Locally Advanced Basal Cell CarcinomaPhase 2NCT07227350
L19IL2 or L19TNF or L19IL2/TNF in Patients With Basal Cell Carcinoma (BCC)
A Phase 2 study testing L19IL2, L19TNF and L19IL2/L19TNF in people with Locally Advanced Basal Cell Carcinoma, run by Philogen S.p.A. at 18 sites in 5 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Basal Cell Carcinoma
- What is being tested?
- L19IL2, L19TNF and L19IL2/L19TNF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 18 sitesin 5 countries
- Study dates
- 1 Jun 2026to Feb 2031
- Phase
- Phase 2
- 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 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 according to the evaluation of a local interdisciplinary tumor board.
- 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 syndrome, limitations because of location of tumor, or cumulative prior radiotherapy dose). For patients whose locally advanced BCC has been irradiated, disease must have progressed after radiation.
- 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, plastic surgeon or surgical/medical oncologist. Acceptable medical contraindications to surgery include:
Show all 20Show fewer
- 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 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, vasectomized 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.
Who cannot join
- 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 squamous-cell carcinoma of the skin (surgically removed 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.
- Current topical or systemic chemotherapy, targeted therapy immunotherapy.
- Patients with node positive BCC who are candidates for checkpoint inhibitor therapy.
- 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.
- 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, 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).
Show all 24Show fewer
- Any abnormalities observed during baseline ECG investigations that are considered clinically significant by the investigator.
- 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 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.
Trial locations and contacts
18 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 5 countries
United States6 sites, 6 recruiting
- Recruiting
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
Michael C. Lowe, MD
- Not yet recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Luke D. Rothermel, MD
- Not yet recruiting
The Ohio State University Wexner Medical Center Clinical Laboratories
Columbus, Ohio, 43210
Carlo Contreras, MD
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Melodi J Whitley, MD
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Michael R Migden, MD
- Recruiting
H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.
Tampa, Florida, 33612
Jonathan S Zager, MD
Germany6 sites, 6 recruiting
- Recruiting
Universitaetsklinikum Augsburg
Augsburg, 86179
Julia Welzel, Prof.
- Recruiting
Charite Universitaetsmedizin Berlin KöR
Berlin, 10117
Thomas Eigentler, Prof.
- Recruiting
Universitaetsklinikum Essen AöR
Essen, 45147
Dirk Schadendorf, Prof.
- Recruiting
Universitaetsklinikum Halle (Saale) AöR
Halle, 06120
Johannes Wohlrab
- Recruiting
Universitaetsklinikum Schleswig-Holstein AöR
Kiel, 24105
Katharina Kahler
- Recruiting
Universitaetsklinikum Tuebingen AöR
Tübingen, 72076
Lukas Flatz, Prof.
Italy4 sites, 4 recruiting
- Recruiting
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Naples, 80131
Paolo Ascierto, Prof.
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Ketty Peris, Prof.
- Recruiting
Humanitas Mirasole S.p.A.
Rozzano, 20089
Paolo Bossi, Prof.
- Recruiting
Azienda Ospedaliero-Universitaria Senese
Siena, 53100
Annamaria Di Giacomo, Prof.
Greece1 site, 1 recruiting
- Not yet recruiting
Andreas Syngros Hospital Of Venereal And Dermatological Diseases
Athens, 16121
Alexandros Stratigos, Prof.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic De Barcelona
Barcelona, 08036
Agustin Toll Abello, Prof.
About this study
Official title: A Phase 2 Controlled Randomized Study of the Efficacy of L19IL2 or L19TNF or L19IL2/L19TNF Intralesional Injections for the Treatment of Locally Advanced Basal Cell Carcinoma (LaBCC)
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. A minimum of 60 patients and a maximum of 180 evaluable patients will be randomized in a 1:1:1 ratio to one of the three different treatment arms of the study and will receive intralesional injections of: (i) Monotherapy 13 Mio IU (~2.17 mg) L19IL2; or (ii) Monotherapy 0.4 mg L19TNF; or (iii) Combination of 13 Mio IU L19IL2 + 0.4 mg L19TNF, once weekly for 4 consecutive weeks. Patients will be followed for a maximum of 156 weeks after beginning of treatment.
Read the detailed description
Tumor Assessment (TA) visits will be performed at Week 8 (Day 50 from the beginning of treatment), Week 12 (Day 78), Week 16 (Day 106) and then every 8 weeks for the first year of Follow-up (FU). During second and third years of FU, TA visits will be performed every 12 Weeks. In case a response (CR, PR) or stable disease (SD) is observed, a confirmatory assessment of the tumor response will be performed 4 weeks after the TA visit, when the objective response was first recorded.
Tumor response shall be evaluated according to composite criteria, i.e. BCC-RECIST-like. Measurement of tumor lesions and documentation (photographic documentation with use of a caliper for cutaneous lesions; ultrasound for subcutaneous lesions; imaging techniques as MRI) will be performed at every TA visit.
