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New treatment option for Locally Advanced Basal Cell Carcinoma
Official title L19IL2 or L19TNF or L19IL2/TNF in Patients With Basal Cell Carcinoma (BCC)
ClinicalTrials.gov ID: NCT07227350
What this study is testing
What is L19IL2?
L19IL2 is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for locally advanced basal cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Open label, randomized study in patients with LaBCC not eligible or refusing surgery or radiation therapy according to the evaluation of a local interdisciplinary tumor board. The primary objective of the study is to evaluate the efficacy of L19IL2 or L19TNF or L19IL2/L19TNF, the secondary objectives of this study are to evaluate efficacy, safety and pharmacokinetics of immunocytokines.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 4 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- Patients with high risk, locally advanced histologically confirmed (non-metastatic, node negative, single or multifocal), BCC and amenable to...
- Patients with at least one injectable and measurable cutaneous or subcutaneous lesion.
- Patients must not have received prior HHIs and checkpoint inhibitors systemic treatment.
- Patients may have received prior surgery and/or radiation therapy.
- Radiotherapy must have been previously administered for their locally advanced BCC, unless radiotherapy is contraindicated or inappropriate (e.g...
You likely can't join if
- 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...
- Current topical or systemic chemotherapy, targeted therapy immunotherapy.
- Patients with node positive BCC who are candidates for checkpoint inhibitor therapy.
- Presence of active severe bacterial or viral infections or other severe concurrent disease/infection requiring therapy, including positive tests for...
- History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris...
- Any abnormalities observed during baseline ECG investigations that are considered clinically significant by the investigator.
See the full eligibility criteria
Who can join
- Patients with high risk, locally advanced histologically confirmed (non-metastatic, node negative, single or multifocal), BCC and amenable to intratumoral injection, not eligible or refusing surgery or radiation therapy...
- Patients with at least one injectable and measurable cutaneous or subcutaneous lesion.
- Patients must not have received prior HHIs and checkpoint inhibitors systemic treatment.
- Patients may have received prior surgery and/or radiation therapy.
- Radiotherapy must have been previously administered for their locally advanced BCC, unless radiotherapy is contraindicated or inappropriate (e.g., hypersensitivity to radiation due to genetic syndrome such as Gorlin...
- Patients must have a histologically confirmed disease that is considered to be inoperable or medical contraindication to surgery or radiotherapy, in the opinion of a Mohs dermatologic surgeon, head and neck surgeon...
- BCC that has recurred in the same location after two or more surgical procedures and curative resection is deemed unlikely
- Anticipated substantial morbidity and/or deformity from surgery (e.g., removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation);
- Medical conditions predisposing to poor surgical outcome (e.g., diabetes with history of poor wound healing);
- Other conditions considered to be medically contraindicating must be discussed with the Medical Monitor before enrolling the patient.
- Prior radiotherapy to the target lesions must be completed at least 4 weeks prior to first study drug administration, with all acute RT-related toxicities resolved to ≤ Grade 1.
- Male or female patients, who are capable of giving consent, age ≥ 18 years.
- ECOG Performance Status/WHO Performance Status ≤ 1.
- 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...
- 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...
- Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
What rules you out
- 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...
- Current topical or systemic chemotherapy, targeted therapy immunotherapy.
- Patients with node positive BCC who are candidates for checkpoint inhibitor therapy.
- Presence of active severe bacterial or viral infections or other severe concurrent disease/infection requiring therapy, including positive tests for human immunodeficiency virus (HIV)-1 or HIV-2 serum antibody...
- 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...
- Any abnormalities observed during baseline ECG investigations that are considered clinically significant by the investigator.
- 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.
- Known arterial aneurysms.
- 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...
- 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...
- 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...
- Any conditions that in the opinion of the investigator could hamper compliance with the study protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States; Atlanta, Georgia, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.