Study of nivolumab and ipilimumab immunotherapy for organ preservation in patients with advanced head and neck squamous cell carcinoma

Initial treatment assignment

At the start of the study, you will be randomly assigned to one of two treatment groups. This process is called randomization and ensures that each patient has an equal chance of being placed in either group.

One group will receive immunotherapy treatment followed by evaluation for possible surgery. The other group will proceed directly to standard treatment, which typically involves surgery with or without additional therapy.

The assignment to a specific group is done by chance, similar to flipping a coin, and neither you nor your doctor can choose which group you will be in.

Immunotherapy treatment phase

If you are assigned to the immunotherapy group, you will receive a combination of two medications called nivolumab and ipilimumab.

Both medications are given through a vein in your arm. This method of administration is called intravenous infusion.

Nivolumab is provided as a concentrated solution at 10 milligrams per milliliter, and ipilimumab is provided as a concentrated solution at 5 milligrams per milliliter.

The infusion will be administered in a medical facility where healthcare professionals can monitor you during the treatment.

Response evaluation

After completing the immunotherapy treatment, your medical team will evaluate how your cancer has responded to the medication.

This evaluation will involve imaging scans and physical examinations to determine whether the tumor has shrunk, remained stable, or changed in any way.

Based on the results of this evaluation, your doctor will determine the next steps in your treatment plan.

Treatment decision based on response

If the immunotherapy has resulted in a complete clinical response, meaning that no visible signs of cancer can be detected during examinations, you may be able to avoid surgery and preserve the structure and function of your face and mouth.

If the cancer has not responded completely to the immunotherapy, you will proceed to receive standard treatment, which may include surgery to remove the tumor.

The decision about whether surgery is necessary will be made based on careful assessment of your individual response to treatment.

Standard treatment or continued monitoring

If you were assigned to the standard treatment group, or if you did not achieve a complete response to immunotherapy, you will undergo surgery to remove the cancer from your mouth and potentially affected lymph nodes in your neck.

After surgery, you may receive additional treatment such as radiotherapy, which uses high-energy rays to kill cancer cells, or chemoradiotherapy, which combines radiotherapy with chemotherapy medications.

If you achieved a complete response to immunotherapy and do not require surgery, you will be closely monitored through regular follow-up visits.

Follow-up assessments at 12 months

At 12 months after starting the study, you will have scheduled follow-up appointments to check for any signs of cancer recurrence.

These appointments will include physical examinations and imaging studies to ensure that the cancer has not returned.

You will also be asked to complete questionnaires about your quality of life, including questions about your physical function, emotional well-being, and any symptoms you may be experiencing.

Follow-up assessments at 18 months

At 18 months after starting the study, you will have another set of follow-up appointments similar to those at 12 months.

Your medical team will continue to monitor for any signs of cancer recurrence through examinations and imaging.

You will again complete questionnaires about your quality of life and any health-related concerns.

Follow-up assessments at 24 months

At 24 months after starting the study, you will have comprehensive follow-up assessments to evaluate your long-term outcomes.

These assessments will include examinations to check for cancer recurrence and to evaluate the preservation of the structure and function of your face and mouth.

You will complete additional quality of life questionnaires to provide information about your overall health and well-being at this time point.

The study will assess whether you have remained free of cancer recurrence and whether organ preservation was successfully achieved if you were in the immunotherapy group.

Monitoring for side effects

Throughout the study and up to 100 days after your last treatment, your medical team will monitor you for any adverse events, which are unwanted or harmful effects that may occur.

Special attention will be given to immune-related adverse events, which are side effects that can occur when immunotherapy medications affect the immune system.

Any side effects you experience will be documented and managed according to standard medical practices.

You should report any new or worsening symptoms to your medical team promptly so they can be properly evaluated and treated.

Ongoing safety monitoring

If you are a woman of childbearing potential, you will need to use appropriate contraception methods to prevent pregnancy during the study and for 23 weeks after receiving the last dose of immunotherapy medication.

Regular laboratory tests will be performed throughout the study to monitor your blood counts, kidney function, and liver function.

Your overall health status and ability to perform daily activities will be regularly assessed using the World Health Organization performance status scale.