This trial is evaluating whether pepinemab + pembrolizumab will improve 3 primary outcomes, 7 secondary outcomes, and 3 other outcomes in patients with Oral Squamous Cell Carcinoma. Measurement will happen over the course of 2 Years.
This trial requires 65 total participants across 2 different treatment groups
This trial involves 2 different treatments. Pepinemab + Pembrolizumab 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 1 & 2 and have already been tested with other people.
The incidence of OSCC has increased in recent decades in many countries of the world. This has been attributed to factors such as increased risk for xerostomia or a younger age at time of diagnosis. The role of hepatitis B and smoking is still unclear.
Oral squamous cell carcinoma is a malignancy that originates in the oral mucosa and produces ulcers, swelling, redness, pain, and tenderness in the mouth of epithelial tissue. The disease is diagnosed after a biopsy is done to exclude the presence of a mycotic or other type of tumor. Oral cancers have a reputation as a cancer that involves only white people or persons of Jewish or Asian origins.\n
OST is a potentially curable disease with excellent prognosis. The signs of OST, which can mostly be detected in premalent stages of the disease, include painless and painful ulcers of the mouth and gingiva in relation to gingival hypertrophy, tooth mobility, black or green stains, ulcerated stomata (the mouth-breathing organs), swelling of the cheeks and cheeks, the cheeks as a part of the facial dimple (buccal mucosa), and a non-specific dental history including loss of teeth. These signs can reflect in a dental radiograph and can be observed in premalent stages of the disease.
Findings from a recent study suggest that the incidence of oral SCC could be higher than estimates from prior studies due to the longer period from lesion to diagnosis.
Although in this case, the tumours had metastasised to many parts of body, the treatment that consisted only of radiotherapy, plus one course of chemotherapy, resulted in a better local control of the tumour than other therapy options, when applied to localised condition.
Generally, the survival of patients with oral cancer is very good, regardless of the type, sites, or stages of oral cancers. To improve the survival outcome for this type of cancer, clinicians need to improve treatment modalities.
The 5-year survival rate for primary head and neck squamous cell carcinoma was 27% with a mean overall survival of 27 months. The survival rate for T1 was 60% with a mean overall survival of 16 months. Tumor diameter ≥ 3 cm was one of the most important prognostic factors for both T1 and T2 lesions, with a survival rate for T2 of 25% and T3 or worse of 30%. Overall survival for the entire cohort of 870 subjects was 26% with a mean overall survival of 21.5 months. The 5 year survival rate for patients with advanced T4 lesions was 7%, with a mean overall survival of 13.7 months.
The PEP-EZUMAB regimen is efficacious in patients who have previously received an chemotherapy regimen containing platinum plus taxanes in metastatic or locally advanced squamous cell carcinoma. It may be considered for treatment in patients with locally advanced or recurrent SSC.
Oral cancer remains a major health problem, yet little progress over the past 10 years. The reasons for this lack of progress are unknown, but research to understand the biologic cause of OSCC and to treat it with less toxicity and greater effectiveness remain important. Understanding the biologic mechanism by which cancers become malignant and developing effective treatments to disrupt their transformation are fundamental to progress in OSCC. Clinical trials provide a platform for conducting research to meet this goal. If results in these trials show that new treatment strategies are effective, an important next step would be to conduct Phase III clinical trials for OSCC. Recent advances are also guiding treatment strategies for other forms of OSCC that are currently more common in Europe and the East.
The probability of receiving a trial might be higher for all patients, but most should look at their physicians, family member, or family practitioner first before enrolling. There is a much better idea of benefit to patients who have either systemic, local, and/or adjuvant treatment.
Of all the oral cancers studied in one large-scale longitudinal study, OSCC comprised 13% of the cases. Risk estimates of developing OSCC varied with age and sex, but it was always high. It was more common than expected in patients with a family history of buccal carcinoma, and it was less common than expected in patients with a family history of OSCC. This information may be useful for patient counseling and in risk stratification in oral cancer screening studies.
Although many of the risk factors for oral cancer are known, only half of the cancers have a hereditary component and only a minority are due to germ-line mutations in one of the known TSGs.