Trial results for the study NCT03325101, investigating pembrolizumab in combination with therapeutic autologous dendritic cells for metastatic or unresectable melanoma, were posted on ClinicalTrials.gov on 2025-06-12. The study reported 0 dose-limiting toxicities (DLTs) in participants during the first three cycles of treatment across both Phase 1 schedules.
Background
The trial investigated the combination of pembrolizumab with therapeutic autologous dendritic cells for patients with Stage III or IV cutaneous melanoma that is metastatic or unresectable. Pembrolizumab is a monoclonal antibody. The study aimed to evaluate how well this combination works in treating patients with melanoma, with dendritic cell therapy after cryosurgery.
Trial design
The study, identified as NCT03325101, was a Phase 1/Phase 2 trial that enrolled 7 participants. It investigated the combination of pembrolizumab and therapeutic autologous dendritic cells in patients with Stage III Cutaneous Melanoma AJCC v7, Stage IIIA Cutaneous Melanoma AJCC v7, Stage IIIB Cutaneous Melanoma AJCC v7, Stage IIIC Cutaneous Melanoma AJCC v7, and Stage IV Cutaneous Melanoma AJCC v6 and v7 that was metastatic or unresectable.
Key results
The trial reported on the safety profile of the combination therapy. For the outcome "Number of Participants Who Developed a DLT During the First 3 Cycles of Treatment":
- In the Phase I Schedule 1 group, 0 participants developed a dose-limiting toxicity.
- In the Phase I Schedule 2 group, 0 participants developed a dose-limiting toxicity.
Regarding the "Incidence of Adverse Events" in the Phase I Schedule 1 group, the following participant counts were reported for various adverse events: 1, 1, 1, 2, 1, 2, 2, and 1 participants.
What this means
The absence of dose-limiting toxicities in both Phase 1 schedules suggests a favorable safety profile for the combination of pembrolizumab with therapeutic autologous dendritic cells at the doses evaluated in this early-phase study. This finding is important for the potential progression of this combination therapy to further clinical development for patients with metastatic or unresectable melanoma. However, given the small enrollment of 7 participants, these safety observations are preliminary and require validation in larger studies.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03325101, titled "Dendritic Cell Therapy With Pembrolizumab for Metastatic or Unresectable Melanoma," were posted on 2025-06-12 on clinicaltrials.gov.