Great progress has been made in the treatment of patients with advanced melanoma over the past few years. However, the therapy options are limited if the condition continues to advance despite drug immunotherapy. For patients with advanced soft tissue sarcoma, the options are still limited to chemotherapy. Therefore, more treatment options are urgently required for these two patient groups.

The SAKK 66/17 trial will investigate a treatment approach that promises a therapeutic benefit if immunotherapy and chemotherapy are no longer effective: the thermal removal of a tumor nodule followed by injection of the substance IP-001 into the tumor. IP-001 is a medication that stimulates the body’s own defense system and is not currently approved. This approach aims to stimulate the immune system in order to shrink the tumor that has undergone treatment. It is also hoped that a farther-reaching immune response will be triggered which will also target cancer cells located some distance away from the tumor nodule treated.

Focus on safety and efficacy

The trial is divided into two phases:

• The first part will examine the safety of the approach in 6 patients and set the dosage of IP-001 for the second part of the trial.
• In the second part, further safety data and initial information on efficacy will be collected. Nine patients with advanced soft tissue sarcoma and 18 patients with advanced melanoma will be treated. The IP-001 dosage adopted will be the one that was assessed as safe in the first part of the trial.

In addition, blood and tumor tissue samples from the patients treated will be analyzed in more detail as part of the trial. The aim here is to better understand the immune response and the therapy's mechanism of action.