Trial results for the Phase 1/2 study (NCT03035331) investigating pembrolizumab in combination with dendritic cell therapy and cryosurgery for Non-Hodgkin Lymphoma were posted on ClinicalTrials.gov on 2025-05-16. The study reported 0 dose-limiting toxicities in the Phase 1 dose level 1.
Background
Pembrolizumab (Keytruda) is an immunotherapy often used in various cancers. This trial investigated its use in combination with dendritic cell therapy and cryosurgery for patients with Non-Hodgkin Lymphoma. Dendritic cell therapy, made from a person's tumor cells and white blood cells, aims to help the body build an effective immune response to kill tumor cells. Cryosurgery kills cancer cells by freezing them.
Trial design
The study (NCT03035331) was a Phase 1/2 trial, titled 'Dendritic Cell Therapy, Cryosurgery, and Pembrolizumab in Treating Patients With Non-Hodgkin Lymphoma'. It enrolled 11 participants with conditions including Aggressive Non-Hodgkin Lymphoma, Indolent Non-Hodgkin Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Follicular Lymphoma, and Recurrent Mantle Cell Lymphoma. The interventions included dendritic cell therapy, pembrolizumab, and pneumococcal 13-valent conjugate vaccine.
Key results
The trial results provided several key measurements for the combination therapy:
- For "Number of Patients That Experienced a Dose Limiting Toxicity (DLT)" in Phase 1 Dose Level 1, the count was 0 Participants.
- The "Percentage of Complete Responses of Combination Therapy With Pembrolizumab, Cryoablation, and Intra-tumor Injection of Autologous Dendritic Cells (DC) at Maximum Tolerated Dose (MTD) Dose" was 0 percentage of patients for both Phase 1 Dose Level 1 and Phase 2 Dose Level 1.
- Median "Progression Free Survival" was 5 Months (95% Confidence Interval) for Phase 1 Dose Level 1 and 3.6 Months (95% Confidence Interval) for Phase 2 Dose Level 1.
- Median "Treatment Free Survival" was 15.8 months (95% Confidence Interval) for Phase 1 Dose Level 1 and 18.1 months (95% Confidence Interval) for Phase 2 Dose Level 1.
- Median "Duration of Response" for All Patients was 6 months (95% Confidence Interval).
- The "Disease Free Survival Rate" was 0 percentage of patients for both Phase 1 Dose Level 1 and Phase 2 Dose Level 1.
- Median "Overall Survival" was reported as NA months (95% Confidence Interval) for both Phase 1 Dose Level 1 and Phase 2 Dose Level 1.
What this means
The results from this Phase 1/2 trial indicate that the combination of pembrolizumab, dendritic cell therapy, and cryosurgery demonstrated a favorable safety profile in terms of dose-limiting toxicities, with 0 Participants experiencing a DLT in Phase 1 Dose Level 1. However, the efficacy outcomes, including 0 percentage of patients achieving a complete response and a 0 percentage of patients disease-free survival rate, suggest that the combination therapy did not achieve significant tumor responses in this small cohort of Non-Hodgkin Lymphoma patients. The median progression-free survival and treatment-free survival provide some insights into disease control and duration of treatment benefit, but the overall lack of complete responses points to challenges for this specific combination in this patient population.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03035331, titled 'Dendritic Cell Therapy, Cryosurgery, and Pembrolizumab in Treating Patients With Non-Hodgkin Lymphoma,' were posted on 2025-05-16 on clinicaltrials.gov.