Study of Monalizumab and Cetuximab for Patients with Recurrent or Metastatic Head and Neck Cancer Previously Treated with an Immune Checkpoint Inhibitor

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What is this study about?

This clinical trial is focused on studying a type of cancer called Squamous Cell Carcinoma of the Head and Neck that has either returned or spread to other parts of the body. The study involves patients who have previously been treated with a type of medicine known as an immune checkpoint inhibitor. The trial is testing a new treatment combination to see if it can help these patients live longer. The treatment being studied includes a medicine called Monalizumab, which is given together with another medicine called Cetuximab. Monalizumab is also known by its code name, IPH2201. Some patients will receive a placebo instead of Monalizumab, but all patients will receive Cetuximab.

The purpose of the study is to compare the effects of the combination of Monalizumab and Cetuximab with the combination of placebo and Cetuximab. The study will look at how long patients live after starting the treatment. Participants will be randomly assigned to one of the two groups: one group will receive Monalizumab and Cetuximab, and the other group will receive a placebo and Cetuximab. The study will be conducted in a way that neither the participants nor the researchers know who is receiving Monalizumab or the placebo, which is known as a double-blind study.

Throughout the study, participants will receive their assigned treatments through an infusion, which means the medicine is given directly into a vein. The study will also involve regular check-ups and tests to monitor the participants’ health and the effects of the treatment. These tests may include blood tests and other assessments to check for any side effects and to measure the concentration of Monalizumab in the blood. The study aims to provide valuable information on whether the new treatment combination can improve survival for patients with this type of cancer.

1 randomization

Upon joining the study, participants are randomly assigned to one of two groups. This process is called randomization.

Group A receives monalizumab and cetuximab, while Group B receives a placebo and cetuximab.

2 treatment administration

Participants receive their assigned treatment through an intravenous infusion. This means the medication is delivered directly into the bloodstream through a vein.

Monalizumab and cetuximab are administered as a solution for infusion. The frequency and dosage are determined by the study protocol and the healthcare team overseeing the trial.

3 monitoring and assessments

Throughout the trial, participants undergo regular monitoring to assess their health and the effects of the treatment.

This includes measuring the concentration of monalizumab in the blood, checking for antibodies to monalizumab, and evaluating specific biomarkers in tumor samples.

Participants also complete questionnaires about their wellbeing and any changes in symptoms.

4 evaluation of treatment effects

The primary goal is to compare overall survival between the two groups. Overall survival is defined as the time from randomization until death from any cause.

Secondary evaluations include progression-free survival, which measures the time until the disease worsens or the participant passes away, and overall response rate, which assesses the proportion of participants with a significant reduction in tumor size.

5 safety assessments

Safety is continuously monitored through assessments of adverse events, vital signs, laboratory results, and electrocardiograms (ECGs).

These assessments help ensure that any potential side effects are identified and managed promptly.

Who Can Join the Study?

Must be 18 years or older.
Have recurrent or metastatic squamous cell carcinoma of the head and neck. This means the cancer has come back or spread to other parts of the body, and it started in areas like the mouth, throat, or voice box.
Have been treated with a PD-(L)1 inhibitor. This is a type of medicine that helps the immune system fight cancer.
Have experienced prior platinum failure. This means that previous treatment with a platinum-based drug did not work.
Have received 1 or 2 previous treatments for the recurrent or metastatic cancer.
Have at least one measurable lesion at the start of the study. A lesion is an area of abnormal tissue, and it must be measurable according to specific guidelines called RECIST 1.1.
Provide a fresh or recently acquired tumor tissue sample for testing. This is needed to study certain markers in the tumor.
Have a WHO/ECOG performance status of 0 or 1. This is a scale that measures how well a person can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but still able to do light work.

Who Cannot Join the Study?

Patients who have not been previously treated with an immune checkpoint inhibitor. An immune checkpoint inhibitor is a type of drug that helps the immune system fight cancer.
Patients with conditions other than recurrent or metastatic squamous cell carcinoma of the head and neck. This is a type of cancer that has come back or spread to other parts of the body.
Patients who are related to HPV. HPV stands for human papillomavirus, a virus that can cause certain types of cancer.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial groups.
Patients who are not considered part of the vulnerable population selected for the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Universitaet Leipzig	Leipzig	Germany

Other Sites

Site Name	City	Country	Status
Udlejgzvnnfdaxsnfgxok Wlotbhkxu Arv	Wuerzburg	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	02.10.2020

Trial locations

Investigated drugs:

Monalizumab is an investigational medication being studied for its potential to help the immune system fight cancer. It is being tested in combination with another medication to see if it can improve survival in patients with certain types of head and neck cancer.

Cetuximab is a medication used to treat certain types of cancer, including head and neck cancer. It works by targeting specific proteins on the surface of cancer cells, which can help slow down or stop their growth. In this study, it is used in combination with another medication to evaluate its effectiveness in improving patient outcomes.

Investigated diseases:

Head and neck cancer

Squamous Cell Carcinoma of the Head and Neck – This is a type of cancer that originates in the squamous cells, which are flat cells found in the lining of the head and neck region, including areas such as the mouth, throat, and nose. It often begins as a small, painless growth or sore that does not heal and may bleed. As the disease progresses, it can cause symptoms like difficulty swallowing, changes in voice, or persistent sore throat. The cancer can spread to nearby tissues, lymph nodes, or other parts of the body. Recurrent or metastatic forms of this carcinoma indicate that the cancer has returned after treatment or has spread to distant parts of the body. This condition is often associated with risk factors such as tobacco use, alcohol consumption, and certain viral infections.

Trial ID:

2024-511813-39-00

Protocol code:

D7310C00001

NCT ID:

NCT04590963

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Monalizumab and Cetuximab for Patients with Recurrent or Metastatic Head and Neck Cancer Previously Treated with an Immune Checkpoint Inhibitor

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?