Confirmation of response or stable disease will be assessed by histopathological analysis of specimens from the treated skin area by multiple punch biopsies. Confirmation of tumor responses will be centrally reviewed by an independent committee (Independent Central Review, ICR).
After the TA visit confirmatory of partial response or stable disease, surgery with a curative intention can be performed if considered appropriate in the judgement of the investigator and if agreed upon by the patient; in these cases, pathological response in the exeresis specimen(s) will be evaluated as described above.
Patients will be followed for overall survival (OS) after a relapse or progression, and any further treatment given will be recorded for three years. Phone contact or any other documented contact with the patient will be recorded every 6 months for OS assessment from treatment start until the death of the patient, withdrawal of consent or until study completion (LPLV).
L19IL2 or L19TNF or L19IL2/L19TNF will be administered to eligible patients under the supervision of the investigator or identified sub-investigator(s). Patients will receive intratumoral administrations of immunocytokines into injectable cutaneous, and subcutaneous tumors once weekly for up to 4 weeks.
On the day of each treatment visit, all tumors to be injected should be measured and recorded (using caliper/ruler for cutaneous lesions and/or ultrasound for subcutaneous lesions). The recommended volume to be injected into the tumor(s) is dependent on the size of the lesion(s). The maximum dose to be administered in a single treatment visit is:
- 13 MioIU L19IL2, or ii) 0.4 mg L19TNF or iii) 13 MioIU L19IL2 + 0.4 mg L19TNF It is recommended that each lesion should receive the maximum amount possible to inject due to tumor properties at each visit.
- Conditions
- Locally Advanced Basal Cell Carcinoma
- Being tested
- L19IL2, L19TNF, L19IL2/L19TNF
- Keywords
- Basal Cell Carcinoma, locally advanced, subcutaneous lesions, cutaneous lesions
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L19IL2Drug
Intratumoral injections
L19TNFDrug
Intratumoral injections
L19IL2/L19TNFDrug
Intratumoral injections
| Study group | Role | What they receive |
|---|---|---|
| L19IL2 | Experimental | Patient will receive intralesional injections of monotherapy 13 Mio IU (~2.17 mg) L19IL2. Frequency and duration are identical for all arms. Receives: Drug: L19IL2 |
| L19IL2/L19TNF | Experimental | Patient will receive intralesional injections of Combination of 13 Mio IU L19IL2 + 0.4 mg L19TNF. Frequency and duration are identical for all arms. Receives: Drug: L19IL2/L19TNF |
| L19TNF | Experimental | Patient will receive intralesional injections of monotherapy 0.4 mg L19TNF. Frequency and duration are identical for all arms. Receives: Drug: L19TNF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Overall Response Rate
Confirmed Best Overall Response Rate per BCC-RECIST-like criteria according to ICR by Week 16.
Measured: from enrollment to week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2025
- Study start1 Jun 2026
- Primary completionFeb 2031 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Basal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Philogen S.p.A.The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philogen S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227350
- Sponsor's protocol ID
- PH-L19IL2TNFCOMB-04/24
- Other IDs
- 2025-523229-16-00, 2025
- Status last verified
- Jul 2026
- First submitted
- 7 Nov 2025
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Controlled Randomized Study of the Efficacy of L19IL2 or L19TNF or L19IL2/L19TNF Intralesional Injections for the Treatment of Locally Advanced Basal Cell Carcinoma (LaBCC)
- ClinicalTrials.gov ID
- NCT07227350
- Acronym / sponsor ID
- PH-L19IL2TNFCOMB-04/24
- Conditions
- Locally Advanced Basal Cell Carcinoma
- Keywords
- Basal Cell Carcinoma, locally advanced, subcutaneous lesions, cutaneous lesions
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Philogen S.p.A.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Feb 2031 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 12 Nov 2025 (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.
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. A minimum of 60 patients and a maximum of 180 evaluable patients will be randomized in a 1:1:1 ratio to one of the three different treatment arms of the study and will receive intralesional injections of: (i) Monotherapy 13 Mio IU (~2.17 mg) L19IL2; or (ii) Monotherapy 0.4 mg L19TNF; or (iii) Combination of 13 Mio IU L19IL2 + 0.4 mg L19TNF, once weekly for 4 consecutive weeks. Patients will be followed for a maximum of 156 weeks after beginning of treatment.
Detailed description
Tumor Assessment (TA) visits will be performed at Week 8 (Day 50 from the beginning of treatment), Week 12 (Day 78), Week 16 (Day 106) and then every 8 weeks for the first year of Follow-up (FU). During second and third years of FU, TA visits will be performed every 12 Weeks. In case a response (CR, PR) or stable disease (SD) is observed, a confirmatory assessment of the tumor response will be performed 4 weeks after the TA visit, when the objective response was first recorded.
