods, as defined by the "Recommendations for contraception and pregnancy testing in clinical trials" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, vasectomised partner.
Male patients with WOCBP partners must agree to use simultaneously two acceptable methods of contraception (i.e. spermicidal gel plus condom) from the screening to three months following the last study drug administration.
Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.

Exclusion

Presence of concomitant malignancies, with the exception of any cancer curatively treated more than 3 years prior to study entry and of tumors with a negligible risk for metastasis or death, such as adequately treated basal cell carcinoma of the skin (surgically removed at least 4 weeks prior to study entry), ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix, early-stage asymptomatic CLL and not under active treatment (Rai 0, Binet A) will be eligible for the study.
Radiation therapy on the tumor sites in the 4 weeks prior to study drug administration.
Current topical or systemic chemotherapy, immunotherapy.
Presence of visceral metastasis.
disease/infection requiring therapy, including positive tests for human immunodeficiency virus (HIV)-1 or HIV-2 serum antibody, hepatitis B virus (HBV), or hepatitis C virus (HCV). For HBV serology, the determination of HBsAg and anti-HBcAg Ab is required. In patients with serology documenting previous exposure to HBV, negative serum HBV-DNA is required. For HCV, HCV-RNA or HCV antibody test is required. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no current infection are eligible.
History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris, inadequately treated cardiac arrhythmias and heart insufficiency (any grade, New York Heart Association (NYHA) criteria).
Any abnormalities observed during baseline ECG investigations that are considered clinically significant by the investigator.
Known arterial aneurysms.
Chronically impaired renal function as indicated by creatinine clearance \< 60 mL/min/1.73m2 or for patients older than 65 years without albuminuria or proteinuria, creatinine clearance \< 45 mL/min/1.73m2.
INR \> 3.
Uncontrolled hypertension.
Known uncontrolled coagulopathy or bleeding disorder.
Known hepatic cirrhosis or severe pre-existing hepatic impairment.
Moderate to severe respiratory failure.
Active autoimmune disease that has required systemic treatment in past 2 years.
Patients have a diagnosis of immunodeficiency or are receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions and asthma/COPD is not considered an exclusion criterion.
Known history of allergy to IL2, TNF, or other human proteins/peptides/antibodies.
Pregnancy or breast-feeding.
Ischemic peripheral vascular disease (Grade IIb-IV).
Severe diabetic retinopathy.
Recovery from major trauma including surgery within 4 weeks prior to enrollment.
Solid organ transplant recipient or patient with iatrogenic or pathologic severe immune suppression.
Patients with a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
Patients who have received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
Any conditions that in the opinion of the investigator could hamper compliance with the study protocol.

What this trial measures

  • Overall Response Rate (BORR)From enrollment up to a maximum of 160 weeks after the start of treatment

    Best Overall Response Rate (BORR) as defined by the RECIST 1.1. criteria according to an Independent Central Review (ICR).