This trial is evaluating whether cemiplimab will improve 2 primary outcomes and 3 secondary outcomes in patients with Glioma. Measurement will happen over the course of 6 months.
This trial requires 24 total participants across 2 different treatment groups
This trial involves 2 different treatments. Cemiplimab is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.
Gliomas are the most common form of [brain tumor](https://www.withpower.com/clinical-tri[als](https://www.withpower.com/clinical-trials/als)/brain-tumor) in adults. The peak incidence in adults is in the age 50-69 years, suggesting that the brain is more vulnerable to insult in the fourth decade or later in life. The average age of onset is 30.5 years, and most are benign. Treatment depends on the location and grade of the tumor. The survival rate for patients with low-grade tumors (II and III) is greater than 90%, but declines for patients with high-grade tumors (IV). The 5-year survival rate is 15% for patients classified as having glioma IV. The American Cancer Society also lists several rare cancers that can occur along with glioma.
Recent findings indicates that there is an increased risk of gliomas in smokers compared with nonsmokers, which is a plausible explanation for the observation that up to one half of all cases of glioma occur in smokers. The increased risk may be caused by one or more carcinogens in cigarette smoke.
Glioma may present itself in ways like headache, vomiting, drowsiness, loss of coordination, numbness, pain and dizziness. If the signs of glioma are present early, medical professionals should be alerted or the patient should be referred to a consultant and MRI should be started soon.
Approximately 9,900 new cases of glioma were detected in the U.S. per year, an annual incidence of 4.2 cases per 10,000. The highest incidence of glioma occurred in persons under the age of 20, and persons over 60 at risk of this cancer were disproportionately represented among all races and ethnic groups.
Patients with glioma are likely to be treated with radiotherapy, and then chemotherapy. Radiotherapy may be used alone or along with chemotherapy. Chemotherapy may be used in conjunction with radiotherapy and can be used as monotherapy, but is most commonly combined with radiation. There are currently no drugs or combinations of drugs which cure glioblastoma, but treatment can prolong life and delay progression. There is no evidence that using one chemotherapy agent alters the response of the patient to the other. In terms of survival in the treatment of gliomas, there are significant differences between adults and children, which must be considered when establishing treatment algorithms.
Glioma, though frequently fatal, is curable (50-60%). If the diagnosis and treatment are prompt, the chances are better. In some instances, treatment failures have been cured by a second operation. Patients with glioma should be informed of the curable fraction, and their children are at highest risk of dying sooner. This is an important issue that should be explored further. It also raises the possibility of cure or improvement as a treatment modality.
This retrospective study provides a glimpse at the spectrum, including the elderly patients and the female demographics, of patients treated with cemiplimab. These preliminary data suggest that in the cemiplimab-treated group, the median duration of PFS is 20.0 months. In the cemiplimab-treated group, overall survival was 4.2 months.
Because of our data analysis it is difficult to determine a single factor as the primary cause for glioma. For instance, our data suggests that increased frequency of cigarette cigarettes smoking (smoking is strongly associated with gliomas, P<0.001), high cumulative exposure of ionizing radiation (lack of exposure to any irradiation, no link, P=0.10), and family history of glioma (P = 0.015). These data are a reflection of our country’s demographic characteristics, but they support epidemiological studies performed in similar regions, where smoking, radiation, and family history are more common. We could conclude that any cancer incidence increases or decreases depending on environmental variations.
Cemiplimab as a single therapy does not appear to be likely to significantly impact survival in the treatment of refractory GBM. The role of cemiplimab as a single agent is limited by its toxicity and in vivo efficacy is yet to be established. ClinicalTrials.gov number: NCT01824085. summary: This article describes the results of combining cemiplimab (NVP-BEZ235) with other treatments for treatment of patients with recurrent or refractory diffuse glioma.
We did not find an increased occurrence in families with a family history of tumors in other systems, other than pancreatic and breast cancer, but the data in this paper is insufficient to define a clear cause or effect relationship and therefore is an open question. Further observations and studies are warranted to assess the hereditary nature of glioma susceptibility.
This work is the first to show the pharmacodynamic effect of CTP in human tumors. Specifically we demonstrate the effect of CTP on tumor-infiltrating lymphocytes, the cytokine secretion profile and the induction of apoptosis in tumors, which suggests that CTP may target T cells with special relevance for malignant gliomas, as these tumors are infiltrated by T cells in various ways.
Cemiplimab as monotherapy may contribute to a significant number of tumor responses in pretreated patients with metastatic melanoma or advanced non-small-cell lung cancer in a study that included patients with mutant BRAF or IDH mutations.