Pembrolizumab for Mouth Cancer

Overseen By Adam Burr, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Must be taking: Pembrolizumab

Must not be taking: Corticosteroids, Immunosuppressants, Anti-PD-1

Disqualifiers: Auto-immune disease, Pregnancy, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a personalized tumor system, created in a lab, can accurately predict how a patient's mouth cancer will respond to pembrolizumab, a common cancer treatment. Participants will receive pembrolizumab and undergo a biopsy to help researchers learn more about this process. This trial suits those with mouth cancer ready for surgery who have not received chemotherapy or immunotherapy for this condition before.

As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could personalize cancer treatment in the future.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, you cannot have received prior chemotherapy or immunotherapy for oral cavity cancer, and you must not require systemic treatment doses of corticosteroids or other immunosuppressive drugs.

Is there any evidence suggesting that pembrolizumab is likely to be safe for humans?

Research shows that pembrolizumab, the treatment under study in this trial, is generally well-tolerated. Studies have found it effective for some patients with head and neck cancers. Like all treatments, it can cause side effects, but these are usually manageable. Common side effects might include fatigue or nausea, typical of many cancer treatments.

The FDA has approved pembrolizumab for other types of cancer, indicating a strong safety record. While side effects can occur, the treatment is considered safe for patients with certain conditions. Discuss any concerns with a doctor, but evidence supports that pembrolizumab is generally a safe option for many patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for mouth cancer, which typically involve surgery, radiation, or chemotherapy, pembrolizumab offers a different approach by harnessing the body's immune system to fight the cancer. Pembrolizumab is a type of immunotherapy known as a PD-1 inhibitor. It works by blocking a protein on cancer cells that usually helps them hide from the immune system, allowing the body to better detect and attack the cancer. Researchers are excited about pembrolizumab because it has shown promise in other cancers and could offer a less invasive option with potentially fewer side effects compared to traditional therapies.

What is the effectiveness track record for pembrolizumab in treating mouth cancer?

Research has shown that pembrolizumab effectively treats head and neck cancer, including mouth cancer. Studies found that patients with certain markers (CPS ≥ 20) lived for a median of 14.6 months when treated with pembrolizumab. Other studies demonstrated that combining pembrolizumab with chemotherapy extended patients' lives compared to other treatments. The FDA has approved pembrolizumab for some types of head and neck cancer, confirming its effectiveness. In some cases, it also reduced the risk of cancer spreading to other parts of the body. Participants in this trial will receive pembrolizumab as part of the standard of care. ^{1 3 5 6 7}

Who Is on the Research Team?

Adam Burr, MD, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

Adults over 18 with stage II-IVB oral cavity cancer, who haven't had chemo or immunotherapy for it. They must be able to undergo a biopsy, have an ECOG status of 0-2, and agree to contraception if of childbearing potential. Those with prior unrelated cancer treatments must be 30+ days post-treatment.

Inclusion Criteria

I can care for myself and am up and about more than 50% of my waking hours.

I haven't had chemo or immunotherapy for oral cancer but finished other cancer treatments over a month ago.

I agree to use birth control during and for 100 days after the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Immunotherapy

Participants receive pembrolizumab as part of the standard of care prior to surgery

8 weeks

Pembrolizumab administered once per standard of care

Biomarker Analysis

Biomarkers are studied using single cell RNA sequencing and a patient-specific culture vessel

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pembrolizumab

Trial Overview

The trial is testing the creation of a patient-specific tumor culture vessel to predict treatment response and administering pembrolizumab before surgery. The study aims to see if this approach can help tailor individual care.

How Is the Trial Designed?

Group I: Standard of Care: Pembrolizumab Experimental Treatment 2 Interventions

Participants receive pembrolizumab by a needle (IV) in the arm once per standard of care (SOC)

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10910039/

The clinical outcome of pembrolizumab for patients with ...

In patients with CPS ≥ 20, the median OS was 14.6 months, and the median OS was 12.33 month. These findings are basically consistent with the ...

2.

fda.gov

fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-first-line-treatment-head-and-neck-squamous-cell-carcinoma

FDA approves pembrolizumab for first-line treatment of ...

The median OS was 13.0 months for the pembrolizumab plus chemotherapy arm and 10.7 months for the cetuximab plus chemotherapy arm (HR 0.77; 95% ...

3.

merck.com

merck.com/news/fda-approves-keytruda-pembrolizumab-for-pd-l1-resectable-locally-advanced-head-neck-squamous-cell-carcinoma-as-neoadjuvant-treatment-continued-as-adjuvant-treatment-combined-with-radiother/

FDA Approves KEYTRUDA® (pembrolizumab) for PD-L1+ ...

Among the CPS ≥1 population, median EFS was 59.7 months (95% CI, 37.9-not reached) in the KEYTRUDA arm versus 29.6 months (95% CI, 19.5-41.9) in ...

4.

keytruda.com

keytruda.com/head-and-neck-cancer/clinical-trial-results-with-chemotherapy/

KEYTRUDA used with chemotherapy as first treatment

Half of the people who received KEYTRUDA and chemotherapy were alive without their cancer spreading, growing, or getting worse at 4.9 months, compared to 5.1 ...

5.

icr.ac.uk

icr.ac.uk/about-us/icr-news/detail/immunotherapy-gives-head-and-neck-cancer-patients-extra-years-disease-free

Immunotherapy gives head and neck cancer patients extra ...

After three years, patients given pembrolizumab had a ten per cent reduced risk of their cancer returning elsewhere in the body – indicating that the immune ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10229243/

Efficacy and Safety of Pembrolizumab Monotherapy for ...

Our study suggests that pembrolizumab is beneficial to the most responsive patients with R/U/M OSCC in our single-center study and may shed light on the ...

7.

keytrudahcp.com

keytrudahcp.com/efficacy/

Efficacy Data for KEYTRUDA® (pembrolizumab)

Health care professionals may review efficacy data for KEYTRUDA® (pembrolizumab), browse the indications and select the corresponding KEYNOTE trials for ...