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L19IL2/L19TNF in patients with non-melanoma skin cancer.
EU CTIS ID: 2024-518530-92-00
What this study is testing
Confirmed Best Overall Response Rate (BORR) [Complete Response (CR) + Partial Response (PR)] for BCC tumor type measured according to RECIST v1.1 criteria. Confirmation of CR requires histopathological analysis of exeresis specimens for lesions removed by surgery or of biopsies in all other cases.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Patients with high-risk, locally advanced (non-metastatic, node negative, single or multifocal), basal cell carcinoma (BCC) or cutaneous squamous cell carcinoma (cSCC) amenable to intratumoral injection, not eligible to surgery or radiation therapy according to the evaluation of a local interdisciplinary tumor board or who refuse surgery or radiation therapy and for whom an histological evaluation is available according to international guidelines. Eligible patients are those as defined by the European Association of Dermato-Oncology (EADO) operational staging system (stages IIa to IIIb) [1] for BCC and by EADO/EORTC (European Organization for Research and Treatment of Cancer) interdisciplinary guidelines [1] for cSCC.
- 10. 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.
- 11. 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.
- 12. Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
- 2. Patients with injectable and measurable regional cutaneous or subcutaneous in-transit or satellite metastasis but without regional nodal involvement are also eligible.
- 3. Male or female patients, age 18 - 100 years.
You likely can't join if
- 1. Previous or concurrent cancer type that is distinct from the cancers being evaluated in this study, except any cancer curatively treated more than 2 years prior to study entry.
- 10. Known uncontrolled coagulopathy or bleeding disorder.
- 11. Known hepatic cirrhosis or severe pre-existing hepatic impairment.
- 12. Moderate to severe respiratory failure.
- 13. Active autoimmune disease.
- 14. Patient requires or is taking systemic corticosteroids (>5 mg/day) or other immunosuppressant drugs on a long-term basis. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions and asthma/COPD is not considered an exclusion criterion.
See the full eligibility criteria
Who can join
- 1. Patients with high-risk, locally advanced (non-metastatic, node negative, single or multifocal), basal cell carcinoma (BCC) or cutaneous squamous cell carcinoma (cSCC) amenable to intratumoral injection, not eligible to surgery or radiation therapy according to the evaluation of a local interdisciplinary tumor board or who refuse surgery or radiation therapy and for whom an histological evaluation is available according to international guidelines. Eligible patients are those as defined by the European Association of Dermato-Oncology (EADO) operational staging system (stages IIa to IIIb) [1] for BCC and by EADO/EORTC (European Organization for Research and Treatment of Cancer) interdisciplinary guidelines [1] for cSCC.
- 10. 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.
- 11. 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.
- 12. Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
- 2. Patients with injectable and measurable regional cutaneous or subcutaneous in-transit or satellite metastasis but without regional nodal involvement are also eligible.
- 3. Male or female patients, age 18 - 100 years.
- 4. ECOG Performance Status/WHO Performance Status ≤ 1.
- 5. Hemoglobin > 10.0 g/dL
- 6. Platelets > 100 x 109/L.
- 7. ALT and AST, GGT and Lipase ≤ 1.5 x the upper limit of normal (ULN).
- 8. Serum creatinine < 1.5 x ULNAn age-calibrated definition of CKD has been proposed to distinguish age-related from disease-related changes in eGFR. For patients younger than 40 years, CKD is defined by eGFR below 75 mL/min/1.73m2. For patients with ages between 40 and 65 years, CKD is defined by 60 mL/min/1.73m2. For subjects older than 65 years without albuminuria or proteinuria, CKD is defined by eGFR below 45 mL/min/1.73m2.
- 9. 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.
What rules you out
- 1. Previous or concurrent cancer type that is distinct from the cancers being evaluated in this study, except any cancer curatively treated more than 2 years prior to study entry.
- 10. Known uncontrolled coagulopathy or bleeding disorder.
- 11. Known hepatic cirrhosis or severe pre-existing hepatic impairment.
- 12. Moderate to severe respiratory failure.
- 13. Active autoimmune disease.
- 14. Patient requires or is taking systemic corticosteroids (>5 mg/day) or other immunosuppressant drugs on a long-term basis. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions and asthma/COPD is not considered an exclusion criterion.
- 15. Known history of allergy to IL2, TNF, or other human proteins/peptides/antibodies.
- 16. Pregnancy or breast-feeding.
- 17. Ischemic peripheral vascular disease (Grade IIb-IV).
- 18. Severe diabetic retinopathy.
- 19. Recovery from major trauma including surgery within 4 weeks prior to enrollment.
- 2. Topical or systemic chemotherapy, immunotherapy or radiation therapy on the tumor sites in the 4 weeks prior to study drug administration.
- 20. Solid organ transplant recipient or patient with iatrogenic or pathologic severe immune suppression.
- 21. Any conditions that in the opinion of the investigator could hamper compliance with the study protocol.
- 3. Patients with node positive BCC/cSCC who are candidate to SHH inhibitor or checkpoint inhibitor therapy.
- 4. Presence of active severe bacterial or viral infections or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study. In particular a documented test for HIV, HBV and HCV excluding active infection is needed.
- 5. History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris, of inadequately treated cardiac arrhythmias and heart insufficiency (any grade, New York Heart Association (NYHA) criteria).
- 6. Any abnormalities observed during baseline ECG investigations that are considered as clinically significant by the investigator.
- 7. Known arterial aneurysms.
- 8. INR > 3.
- 9. Uncontrolled hypertension.
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.