Not recruiting

Study of Durvalumab, Tremelimumab, and Cisplatin for Patients with Resectable, Locally Advanced Squamous Cell Carcinoma of the Oral Cavity

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called squamous cell carcinoma of the oral cavity, which is a cancer that occurs in the mouth. The study is investigating the effects of two medications, Durvalumab and Tremelimumab, which are given as a solution through an intravenous infusion, meaning they are administered directly into the bloodstream through a vein. The purpose of the study is to evaluate how these medications affect the cancer cells in the body.

Participants in the study will receive either Durvalumab alone or a combination of Durvalumab and Tremelimumab. The study will also include a group that receives a placebo. The trial will monitor the biological response of the tumor to these treatments. This means researchers will look at how the cancer cells react to the medications, including any changes in the tumor's size or behavior. The study will also assess the safety of the treatments and their impact on the participants' overall health.

The trial will take place over a period of time, during which participants will receive the treatments and undergo various tests and evaluations. These may include imaging tests like PET/MR scans, which help visualize the inside of the body, and assessments of the participants' health and well-being. The study aims to gather information that could lead to better treatment options for people with this type of cancer in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit and consent
Upon joining the study, the first step involves an initial visit where detailed information about the trial is provided. This includes the purpose, procedures, potential risks, and benefits. It is essential to understand this information thoroughly.
A written informed consent form must be signed to confirm understanding and willingness to participate in the study. This consent is necessary before any trial-related procedures can begin.
Step 2
Screening and eligibility assessment
A series of tests and assessments are conducted to ensure eligibility for the trial. These include medical history review, physical examination, and laboratory tests to confirm the diagnosis of resectable, locally advanced squamous cell carcinoma of the oral cavity.
Eligibility criteria include being 18 years or older, having no prior systemic therapy for the disease, and meeting specific health and organ function requirements.
Step 3
Treatment phase
The treatment phase involves receiving medications through intravenous infusion. The medications used are tremelimumab, durvalumab, and cisplatin. Each medication is administered as a solution for infusion.
The specific dosage, frequency, and duration of administration are determined by the study protocol and will be explained by the healthcare team. Regular monitoring and assessments are conducted during this phase to evaluate the response to treatment.
Step 4
Follow-up and monitoring
After the treatment phase, follow-up visits are scheduled to monitor health and assess the effects of the treatment. These visits may include physical exams, imaging tests, and laboratory tests.
The follow-up period is crucial for evaluating the long-term effects and safety of the treatment. It is important to attend all scheduled appointments and report any side effects or concerns to the healthcare team.
Step 5
End of study
The study concludes with a final assessment to gather comprehensive data on the treatment's effectiveness and safety. This may involve additional tests and evaluations.
Participants are provided with information about the study's findings and any further steps or recommendations for ongoing care.

Who can join the trial?

17 criteria

Must be at least 18 years old.
Must have a newly diagnosed disease.
Must provide written informed consent before any study procedures.
Must have a confirmed diagnosis of resectable locally advanced stage IV squamous cell carcinoma of the oral cavity. This means the cancer can be surgically removed and is in an advanced stage.
Must not have had any prior systemic therapy for head and neck cancer. Systemic therapy refers to treatments that affect the entire body, like chemotherapy.
Must not have had any prior radiation therapy in the head and neck area.
Must not have an active second cancer in the last five years, except for certain types of skin cancer or carcinoma in situ, which is a very early stage of cancer.
Must be able and willing to provide a new tumor sample for analysis.
Must have an ECOG performance status of 0 or 1. This is a scale that measures how well a person can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
Must weigh more than 30 kg (about 66 pounds).
Must not have had prior exposure to immune-mediated therapy, which includes certain types of cancer treatments that use the immune system to fight cancer.
Must have adequate organ and bone marrow function, which includes specific blood counts and liver and kidney function tests.
Must have adequate heart function as shown by an ECG, which is a test that records the electrical activity of the heart.
Women who can become pregnant must use effective birth control during the study and for 6 months after stopping treatment. Men should not father a child during the study and for 6 months after because the drugs might affect an unborn baby.
Must not participate in another clinical trial involving drugs or devices for up to 4 weeks after the study treatment.
Must not have any psychological, family, social, or geographical issues that could interfere with following the study schedule. These should be discussed before joining the trial.
Must provide written informed consent according to international and local regulations before joining the trial.

Who cannot join the trial?

10 criteria

Patients who have a different type of cancer than the one being studied.
Patients who have had another cancer treatment recently.
Patients with an active infection that needs treatment.
Patients who are pregnant or breastfeeding.
Patients with a history of severe allergic reactions to similar medications.
Patients with an autoimmune disease, which is when the body's defense system attacks its own cells.
Patients who have received a live vaccine within 30 days before the start of the study.
Patients with uncontrolled medical conditions that could interfere with the study.
Patients who are participating in another clinical trial at the same time.
Patients who have a history of drug or alcohol abuse that could affect their ability to participate in the study.

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Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium

Trial locations

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Investigated drugs

Durvalumab
is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, durvalumab is being used to see how it affects the tumor in patients with a specific type of oral cancer.
Tremelimumab
is another immunotherapy drug that is being tested in combination with durvalumab. It also helps the immune system fight cancer by targeting different pathways than durvalumab. The goal of using both medications together is to see if they can work better than durvalumab alone in treating the cancer.

What is already known about the treatment

Durvalumab
Durvalumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in medical research for its effectiveness in treating resectable, locally advanced squamous cell carcinoma of the oral cavity. The main therapeutic indication for durvalumab is to help the immune system recognize and attack cancer cells. At the molecular level, it works by blocking a protein called PD-L1, which can prevent the immune system from attacking cancer cells. Durvalumab is classified as an immune checkpoint inhibitor, a type of drug that helps the immune system fight cancer.
Tremelimumab
Tremelimumab is also administered as an intravenous infusion, similar to durvalumab. It is being investigated in combination with durvalumab for its potential to treat resectable, locally advanced squamous cell carcinoma of the oral cavity. The primary therapeutic use of tremelimumab is to enhance the body's immune response against cancer cells. It works by targeting a protein called CTLA-4, which normally helps keep the immune system in check, thereby allowing the immune system to attack cancer cells more effectively. Tremelimumab is classified as an immune checkpoint inhibitor, which is a type of medication that boosts the immune system's ability to fight cancer.

Investigated diseases

Squamous Cell Carcinoma of the Oral Cavity – Squamous cell carcinoma of the oral cavity is a type of cancer that originates in the flat, thin cells lining the lips and inside of the mouth. It typically begins as a small, painless sore or lump that may not heal. As the disease progresses, it can cause difficulty in swallowing, changes in speech, and persistent mouth pain. The cancer can invade nearby tissues and spread to lymph nodes in the neck. Over time, it may affect the ability to eat and speak. The progression of the disease can lead to significant changes in the structure and function of the oral cavity.