This trial is evaluating whether Cemiplimab-Rwlc will improve 1 primary outcome and 3 secondary outcomes in patients with Oral Squamous Cell Carcinoma. Measurement will happen over the course of Up to 9 months.
This trial requires 44 total participants across 2 different treatment groups
This trial involves 2 different treatments. Cemiplimab-Rwlc is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
Oral squamous cell carcinoma is usually treated surgically by external beam radiation therapy or by intravascular brachytherapy. Chemotherapy is often used and often effective, but is more useful in early stages. In recent years, adjuvant chemotherapy has proven to be useful in advanced stages.
Around 5,000 people develop a new oral carcinoma a year in the United States. Most of these cases are attributable to tobacco use. Most of the time, this is in addition to a previous malignancy, which may have been caused by the same exposures or by carcinogens already in the mouth.
The signs and symptoms of oral SSCC are nonspecific and difficult to detect until advanced disease. The most informative signs are those with a temporal or regional habit. The signs and symptoms in a patient with a diagnosis of SSCC should be asked about.
OSCC is not a cancer common in the UK; its incidence rate is low. Most cases reported are in the 25-50 age group. For this reason, there is a real risk of unnecessary treatment that will not help the patient's long-term well-being. Oral surgery requires a high degree of expertise; there is a case for a high specialist referral centre with multidisciplinary team-based management at the forefront of the team. A good collaboration with medical oncologists is needed.
Data from a recent study indicated the importance of early detection and treatment when OSCC was diagnosed. Nevertheless, treatment can not totally eliminate or cure OSCC. Therefore, OSCC patients and their families should be advised to know the information before treatment is chosen.
Most oral cancers occur from environmental factors. High-risk groups that have other disease predispositions, such as smoking, drinking heavily, or having a family history of cancer, also have an increased risk. High-risk groups that do not have any predisposition to cancer have a low cancer risk. Tobacco is the prime cause of oral cancer in this group.
Results from a recent clinical trial suggest that oral cancer patients with high-grade tumors, especially those with T3 or T4 tumors, have a significantly higher risk of DM and renal (kidney) cancer. However, OSCC is generally a disease which appears after other chronic diseases are diagnosed. This makes it difficult to treat even patients with localized oral cancer. It is generally impossible to diagnose before other chronic diseases are diagnosed. This means that when oral cancer is diagnosed, oral cancer is frequently already disseminated. When the oral cancer is localized, treatment, as for other cancers, should be carried out.
The Phase I experience demonstrated that cemiplimab at a dose of 5 mg/m(2) weekly is safe and well-tolerated in people with advanced solid tumors or, more particularly, metastatic NSCLC.
None. Most studies are low-quality and need further assessment. It should be considered to use randomised controlled trials for oral cancer treatment. More studies about oral oncology are needed to identify treatment patterns and trends in the last three years.
Cemiplimab-rwlc treatment significantly increased QoL in the majority of patients with oral SCC. Further investigation is warranted to determine the exact role of this antibody and its possible utility in the treatment of oral SCC.
The current literature has continued to reveal the need for targeted therapies as well as the use of combinations of agents against oral squamous cell carcinoma. In light of advancements in molecular and cellular biology, targeted therapies against oral cancer will provide patients with a more individualized treatment strategy.
For metastatic disease with progressive disease progression, pembrolizumab-rwlc should be considered for patients with BRAF V600 mutation or those who are treated with BRAF V360 mutation. For patients with BRAF V180 mutation or those who are treated with BRAF V160 mutation, cemiplimab-rwlc may also be considered. Patients without a BRAF mutation should be treated with the standard of care, cemiplimab treatment.