This trial is evaluating whether Eftilagimod alpha will improve 1 primary outcome, 10 secondary outcomes, and 3 other outcomes in patients with Oral Squamous Cell Carcinoma. Measurement will happen over the course of At Screening: three weeks prior to cycle 1 day 1.
This trial requires 154 total participants across 3 different treatment groups
This trial involves 3 different treatments. Eftilagimod Alpha 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 2 and have already been tested with other people.
When given in a subcutaneous formulation, eftilagimod alpha is safe and well-tolerated when given across a broad spectrum of conditions. Given the favorable PK/PD profile, the risk of a SAE in people is low.
Although all patients with oral squamous cell carcinoma need to be evaluated and treated on a case-by-case basis, there may be opportunities for routine assessment, monitoring and treatment with eftilagimod alpha in cases of oral squamous cell carcinoma.
Oral and oropharyngeal squamous cell carcinomas are often accompanied by erythema nodosum-like conditions, and this is thought to be associated with increased recurrence rates and a higher incidence of lymph node invasion.
The vast majority of patients undergoing treatment for advanced OSCC have complete (95%) responses to the treatment regimen. The authors conclude that OSCC can be cured if treatment is provided early and intensively.
There is only limited evidence available regarding the use of these various modes of treatment for OSCC and future clinical research is needed to identify the best treatment for this prevalent disease.
The disease is one that causes abnormal bleeding in the mouth of an individual or a group of people and is often asymptomatic. The tumour in the mouth was first described in the 17th Century and has a poorer prognosis than other forms of oral cancer. However, the tumour is not the only form of cancer that occurs in this region of the body and is often metastasized and often lethal from disease present in the skin and lungs.
About 30,000 new cases are diagnosed annually in the United States. The incidence of oral cancer is higher in blacks than in whites. The lifetime risk of getting oral cancer is similar for whites and blacks.
This is the largest pooled analysis to date comparing oral SCC and oral AKA OEDC with respect to risk factors, histologic subtype, and clinical behaviors. Significant factors include smoking and HPV, but age and gender are the strongest risk factors. The combination of HPV and smoking increase the risk of developing high-grade OEDC.
Oral SCC remains a serious and growing health and economic burden in the United States. It is necessary for oral surgeons to keep up with the latest research information on oral SCC to remain current in their field. This article describes the latest research findings in oral cancers.
The most common safety finding was a change in the pattern of reported dermatologic conditions during the course of treatment. Other reported side effects included headache, fatigue, nausea, vomiting, diarrhea, and constipation. The incidence of adverse dermatologic effects was similar to previous studies of eftilagimod alpha treatment. There were no clinically meaningful changes in circulating immunoglobulin M, eosinophil cationic protein plasma levels, or C-reactive protein at the end of treatment. Results from a recent clinical trial suggest that eftilagimod alpha does not interact with circulating immunoglobulin M, eosinophil cationic protein, or C-reactive protein, or interfere with these circulating analytes.
There have been no newly discovered therapies for treating oral squamous cell carcinoma, and new drugs for treating the disease might be discovered only in the future. It is worthwhile to consider the possibility of treatments developed for other types of cancer in the future.
EFT is not more effective than a placebo in the treatment of ASCC. Additional studies are required to evaluate its effectiveness before it can be recommended as a viable alternative to platinum-based regimens.