Study on L19IL2, L19TNF, or L19IL2/TNF for Patients with Basal Cell Carcinoma (BCC)
Sponsor: Philogen S.p.A.
ClinicalTrials ID:NCT07227350
This clinical trial is testing new treatments for patients with locally advanced Basal Cell Carcinoma (BCC) who cannot or choose not to have surgery or radiation. The study aims to evaluate the effectiveness and safety of three different treatment options involving L19IL2 and L19TNF.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study is exploring the effectiveness of three different treatments for patients with locally advanced Basal Cell Carcinoma (BCC) who are not eligible for or refuse surgery or radiation. The treatments involve injections of L19IL2, L19TNF, or a combination of both directly into the tumor. The study will include 60 to 180 patients, who will be randomly assigned to one of the three treatment groups. Each patient will receive weekly injections for four weeks, and any new tumors that appear during this time will also be treated. Patients will be monitored for up to three years to assess the treatment's effectiveness and safety.
Description
Patients in this study will receive injections directly into their tumors once a week for four weeks. The treatments being tested are L19IL2, L19TNF, or a combination of both. After the treatment period, doctors will check the tumors at regular intervals to see if they have shrunk or disappeared. These checks will happen at 8, 12, and 16 weeks after starting treatment, and then every 8 weeks for the first year. In the second and third years, checks will be every 12 weeks. If the tumors respond well, surgery might be considered to remove any remaining cancer. Patients will be followed for overall survival and any further treatments they receive will be recorded. The study aims to find out if these treatments can effectively control BCC and improve patient outcomes.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 to 100 with locally advanced Basal Cell Carcinoma (BCC) that cannot be treated with surgery or radiation.
- Must have at least one tumor that can be injected and measured.
- No previous treatment with checkpoint inhibitors.
- May have had previous surgery or radiation, but the cancer must have progressed if previously treated with radiation.
- Must be in good general health with specific blood test results within normal ranges.
- Women of childbearing potential must use effective contraception and have a negative pregnancy test.
- Men must agree to use contraception if their partners are of childbearing potential.
- Willing to follow the study schedule and procedures.
Exclusion Criteria
- Have another type of cancer, unless it was treated more than 3 years ago and is not life-threatening.
- Have had radiation therapy on the tumor sites within 4 weeks before starting the study.
- Currently receiving chemotherapy, targeted therapy, or immunotherapy.
- Have active infections or other serious health conditions.
- Have a history of severe heart problems or uncontrolled high blood pressure.
- Have severe liver or kidney problems.
- Have an autoimmune disease requiring treatment in the past 2 years.
- Are pregnant or breastfeeding.
- Have received a live vaccine within 30 days before starting the study.
- Any condition that might interfere with the study or the patient's ability to participate.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc. | 33612 | Tampa | Florida |
| Winship Cancer Institute, Emory University | 30322 | Atlanta | Georgia |
| The University of Texas MD Anderson Cancer Center | 77030 | Houston | Texas |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.