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Study of Retifanlimab, INCAGN02385, and INCAGN02390 for First-Line Treatment in Patients with PD-L1 Positive Recurrent/Metastatic Head and Neck Cancer

Fast replyInvestigationalNo 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 recurrent/metastatic squamous cell carcinoma of the head and neck. This cancer has returned or spread to other parts of the body and is positive for a protein called PD-L1. The study is testing a combination of treatments to see how effective they are in treating this cancer. The treatments being tested include Retifanlimab, which is a type of medication known as a monoclonal antibody, and two other investigational drugs, INCAGN02385 and INCAGN02390. These drugs are given as a solution through a vein, a method known as intravenous infusion.

The purpose of the study is to determine how well these combinations of treatments work compared to using Retifanlimab alone. Participants in the study will be randomly assigned to receive either Retifanlimab by itself or in combination with INCAGN02385 and/or INCAGN02390. The study will be conducted in a way that neither the participants nor the researchers will know which treatment each participant is receiving, a method known as a double-blind study. The study will last for a period of up to 24 months, during which participants will receive regular infusions and be monitored for any changes in their condition.

Throughout the study, participants will have regular check-ups to assess their health and the progress of their cancer. This will include physical exams, blood tests, and other assessments to monitor the effects of the treatment. The study aims to provide valuable information on the effectiveness of these new treatment combinations for people with this type of cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be asked to sign a document called an informed consent form. This document confirms that you understand the study and agree to participate.

    You must be at least 18 years old and have a specific type of cancer called recurrent or metastatic squamous cell carcinoma of the head and neck. Your tumor must be positive for a protein called PD-L1.

  2. Step 2

    Initial assessments

    Before starting the treatment, several assessments will be conducted. These include a review of your medical history, a physical examination, and laboratory tests.

    You will also need to provide a sample of your tumor tissue for analysis. This can be from a previous biopsy or a new one if necessary.

  3. Step 3

    Treatment assignment

    You will be randomly assigned to one of three treatment groups. This means you will not choose which group you are in, and neither will the researchers.

    The treatments involve a medication called retifanlimab, which is given through an intravenous infusion. This means it is administered directly into your vein.

  4. Step 4

    Treatment administration

    If you are in the first group, you will receive retifanlimab alone. If you are in the second group, you will receive retifanlimab with another medication called INCAGN02385. If you are in the third group, you will receive retifanlimab, INCAGN02385, and a third medication called INCAGN02390.

    These medications are given as a solution for infusion, which means they are delivered into your bloodstream over a period of time. The frequency and duration of these infusions will be explained to you by the study team.

  5. Step 5

    Ongoing assessments

    Throughout the study, you will have regular check-ups to monitor your health and the effects of the treatment. This includes physical exams, blood tests, and imaging tests to check the status of your cancer.

    You will also be asked about any side effects you experience. It is important to report any new symptoms or changes in your health to the study team.

  6. Step 6

    End of treatment

    The treatment will continue until your doctor decides it is no longer beneficial, you experience unacceptable side effects, or you choose to stop participating.

    After the treatment ends, you will have a final assessment to evaluate your overall health and the outcome of the treatment.

Who can join the trial?

9 criteria

  • Ability to understand and willingness to sign a written consent form for the study.
  • Must be 18 years or older at the time of signing the consent form.
  • Must have a confirmed diagnosis of R/M SCCHN (a type of head and neck cancer) that cannot be treated with surgery or radiation aimed at curing the disease. If you refuse surgery that could potentially cure recurrent disease, you cannot participate.
  • Must have a PD-L1 positive tumor, which means a specific protein is present in the tumor, as determined by a central laboratory.
  • If the primary tumor is in the oropharynx (part of the throat), documentation of HPV p16 status (a test to check for a virus linked to cancer) is required. This is not needed for tumors in other head and neck areas.
  • Must have at least one tumor that can be measured according to specific medical guidelines (RECIST v1.1).
  • Must have available tissue samples from a previous biopsy for biomarker analysis or be willing to undergo a new biopsy.
  • Must have an ECOG performance status of 0 or 1, which means you are fully active or have some symptoms but can carry out light work.
  • Must be willing to avoid pregnancy or fathering children during the study, based on specific criteria.

Who cannot join the trial?

4 criteria

  • Participants who have already received systemic therapy for their condition. (Systemic therapy is a treatment that uses substances that travel through the bloodstream, reaching and affecting cells all over the body.)
  • Participants who do not have a PD-L1 positive status. (PD-L1 is a protein that can be found on the surface of cells, and its presence can affect how the immune system responds to cancer.)
  • Participants who are not within the specified age range for the study.
  • Participants who are considered part of a vulnerable population. (Vulnerable populations may include groups like children, pregnant women, or those unable to give consent.)
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Investigated drugs

  • Retifanlimab

    is a type of medication known as an immune checkpoint inhibitor. It works by helping the body's immune system recognize and attack cancer cells. In this trial, retifanlimab is being used to treat a type of cancer called squamous cell carcinoma of the head and neck. The goal is to see if it can help slow down or stop the growth of cancer cells.

  • INCAGN02385

    is an experimental medication that targets a protein called LAG-3. This protein can sometimes prevent the immune system from attacking cancer cells. By blocking LAG-3, INCAGN02385 may help the immune system better fight the cancer. In this study, it is being tested in combination with other medications to see if it can improve treatment outcomes for patients with head and neck cancer.

  • INCAGN02390

    is another experimental medication being tested in this trial. It targets a protein called TIM-3, which can also interfere with the immune system's ability to attack cancer cells. By blocking TIM-3, INCAGN02390 may enhance the immune response against cancer. This medication is being studied in combination with others to determine if it can help improve the effectiveness of cancer treatment.

What is already known about the treatment

Retifanlimab – Retifanlimab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials as a treatment for people with a specific type of head and neck cancer that has returned or spread and has not been treated with systemic therapy before. The medication works by blocking a protein called PD-1, which helps the immune system recognize and attack cancer cells. Retifanlimab is classified as an immune checkpoint inhibitor, a type of drug that helps the body's immune system fight cancer.

Investigated diseases

Squamous Cell Carcinoma of the Head and Neck (SCCHN) – This is a type of cancer that originates in the squamous cells lining the moist surfaces inside the head and neck, such as the mouth, nose, and throat. It typically begins as a small, localized growth that can gradually invade surrounding tissues. As the disease progresses, it may spread to nearby lymph nodes and other parts of the body. The progression can lead to symptoms such as persistent sore throat, difficulty swallowing, and changes in voice. Over time, the cancer can cause more severe symptoms and complications as it affects additional areas. The rate of progression can vary based on factors like the location of the tumor and the individual's overall health.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504270-38-00Protocol codeINCAGN 2385-203Estimated enrolment176 patientsSponsorIncyte Biosciences International S.a.r.l.

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