Full Title
A phase 2, three-arm, randomized study of the efficacy of intratumorally administered L19IL2 or L19TNF or L19IL2/L19TNF, all in combination with systemic anti-PD1 pembrolizumab, in stage III and IV unresectable melanoma patients with resistance to or progressing upon anti-PD1 checkpoint inhibitors and with presence of injectable metastases (INTACT / MeRCI)Purpose
Researchers want to learn if L19IL2 and L19TNF, alone or together, work well to treat melanoma when given with pembrolizumab. The people in this study have melanoma that has metastasized (spread) or is inoperable (cannot be taken out with surgery). Their cancers keep growing even after having immune-boosting therapy.
L19IL2 and L19TNF are called immunocytokines, which means they work with your immune system to destroy cancer cells. These drugs bind to tumors, killing cancer cells and activating the immune system to stop and slow tumor growth. Both drugs are injected directly into a tumor. Pembrolizumab is a standard immunotherapy for melanoma and is given intravenously (by vein).
If you join this study, you will get one of these treatments in addition to pembrolizumab:
- L19IL2
- L19TNF
- L19IL2 and L19TNF together
Who Can Join
To join this study, there are a few conditions. You must:
- Have metastatic or inoperable melanoma that keeps growing after immunotherapy.
- Have recovered from the serious side effects of prior treatments before getting the study therapy.
- Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
- Be age 18 or older.
Contact
For more information or to see if you can join this study, please call Dr. Danielle Bello’s office at 646-888-4945.