Pembrolizumab for Oral Squamous Cell Carcinoma
This study is evaluating whether pembrolizumab (a therapy that activates the immune system to fight cancer) can be safely added to standard of care treatment for head and neck cancer.
See full descriptionAbout the trial for Oral Squamous Cell Carcinoma
Treatment Groups
This trial involves 2 different treatments. 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 2 and have already been tested with other people.
About The Treatment
Eligibility
This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Pembrolizumab will improve 3 primary outcomes and 1 secondary outcome in patients with Oral Squamous Cell Carcinoma. Measurement will happen over the course of 1 week.
Patient Q & A Section
How does pembrolizumab work?
Considering that the majority of ATC-treated patients in this study show good clinical response and disease stabilization in almost one third of patients, we show that pembrolizumab treatment provides some clinical benefits for ATC patients.
What are common treatments for oral squamous cell carcinoma?
Surgical resection. The standard treatment for the majority of people with oral cancer is surgical resection; however, this option is associated with numerous complications, including a high complication rate, high postoperative recurrence and decreased quality-of-life, and should be weighed carefully when considering treatment options. Clinical oncologists should be familiar with the treatment options for oral cancer in order to provide patients with the best possible management. In addition to surgical resection, definitive therapy and adjuvant therapies including chemotherapy, radiation therapy, and targeted therapy have all demonstrated efficacy and should be offered to patients with oral cancer.
What is oral squamous cell carcinoma?
Oral cancer is a cancer that usually forms on the gingiva, the mouth's lining, and can form as early as birth. The most common early form of oral cancer, which rarely spreads, is called oral squamous cell carcinoma. Oral melanomas, although rare, are the most deadly type of oral cancer. Oral cancer accounts for 12% of cancers in the UK, with 923 new cases of oral cancer and 744 deaths from oral cancer in 2016 according to the Cancer Research UK. The lifetime risk of oral cancer is 1:35 for males and 1:40 for females, compared with 1:50 in general.
How many people get oral squamous cell carcinoma a year in the United States?
The incidence of oral squamous cell carcinoma in the United States has been steadily declining and, based on current surveillance records from 1979 to 2008, the rate has stabilized around 6.4 cases per 100,000 population. The prevalence of oral squamous cell carcinoma at an earlier age and in women has contributed to this decline. This decline has not been observed in other parts of the world where the disease is more frequent and at an older age.
Can oral squamous cell carcinoma be cured?
This cohort of patients with operable stage IV oral cancer had a higher rate of long-term survival relative to other studies in advanced patients in the U.S., with the most significant difference observed at >5 yr.
What are the signs of oral squamous cell carcinoma?
Oral carcinoma is not a systemic disease, like most cancers. Instead, it is a disease of specific tissues, with distinct signs. For oral tumor, we may not only focus on the signs and symptoms after the appearance, but also signs and symptoms before it appears.
What causes oral squamous cell carcinoma?
Approximately 50% of cases are associated with human papilloma virus (HPV) 16, which is present in most populations and is most frequently seen on the tongue. The remaining cases are probably related to chronic irritation or injury to the tongue. The use of tobacco and alcohol are more frequent in elderly people with OSCC. Oral cavity cancer is the most common cancer in the mouth, but it is relatively rare in the United Kingdom. A national registry is currently collecting data that could help to explain the increased prevalence in Western societies.
What is the average age someone gets oral squamous cell carcinoma?
The mean age of diagnosis of OSCC in the United States has dropped by 10 yr per decade since 1997, and its clinical spectrum have become more aggressive. Given the lack of knowledge of an age when OSCC first presents, surveillance and early detection of OSCC in younger and older patients are of critical importance.
What are the chances of developing oral squamous cell carcinoma?
It takes 4 years on average. There is an increasing trend associated with increasing age but there's no relationship with occupation or education. Oral SCC is very likely to be the most common [head and neck cancer](https://www.withpower.com/clinical-trials/head-and-neck-cancer) especially in males with the exception of laryngeal cancer whose incidence is lower in the elderly. The disease is thought as a consequence of prolonged use of oral cavity and teeth. These associations are mainly observed in patients of either African or mixed descent.
Is pembrolizumab safe for people?
Pembrolizumab was found to be safe in this patient population of SCCM patients with PDL. Pembrolizumab was well tolerated. Pembrolizumab was associated with a shorter OS than Cetuximab in this patient population.
Is pembrolizumab typically used in combination with any other treatments?
Pembrolizumab is used alone or in combination with other agents with a frequency higher than expected in this pooled analysis. Combination in use of pembrolizumab appears to be associated with increased overall survival in advanced solid tumors.
What are the common side effects of pembrolizumab?
Common adverse events in people administered pembrolizumab to treat the disease: <10% of patients experience diarrhea, <5% of patients experience pruritus,<5% of patients experience constipation, <5% experience nausea, vomiting, <5% of patients experience fatigue, <10% of patients experience pain, and <5% of patients experience dyspnoea.<5% of patients experience serious adverse events and these include <4% who discontinue the treatment due to adverse effects. Most adverse events are thought to be associated with TNF-alpha blockade like these. The majority of patients do not experience any safety concerns.