CLINICAL TRIAL

Pembrolizumab for Oral Squamous Cell Carcinoma

High Risk
Waitlist Available · 18+ · All Sexes · Houston, TX

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 description

About the trial for Oral Squamous Cell Carcinoma

Eligible Conditions
Head and Neck Cancer · Carcinoma, Squamous Cell · Squamous Cell Carcinoma of Head and Neck

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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Cisplatin
DRUG
Surgery
PROCEDURE
Pembrolizumab
DRUG
Radiation Therapy
RADIATION
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
FDA approved
Surgery
1999
Completed Phase 3
~2060
Pembrolizumab
FDA approved
Radiation Therapy
2005
Completed Phase 3
~7080

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients eligible for resection with one or more of the following
Any T stage with ≥ N2 disease;
T4 disease, any N stage;
T3 Oral Cavity, any N stage; or Clinical evidence of extra-capsular extension on scans.
Must be willing to undergo definitive resection with neck dissection.
Performance status 0 or 1 on Eastern Cooperative Oncology Group Performance Scale.
Adequate labs
Appropriate staging imaging.
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 1 and 3 year
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 and 3 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 1 and 3 year.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

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.

Tumor immune response to pembrolizumab as measured by immunohistochemistry in tumor tissue before and after treatment
1 WEEK
1 WEEK
Number of participants with treatment related adverse effects as assessed using CTCAE v4.0 of pembrolizumab when combined with radiation alone and chemoradiation
30 DAYS FOLLOWING COMPLETION OF TREATMENT
Compare percentage of grade 3 and 4 adverse events with historical control percentages.
30 DAYS FOLLOWING COMPLETION OF TREATMENT
Disease free survival in resected intermediate risk patients treated with adjuvant pembrolizumab and radiation
1 AND 3 YEAR
1 AND 3 YEAR
Disease free survival in resected high risk patients treated with adjuvant pembrolizumab and chemoradiation
1 AND 3 YEAR
1 AND 3 YEAR

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Oral Squamous Cell Carcinoma by sharing your contact details with the study coordinator.