In short
Clinical trials are investigating Ltx-315 in people with advanced melanoma, especially those whose disease did not respond to PD-1/PD-L1 therapy. These studies are mainly looking at whether the treatment combination can help shrink tumors and improve outcomes, while also tracking safety and overall survival.
Key points
- Clinical trial data for Ltx-315 focus on advanced melanoma, especially in patients whose disease did not respond to PD-1/PD-L1 inhibitor therapy. The main study listed is a Phase 2 trial that tested Ltx-315 with pembrolizumab. Researchers measured overall response rate, clinical benefit rate, and overall survival. The trial enrolled 37 patients and is now completed. This means the study has already finished and the results were reviewed.
Trial overview
The main clinical trial in the data is NCT04796194, a Phase 2 study of Ltx-315 in combination with pembrolizumab for people with advanced melanoma. The study was designed to evaluate preliminary anti-tumor activity in patients whose cancer had failed or was refractory to anti-PD-1/anti-PD-L1 therapy.
Who was studied
This trial focused on people with advanced melanoma, which is a serious skin cancer that has spread or is harder to treat. The target population included patients who had already tried PD-1/PD-L1 inhibitor therapy without enough benefit, meaning their cancer did not respond well to those treatments.
Treatment being tested
The study tested Ltx-315 together with pembrolizumab, which is also known by the brand name Keytruda in the trial data. The trial also listed supportive medicines: cimetidine, chlorphenamine, and montelukast. Ltx-315 was given by intratumoral use, meaning it was placed directly into the tumor.
Study phase and design
This was an interventional study, which means the research team gave the treatment and watched what happened. It was a Phase 2 trial, a stage that usually looks more closely at whether a treatment may work in a specific disease group while continuing to observe safety and tolerability.
What the researchers measured
The main outcome was overall response rate (ORR), defined as the share of patients who had a partial response or complete response by local investigator review using RECIST version 1.1. A partial response means the tumors got smaller, and a complete response means no visible cancer was found by the study rules.
The study also measured clinical benefit rate (CBR), which counted patients with stable disease, partial response, or complete response using iRECIST. Stable disease means the cancer did not clearly get better or worse for a time. Another key endpoint was overall survival (OS), measured from the start of treatment until death.
Study status and size
The trial enrolled 37 patients and is listed as completed. Because the study is finished, the data describe a closed research project rather than an ongoing trial looking for new participants.