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Ltx-315

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.

Table of Contents

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.[1] 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.[1]

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.[1] 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.[1]

Treatment being tested

The study tested Ltx-315 together with pembrolizumab, which is also known by the brand name Keytruda in the trial data.[1] The trial also listed supportive medicines: cimetidine, chlorphenamine, and montelukast.[1] Ltx-315 was given by intratumoral use, meaning it was placed directly into the tumor.[1]

Study phase and design

This was an interventional study, which means the research team gave the treatment and watched what happened.[1] 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.[1]

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.[1] A partial response means the tumors got smaller, and a complete response means no visible cancer was found by the study rules.[1]

The study also measured clinical benefit rate (CBR), which counted patients with stable disease, partial response, or complete response using iRECIST.[1] Stable disease means the cancer did not clearly get better or worse for a time.[1] Another key endpoint was overall survival (OS), measured from the start of treatment until death.[1]

Study status and size

The trial enrolled 37 patients and is listed as completed.[1] Because the study is finished, the data describe a closed research project rather than an ongoing trial looking for new participants.[1]

Trial ID Phase Condition studied Status Enrollment
NCT04796194 Phase 2 Advanced melanoma Completed 37

FAQ

  • What is being studied in the Ltx-315 clinical trials? The trial is studying Ltx-315 given with pembrolizumab in people with advanced melanoma. It is looking at whether the combination has anti-tumor activity, meaning whether it can help control or reduce the cancer.
  • Who can take part in these trials? The study focused on patients with advanced melanoma who had failed or were refractory to PD-1/PD-L1 inhibitor therapy. In simple terms, these are people whose cancer did not improve with certain earlier immune treatments.
  • What phase is the Ltx-315 trial? The trial is a Phase 2 study. Phase 2 trials usually look more closely at whether a treatment works in a specific group of patients, while also continuing to monitor safety.
  • What results were the researchers measuring? The main results were overall response rate, clinical benefit rate, and overall survival. These measure how many patients had tumor shrinkage or disease control, and how long patients lived after starting treatment.
  • Is the Ltx-315 study still recruiting patients? No. The trial listed here is completed. That means the study has already finished collecting and reviewing its results.

Ongoing Clinical Trials on Ltx-315

  • Study of LTX-315 and Pembrolizumab for Patients with Advanced Melanoma Resistant to PD-1/PD-L1 Therapy

    Not recruiting

    1 1 1
    Investigated drugs:
    France Norway Spain

Glossary

  • Advanced melanoma: A serious form of skin cancer that has spread further in the body or cannot be removed easily with surgery.
  • PD-1/PD-L1 inhibitor therapy: A type of cancer treatment that helps the immune system attack cancer cells. The trial included people whose cancer did not respond to this treatment.
  • Refractory: Not responding to treatment, even after it has been given.
  • Phase 2: A study stage that checks whether a treatment may work in a certain disease and continues to watch for safety.
  • Interventional study: A study where researchers give a treatment and then measure what happens.
  • Pembrolizumab: A cancer medicine given in the study together with Ltx-315.
  • Intratumoral use: Given directly into the tumor.
  • Overall response rate (ORR): The percentage of patients whose tumors got smaller or disappeared according to study rules.
  • Clinical benefit rate (CBR): The percentage of patients who had no worsening of disease or had some level of tumor response.
  • Overall survival (OS): The length of time from the start of treatment until death from any cause.
  • RECIST 1.1: A standard way to measure whether tumors shrink, stay the same, or grow.
  • iRECIST: A response measurement system used in immunotherapy studies to judge whether cancer is controlled.

References