This trial is looking at the effectiveness, safety, and tolerability of ladiratuzumabvedotin (LV) in patients with advanced solid tumors, including melanoma. The main outcome to be measured in this trial is the response rate to the new drug.
Advanced tumors have spread from the organ where they originated. These tumors are often hard to treat with standard treatments. New therapies are needed for these tumors. Immune therapies such as antibody-drug conjugates (ADC) have shown promise in treating advanced cancers. ADCs are empowered antibodies that target tumors and release cell-killing agents. LV is an experimental ADC.
This trial is evaluating the safety and effectiveness of LV in the treatment of advanced cancers including melanoma. The main outcomes that will be measured will be the response rate.
Who are they looking for?
This trial is aiming to include 264 patients with advanced tumors including melanoma. Patients must have a skin melanoma that cannot be surgically removed and that has progressed after immunotherapy.
Patients will be excluded if they have had another cancer within the past 3-years, any anti-cancer treatment within 3-weeks of starting the trial, known brain disease, or active infections that have required treatment with 7-days of starting the first dose of LV. Radiotherapy within 2 weeks and a live vaccine within a month of this trial will be also excluded.
How will it work
There will be one group in this trial. All participants will receive LV as an intravenous (into the vein) infusion. Response rate, side effects, and survival will be monitored for up to 1 year.