This clinical trial is focused on studying a type of cancer called Head and Neck Squamous Cell Carcinoma (HNSCC), which affects areas such as the mouth, throat, and voice box. The study is investigating a treatment called Dostarlimab, which is a medication given through an infusion into the vein. The purpose of the study is to evaluate how effective Dostarlimab is when used after patients have already received a combination of chemotherapy and radiation therapy, known as chemoradiation, compared to a placebo. This study is specifically for patients whose cancer is locally advanced and cannot be removed by surgery.
Participants in the study will receive either Dostarlimab or a placebo after completing their initial treatment with chemoradiation. The study will monitor the participants over a period to see how well the treatment works in preventing the cancer from coming back or spreading. The study will also look at the overall survival of participants and any side effects they may experience. The trial aims to provide more information on whether Dostarlimab can be a beneficial treatment option for patients with this type of cancer.
Throughout the study, participants will have regular check-ups and tests to monitor their health and the status of their cancer. The study will continue for several years to gather enough information to determine the effectiveness and safety of Dostarlimab as a treatment option for Head and Neck Squamous Cell Carcinoma. This research could potentially lead to new treatment strategies for patients with this challenging condition.
1Joining the study
Upon joining the study, participation is confirmed through a signed informed consent form. Eligibility is based on specific criteria, including age and medical condition.
2Initial assessment
An initial assessment is conducted to confirm the diagnosis of locally advanced, unresected head and neck squamous cell carcinoma. This includes a review of medical history and completion of chemoradiation therapy.
3Randomization
Participants are randomly assigned to receive either the study medication, dostarlimab, or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.
4Treatment administration
The study medication, dostarlimab, is administered as a solution for infusion through an intravenous route. The dosage is 500 mg, and the frequency and duration of administration are determined by the study protocol.
5Monitoring and follow-up
Regular monitoring is conducted to assess the response to treatment and any side effects. This includes physical examinations, imaging studies, and laboratory tests.
6Completion of study participation
Upon completion of the treatment phase, participants undergo a final assessment to evaluate the overall outcome and any long-term effects.
Who Can Join the Study?
Must be at least 18 years old or the legal age of consent in the area where the study is happening.
Must have a newly diagnosed head and neck cancer that cannot be removed by surgery, specifically in the oral cavity, oropharynx, hypopharynx, or larynx. Must have completed treatment with cisplatin and radiotherapy aimed at curing the cancer, with no signs of the cancer spreading to distant parts of the body.
The cancer must be classified as follows:
For oropharyngeal cancer that is p16 positive: Tumor size T4 (with or without lymph node involvement), no distant spread; or lymph node involvement N3 (any tumor size), no distant spread.
For oropharyngeal cancer that is p16 negative: Any tumor size T3-T4 (with or without lymph node involvement), no distant spread; or lymph node involvement N2a-N3 (any tumor size), no distant spread.
For cancer in the larynx, hypopharynx, or oral cavity (regardless of p16 status): Any tumor size T3-T4 (with or without lymph node involvement), no distant spread; or lymph node involvement N2a-N3 (any tumor size), no distant spread. Tumors in the oral cavity must be inoperable.
Must have received a minimum amount of treatment with cisplatin and radiotherapy:
For cisplatin: At least 200 mg/m², given either every three weeks or weekly.
For radiotherapy: A total dose of 65 to 70 Gy over 6 to 7 weeks.
Must provide a biopsy showing a tumor that is positive for PD-L1, a protein that can affect the immune system’s response to cancer. If the cancer is in the oropharynx, it must also be tested for HPV (human papillomavirus) and show a certain level of positivity.
Participants with HIV infection can join if they meet these conditions:
Have a stable and low level of HIV in the blood for at least 3 months before and at the time of screening.
Have a CD4 cell count (a type of white blood cell important for the immune system) of at least 350 cells/mm³ for the past year and at screening.
Have been on a consistent HIV treatment plan for at least 3 months before screening.
Must not have had HIV-related non-Hodgkin lymphoma or invasive cervical cancer in the past 5 years.
Must not have received an HIV-1 vaccine within 90 days before screening.
Who Cannot Join the Study?
Patients with other types of cancer that are not related to the head and neck.
Patients who have had surgery to remove their head and neck cancer.
Patients who do not have a specific protein called PD-L1 in their cancer cells. This protein can affect how the immune system responds to cancer.
Patients who are not in the age range specified for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.
Patients who have not completed a treatment called CRT, which stands for Chemoradiotherapy. This is a combination of chemotherapy and radiation therapy used to treat cancer.
Patients who are not able to follow the study procedures or take the study medication as required.
Dostarlimab is a medication being studied for its effectiveness in treating patients with a specific type of head and neck cancer that cannot be removed by surgery. It is used after patients have received a combination of chemotherapy and radiation therapy. The goal is to see if dostarlimab can help improve outcomes for patients with this type of cancer.
Head and Neck Neoplasms – These are abnormal growths that occur in the head and neck region, which can include areas such as the throat, larynx, nose, sinuses, and mouth. They often begin in the squamous cells that line the moist surfaces inside the head and neck. As these neoplasms progress, they can invade nearby tissues and spread to other parts of the body. Symptoms may include lumps, sores that do not heal, difficulty swallowing, and changes in voice. The progression can vary depending on the specific location and type of neoplasm. Early detection is crucial for managing the disease effectively.
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