ClinicalTrials.gov posted results on 10 September 2026 for a completed Phase 2 study of pembrolizumab combined with LTX-315 in advanced melanoma. The open-label, single-arm trial enrolled 23 participants; posted measurements included response counts, rates of 13.6% and 40.9%, and treatment-emergent adverse-event counts related to LTX-315.
Background
The ATLAS-IT-05 study evaluated intratumoral LTX-315 in combination with pembrolizumab for people with advanced melanoma whose tumors were accessible for injection. Eligible tumors could be cutaneous, subcutaneous, in lymph nodes, or intramuscular. Participants had either exhausted treatment options or were not eligible for, suitable for, or willing to undergo those treatments.
Trial design
This completed Phase 2 trial, identified as NCT04796194, was open-label and single-arm. It enrolled 23 participants with advanced melanoma and listed LTX-315 in combination with pembrolizumab as the intervention. The record did not provide primary-outcome entries.
Key results
For objective response rate, the record listed participant counts of 0 participants, 3 participants, 6 participants, 12 participants, and 1 participant for the LTX-315 and pembrolizumab group. It also reported two rate analyses of 13.6% (90% CI, 3.822% to 31.591%) and 40.9% (90% CI, 23.272% to 60.484%). The supplied analysis entries did not specify the outcome names or methods, so the record does not establish which rate corresponds to which response measure.
For clinical benefit rate, the listed participant counts were 0 participants, 3 participants, and 6 participants. Overall survival was reported as a median of NA weeks, with no interquartile-range value supplied.
For treatment-emergent adverse events related to LTX-315, the record listed counts of 20 participants, 10 participants, and 1 participant. The supplied data did not identify the categories represented by these counts or provide a comparative adverse-event summary.
What this means
The posted results provide response-related counts and two rate analyses for the LTX-315–pembrolizumab combination in a small, single-arm advanced-melanoma study. Because there was no comparator arm, no listed primary-outcome entry, and no specified mapping for the rate analyses, the data do not establish comparative efficacy. The record also does not provide enough detail to characterize safety beyond the listed adverse-event counts.
Source
Source: ClinicalTrials.gov, registry results for the completed ATLAS-IT-05 Phase 2 study of intratumoral LTX-315 in combination with pembrolizumab in advanced melanoma, posted 10 September 2026. Available at clinicaltrials.gov/study/NCT04796194.