PH-L19IL2TNFCOMB

What is the Purpose of this Study?

People in this study will be placed into one of three groups. They will receive either L19IL2, L19TNF, or both L19IL2 and L19TNF. These treatments are given once a week for up to 4 weeks, or until the person’s tumors are gone.

What is the Condition Being Studied?

Advanced basal cell carcinoma

Who Can Participate in the Study?

People can join this study if they have at least one tumor on or under the skin that can be measured and injected with the study medicine. They must have a type of skin cancer called Basal Cell Carcinoma that is high risk and has not spread. Their cancer must be confirmed by a lab test and able to be treated with injections. They can join if surgery or radiation is not a good option for them or if they choose not to have those treatments, based on the decision of a group of doctors who review their case.

Age Group
Adults

What is Involved?

This study wants to find out how well the medicines L19IL2, L19TNF, and the combination of both work for people with Basal Cell Carcinoma. Researchers also want to see how well people tolerate these medicines and whether the combination helps patients live longer. People can join if they have not taken checkpoint inhibitor treatments before. They may have had surgery or radiation in the past.

Study Details

Full 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 patients
Principal Investigator
Assistant Professor of Dermatology
Protocol Number
IRB: PRO00119221
NCT: NCT07227350
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
INSTITUTIONAL APPROVAL SIGNOFF