This trial is evaluating whether zenocutuzumab (MCLA-128) will improve 4 primary outcomes and 13 secondary outcomes in patients with Cancer of Pancreas. Measurement will happen over the course of 36 months.
This trial requires 250 total participants across 3 different treatment groups
This trial involves 3 different treatments. Zenocutuzumab (MCLA-128) is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.
Cancer of pancreas is mainly caused by pancreatic ductal adenocarcinoma (85%), followed by neuroendocrine tumors (10%), and ampullary cancers (4%). There is a low incidence in colorectal cancers, and a high incidence in gastric cancers. Most of pancreatic cancer patients are diagnosed before the age of 50, and most of the population has an advanced cancer at diagnosis. There are only limited chances of cure, especially for node-positive disease. However, pancreatectomy has improved the prognosis. The overall 5-year survival rate is still less than 5% in most of countries, with a 5-year survival rate as low as 1% for localized disease and 1.
Rates of pancreas cancer are increasing in whites because of changing patterns of morbidity. Because the rate of pancreas cancer increases with age, it is imperative to implement screening and diagnostic testing for pancreatic cancer.
Signs of pancreatic carcinoma typically involve a painless lump that is hard or rubbery, as well as numbness around the lump, and jaundice, which is generally in the setting of a mass. The tumor may be present in the liver as it is common for pancreatic cancer to spread through this organ.\n
The most common treatments for cancer of the pancreas include chemotherapy (cytotoxic chemotherapy), radiation therapy, and surgical resection. There is also strong evidence to support palliative care and supportive care as useful components of comprehensive care of cancer patients.
Genetic factors may not always be the only determinants of the onset of CP, and it may be important to consider the environmental determinants of cancer in a population as a whole.
Overall 5-year survival is only 10 percent in patients with localized disease, however local disease recurrence rate is very high. The recurrence rate is similar in patients with locally advanced disease, but the overall survival rate is significantly poorer than in locally advanced disease.
The study showed that only 20 % of patients did not survive more than a couple of years following diagnosis, while 90 % of those patients have survived till today. After more than 7 years, the survivors are still having the same signs and symptoms as those who had those symptoms within the first year post-diagnosis. Overall, the disease affects the digestive system, where more than half of surviving patients complain of chronic pain, which is an important factor for quality of life.
With an exception of peripheral neuropathy, all of our patients with recurrent glioma showed improvement in their disease at month 12 from the commencement of zenocutuzumab (mcla-128). For these patients, zenocutuzumab resulted in a very small probability of disease progression for a prolonged period. However, some patients showed no disease progression before the commencement of zenocutuzumab (mcla-128); it is important to consider this when evaluating patients who respond or do not respond to treatment with zenocutuzumab (mcla-128), particularly in patients with metastatic disease.
The likelihood of developing pancreatic cancer is 2.3 times higher among those with diabetes or hypertension than normal BMI group. The lifetime risk of developing pancreatic is 5.0% in elderly normo-hypertensive diabetic subjects.
On the basis of the present observations, no dose escalation of zenocutuzumab is feasible, given the low toxicity profile; and, overall, the safety and antitumour activity of the zenocutuzumab regimen as determined in this study were similar to that of the randomized controlled trial study (see ZELIG Study). Further evaluations of this approach are warranted in the context of phase II and III clinical trials in patients with SMA.
Recent findings demonstrates that cancer of pancreatic is not autosomal dominant disease and is unlikely to run in families. The lack of association seen in this study argues against the possibility of an environmental or a genetic component. However, since cancer of pancreas has an extremely high mortality, some environmental and genetic factors cannot completely be ruled out.
We believe that our patients would be well served if zenocutuzumab is made part of their treatment, either in combination with gemcitabine or bacillus Calmette-Guérin.