Tumor response shall be evaluated according to composite criteria, i.e. BCC-RECIST-like. Measurement of tumor lesions and documentation (photographic documentation with use of a caliper for cutaneous lesions; ultrasound for subcutaneous lesions; imaging techniques as MRI) will be performed at every TA visit.
Confirmation of response or stable disease will be assessed by histopathological analysis of specimens from the treated skin area by multiple punch biopsies. Confirmation of tumor responses will be centrally reviewed by an independent committee (Independent Central Review, ICR).
After the TA visit confirmatory of partial response or stable disease, surgery with a curative intention can be performed if considered appropriate in the judgement of the investigator and if agreed upon by the patient; in these cases, pathological response in the exeresis specimen(s) will be evaluated as described above.
Patients will be followed for overall survival (OS) after a relapse or progression, and any further treatment given will be recorded for three years. Phone contact or any other documented contact with the patient will be recorded every 6 months for OS assessment from treatment start until the death of the patient, withdrawal of consent or until study completion (LPLV).
L19IL2 or L19TNF or L19IL2/L19TNF will be administered to eligible patients under the supervision of the investigator or identified sub-investigator(s). Patients will receive intratumoral administrations of immunocytokines into injectable cutaneous, and subcutaneous tumors once weekly for up to 4 weeks.
On the day of each treatment visit, all tumors to be injected should be measured and recorded (using caliper/ruler for cutaneous lesions and/or ultrasound for subcutaneous lesions). The recommended volume to be injected into the tumor(s) is dependent on the size of the lesion(s). The maximum dose to be administered in a single treatment visit is:
- 13 MioIU L19IL2, or ii) 0.4 mg L19TNF or iii) 13 MioIU L19IL2 + 0.4 mg L19TNF It is recommended that each lesion should receive the maximum amount possible to inject due to tumor properties at each visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| L19IL2 | Experimental | Drug: L19IL2Patient will receive intralesional injections of monotherapy 13 Mio IU (~2.17 mg) L19IL2. Frequency and duration are identical for all arms. |
| L19IL2/L19TNF | Experimental | Drug: L19IL2/L19TNFPatient will receive intralesional injections of Combination of 13 Mio IU L19IL2 + 0.4 mg L19TNF. Frequency and duration are identical for all arms. |
| L19TNF | Experimental | Drug: L19TNFPatient will receive intralesional injections of monotherapy 0.4 mg L19TNF. Frequency and duration are identical for all arms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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 according to the evaluation of a local interdisciplinary tumor board.
- 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 syndrome, limitations because of location of tumor, or cumulative prior radiotherapy dose). For patients whose locally advanced BCC has been irradiated, disease must have progressed after radiation.
Key exclusion criteria (24 listed)
- 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 squamous-cell carcinoma of the skin (surgically removed 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.
- Current topical or systemic chemotherapy, targeted therapy immunotherapy.
- Patients with node positive BCC who are candidates for checkpoint inhibitor therapy.
- 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.
- 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, 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.
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 |
|---|---|---|
| L19IL2Intratumoral injections | Drug | L19IL2 |
| L19TNFIntratumoral injections | Drug | L19TNF |
| L19IL2/L19TNFIntratumoral injections | Drug | L19IL2/L19TNF |
Primary outcome
Best Overall Response Rate
Time frame: from enrollment to week 16
Confirmed Best Overall Response Rate per BCC-RECIST-like criteria according to ICR by Week 16.
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 31 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Locally Advanced Basal Cell Carcinoma
Not yet recruitingPhase 2
A Study Comparing Cemiplimab-based Treatments for Adult Participants With Locally Advanced Basal Cell Skin Cancer (laBCC)
Locally Advanced Basal Cell Carcinoma
Active, not recruitingPhase 2
Enzalutamide for Patients With Androgen Receptor Positive Salivary Cancers
Androgen Receptor Positive, Locally Advanced Salivary Gland Carcinoma
RecruitingPhase 1/2
A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors
Advanced Solid Tumors, Genital Neoplasm, Female
RecruitingPhase 2
L19IL2/TNF in Patients With Basal Cell Carcinoma
Locally Advanced Basal Cell Carcinoma
Active, not recruitingPhase 3
Study Comparing the Standard Administration of IO Versus the Same IO Administered Each 3 Months in Patients in Response After 6 Months of Standard IO
Lung Cancer Metastatic, Renal Cell Carcinoma
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.
18 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing L19IL2, L19TNF and L19IL2/L19TNF in people with Locally Advanced Basal Cell Carcinoma, run by Philogen S.p.A. at 18 sites in 5 countries.
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 20 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Germany, Italy, Greece, Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Lisa Nadal (05771526723, lisa.nadal@philogen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Overall Response Rate (time frame: from enrollment to week 16). 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 31 Jul 2026.