In short
Clinical trials are investigating AUTOLOGOUS DENDRITIC CELLS LOADED WITH ALLOGENIC ALLOGENEIC LYSATE OF MESOTHELIOMA CELL LINES in people with peritoneal mesothelioma and borderline resectable pancreatic cancer. These studies aim to evaluate outcomes such as progression-free survival and overall survival, often alongside surgery or chemotherapy. They are in Phase 2 and Phase 4 and are enrolling adults with specific cancers.
Key points
- Clinical trials of AUTOLOGOUS DENDRITIC CELLS LOADED WITH ALLOGENIC ALLOGENEIC LYSATE OF MESOTHELIOMA CELL LINES are being done in two cancer settings: peritoneal mesothelioma and ABC borderline resectable pancreatic cancer. One study is Phase 2 and looks at the treatment with nivolumab, surgery, and HIPEC in 18 patients. The other is a Phase 4 study in 143 patients with pancreatic cancer after FOLFIRINOX chemotherapy. The main outcomes are progression-free survival and overall survival. Both trials are authorised and focused on whether this treatment can improve cancer control in these specific patient groups.
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. One trial studies it in peritoneal mesothelioma, and the other studies it in ABC borderline resectable pancreatic cancer.
Both studies are looking at whether the treatment can improve important cancer outcomes such as progression-free survival or overall survival. The trials are not simple drug-only studies, because they test the treatment together with other cancer treatments already planned for these patients.
Conditions being studied
The first study includes people with peritoneal mesothelioma, a cancer that affects the lining inside the abdomen. This trial is designed around treatment given before and after surgery, with the aim of assessing efficacy around CRS-HIPEC.
The second study includes people with ABC borderline resectable pancreatic cancer. “Borderline resectable” means the cancer may still be removable with surgery, but it is close to important structures, so treatment planning is more complex.
Who can participate
Based on the trial data, the target populations are adults with the specific cancer types listed in each study. The mesothelioma study is for patients with peritoneal mesothelioma, while the pancreatic study is for patients with ABC borderline resectable pancreatic cancer.
The available data do not list extra details such as age limits, lab test requirements, or other entry rules. They do show that both studies are interventional, meaning participants receive planned treatment as part of the research.
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. This study includes nivolumab, AUTOLOGOUS DENDRITIC CELLS LOADED WITH ALLOGENIC ALLOGENEIC LYSATE OF MESOTHELIOMA CELL LINES, cytoreductive surgery, and hyperthermic intraperitoneal chemotherapy (HIPEC).
The brief summary says the goal is to assess the efficacy of checkpoint inhibition with nivolumab and dendritic cell therapy around CRS-HIPEC. 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.
In the pancreatic cancer study, the treatment is given after FOLFIRINOX chemotherapy. 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.
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. This outcome is used to judge whether the treatment plan can help delay disease progression in this setting.
The pancreatic cancer study includes two key outcomes in its primary outcome description. 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. The Phase III endpoint is overall survival, which is the time from inclusion until death from any cause.
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.
Trial status and enrollment
Both trials are listed as Authorised. The mesothelioma study plans to enroll 18 participants, while the pancreatic cancer study plans to enroll 143 participants.
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. Together, these trials show how this treatment is being tested in different cancer settings and at different stages of clinical research.