Table of contents
- Overview of the trials
- Conditions being studied
- Who can participate
- Trial designs and treatment plans
- Main outcomes being measured
- Trial status and enrollment
Overview of the trials
Two authorised interventional trials are investigating AUTOLOGOUS DENDRITIC CELLS LOADED WITH ALLOGENIC ALLOGENEIC LYSATE OF MESOTHELIOMA CELL LINES in cancer care.[1][2] One trial studies it in peritoneal mesothelioma, and the other studies it in ABC borderline resectable pancreatic cancer.[1][2]
Both studies are looking at whether the treatment can improve important cancer outcomes such as progression-free survival or overall survival.[1][2] The trials are not simple drug-only studies, because they test the treatment together with other cancer treatments already planned for these patients.[1][2]
Conditions being studied
The first study includes people with peritoneal mesothelioma, a cancer that affects the lining inside the abdomen.[1] This trial is designed around treatment given before and after surgery, with the aim of assessing efficacy around CRS-HIPEC.[1]
The second study includes people with ABC borderline resectable pancreatic cancer.[2] “Borderline resectable” means the cancer may still be removable with surgery, but it is close to important structures, so treatment planning is more complex.[2]
Who can participate
Based on the trial data, the target populations are adults with the specific cancer types listed in each study.[1][2] The mesothelioma study is for patients with peritoneal mesothelioma, while the pancreatic study is for patients with ABC borderline resectable pancreatic cancer.[1][2]
The available data do not list extra details such as age limits, lab test requirements, or other entry rules.[1][2] They do show that both studies are interventional, meaning participants receive planned treatment as part of the research.[1][2]
Trial designs and treatment plans
In the peritoneal mesothelioma trial, the study tests a combination of neo-adjuvant and adjuvant treatment, which means treatment given before and after the main cancer procedure.[1] This study includes nivolumab, AUTOLOGOUS DENDRITIC CELLS LOADED WITH ALLOGENIC ALLOGENEIC LYSATE OF MESOTHELIOMA CELL LINES, cytoreductive surgery, and hyperthermic intraperitoneal chemotherapy (HIPEC).[1]
The brief summary says the goal is to assess the efficacy of checkpoint inhibition with nivolumab and dendritic cell therapy around CRS-HIPEC.[1] The primary outcome is progression-free survival in patients who received neo-adjuvant and adjuvant treatment with anti-PD-1 and vaccinations of DCT, with up to 5 administrations in total if there is no production shortage.[1]
In the pancreatic cancer study, the treatment is given after FOLFIRINOX chemotherapy.[2] The study is described as a dendritic cell immunotherapy trial after chemotherapy in patients with resectable pancreatic cancer, and the brief summary states that Phase II looks at progression-free survival while Phase III looks at overall survival.[2]
Main outcomes being measured
The main outcome in the mesothelioma trial is progression-free survival, which tracks how long patients remain without cancer growth or return after treatment starts.[1] This outcome is used to judge whether the treatment plan can help delay disease progression in this setting.[1]
The pancreatic cancer study includes two key outcomes in its primary outcome description.[2] The Phase II endpoint is progression-free survival, defined as the time from treatment start until recurrent disease, progressive disease by RECIST 1.1, or death from any cause, whichever happens first.[2] The Phase III endpoint is overall survival, which is the time from inclusion until death from any cause.[2]
These outcomes are important because they show not only whether the cancer is controlled for a period of time, but also whether the treatment may help people live longer.[1][2]
Trial status and enrollment
Both trials are listed as Authorised.[1][2] The mesothelioma study plans to enroll 18 participants, while the pancreatic cancer study plans to enroll 143 participants.[1][2]
The smaller enrollment in the mesothelioma study fits a focused Phase 2 design, while the larger pancreatic cancer study fits a broader later-stage research plan.[1][2] Together, these trials show how this treatment is being tested in different cancer settings and at different stages of clinical research.[1][2]
