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.
Who Can Participate?
Eligibility
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 Range
18-100
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
Yes
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
Melodi
Whitley
Protocol Number
PRO00119221
Phase
II
Enrollment Status
Pending Open to Enrollment