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Study on the Effects of IO102 Hydrochloride and IO103 Acetate for Patients with Head and Neck Cancer

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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. The study is exploring the use of new treatments called peptide-based immunotherapies. These treatments include three different combinations: IO102 + Montanide, IO103 + Montanide, and IO102 + IO103 + Montanide. These are given as an emulsion for injection, which means they are a liquid mixture that is injected under the skin.

The purpose of the study is to see how these treatments affect the body’s immune system, specifically looking at a type of immune cell called a T-cell. The study will last for about three weeks, during which participants will receive one of the treatments before starting their standard cancer treatment. The study will monitor the safety and effects of these treatments on the cancer and the immune system.

Participants will be closely observed to see how their bodies respond to the treatment, including any changes in their cancer and any side effects they might experience. The study aims to gather information on how well these treatments work on their own before the usual cancer treatments begin. This research could help improve future treatment options for people with head and neck cancer.

1 joining the study

Upon joining the study, the participant will be informed about the trial’s objectives and procedures. The participant must provide written consent to participate in the trial.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes verifying the diagnosis of squamous cell carcinoma of the head and neck and ensuring no distant metastases are present.

3 treatment assignment

Participants will be assigned to one of three treatment groups: IO102 + Montanide, IO103 + Montanide, or IO102 + IO103 + Montanide. Each treatment is administered as an emulsion for injection under the skin (subcutaneous use).

4 treatment administration

The treatment will be administered over a period of 3 weeks. The specific schedule and dosage will be provided by the medical team.

5 monitoring and evaluation

Throughout the treatment period, participants will be monitored for safety and tolerability. This includes regular clinical laboratory tests and physical examinations.

The response to the treatment will be evaluated by measuring specific immune responses in the blood and assessing any changes in the tumor using imaging techniques such as MRI.

6 completion of treatment

After the 3-week treatment period, participants will undergo a final assessment to evaluate the overall response to the treatment and any potential side effects.

Who Can Join the Study?

  • Men and women who are 18 years or older on the day they sign the consent form.
  • Men who can father a child must agree to use birth control starting from the screening visit and throughout the trial.
  • Women can participate if they are not pregnant, not breastfeeding, and meet one of these conditions:
    • They cannot have children.
    • If they can have children, they must agree to use birth control starting from the screening and throughout the trial.
  • Must have a confirmed diagnosis of squamous cell carcinoma in the mouth, throat, or voice box. This means a type of cancer in these areas.
  • Selected for treatment that aims to cure the cancer.
  • No cancer spread to distant parts of the body.
  • Must have a measurable disease according to specific medical guidelines (RECIST 1.1).
  • No active second cancer in the last 3 years, except for certain skin cancers or a specific type of cervical cancer.
  • Must provide written consent to participate in the trial, following international and local rules.
  • Must have a good general health status, with an ECOG performance status of 0-1 and a Karnofsky score of 70 or higher. These are scales used to measure how well a person can perform daily activities.
  • Must have certain blood test results:
    • Neutrophil count greater than 1,500 per mm3.
    • Platelet count greater than 75,000 per mm3.
    • White blood cell count of 3.0 or more per 109 L.
    • Bilirubin or creatinine less than 2 times the upper limit of normal (ULN).
    • ALT or AST less than 5 times the ULN. These are liver enzymes.
    • Hemoglobin of 9 g/dL or higher.

Who Cannot Join the Study?

  • Patients who have a different type of cancer than squamous cell carcinoma of the head and neck cannot participate.
  • Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are not part of the specified clinical trial groups cannot participate. The specific group is not detailed here, but it is important for eligibility.
  • Patients who are not male or female cannot participate, as the trial includes both genders.
  • Patients who are not considered part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or those with certain disabilities, but the specific group is not detailed here.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
CHU Helora La Louviere Belgium
Csizsmede Ugcvnoylqvsvrw Sjgswvmhm Woluwe-Saint-Lambert Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
06.05.2020

Trial locations

Peptide-Based Immunotherapy is a treatment designed to stimulate the body’s immune system to fight cancer cells. In this trial, it is used to target specific proteins found on the surface of cancer cells in patients with squamous cell carcinoma of the head and neck. The goal is to enhance the immune response by training T-cells, a type of white blood cell, to recognize and attack these cancer cells more effectively.

Investigated diseases:

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. It typically begins in the mucous membranes of the mouth, nose, and throat. As the disease progresses, it can invade nearby tissues and spread to other parts of the body, including lymph nodes. Symptoms may include a persistent sore throat, difficulty swallowing, and changes in voice. The progression of the disease can vary, with some cases remaining localized while others may spread more extensively. Early detection is crucial for managing the disease effectively.

Trial ID:
2024-513447-82-00
Protocol code:
HN1901
NCT ID:
NCT04445064
Trial Phase:
Therapeutic exploratory (Phase II)

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