Study on Atezolizumab and Tiragolumab for Patients with Head and Neck Cancer, Metastatic Melanoma, and Other Advanced Solid Tumors

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What is this study about?

This clinical trial is focused on studying the effects of two medications, Tiragolumab and Tecentriq (also known as Atezolizumab), on various types of cancer. The diseases being studied include Head and Neck Squamous Cell Carcinoma (HNSCC), metastatic deficient mismatch repair (dMMR) or MSI-high (MSI-H) tumors, irresectable or metastatic melanoma, and other locally advanced or metastatic solid tumors. The purpose of the study is to evaluate how well these medications work in treating these cancers.

Participants in the study will receive the medications through an infusion, which means the drugs are given directly into the bloodstream. The study will observe how the tumors respond to the treatment over a period of time. The trial is designed to see if the combination of Tiragolumab and Tecentriq can help shrink the tumors or stop them from growing. The study will also monitor the safety of the medications and any side effects that may occur.

The trial is open-label, meaning both the researchers and participants know which treatment is being administered. The study will include different groups of patients, each with specific types of cancer, to determine the effectiveness of the treatment across various conditions. The trial aims to provide valuable information on whether these medications can be beneficial for patients with these types of cancer.

1 joining the study

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

Eligibility criteria include having a measurable disease, being 18 years or older, and having a life expectancy of at least 12 weeks. The patient must also have adequate organ and bone marrow function.

2 treatment administration

The patient will receive two medications: Tiragolumab and Atezolizumab. These medications are administered as a solution for infusion, which means they are given through a vein (intravenous use).

The specific dosage and frequency of administration will be determined by the healthcare provider based on the patient’s condition and response to treatment.

3 monitoring and assessments

Throughout the trial, the patient will undergo regular monitoring to assess the response to treatment. This includes physical examinations, laboratory tests, and imaging studies such as CT or MRI scans.

The primary goal is to evaluate the pathologic response of the primary tumor and overall response rates in various cancer types.

4 safety evaluations

Safety assessments will be conducted to monitor any adverse events or side effects from the treatment. These will be graded according to established criteria.

Changes in laboratory test results, vital signs, and physical findings will be closely observed to ensure the patient’s safety.

5 end of trial participation

The trial is expected to continue until October 2026. The patient’s participation may end earlier if the treatment is no longer beneficial or if the patient chooses to withdraw.

Upon completion of the trial, the patient will have a final assessment to evaluate the overall outcomes and any long-term effects of the treatment.

Who Can Join the Study?

The patient must have a tumor that can be safely biopsied, which means a small sample of the tumor can be taken for examination.
If the patient is a woman who can have children or a man with a partner who can have children, they must agree to use a very effective form of birth control.
For patients with head and neck cancer, specific conditions apply:
- The cancer must be of a certain size or have spread to nearby lymph nodes but not to distant parts of the body.
- The patient must not have had radiation treatment to the head and neck area before.
The patient must have a disease that can be measured using specific medical guidelines. Areas that have been treated with radiation before should not be used for measurement.
The patient must participate in a specific imaging trial if there are available spots.
The patient must sign a document agreeing to participate in the study, known as informed consent.
The patient must be at least 18 years old when they sign the informed consent.
The patient must have a life expectancy of at least 12 weeks.
The patient must have a good level of daily functioning, as measured by a specific scale called the Eastern Cooperative Oncology Group (ECOG) performance status, which should be 0 or 1.
The patient must have proper functioning of organs and bone marrow, which includes:
- Hemoglobin levels of at least 9.0 grams per deciliter.
- Platelet count of at least 100 billion per liter.
- Kidney function within a certain range, measured by serum creatinine or a specific filtration rate.
- Liver function within certain limits, with specific allowances for patients with a condition called Gilbert’s syndrome.
- Levels of certain liver enzymes (AST, ALT, ALP) within specified limits, with higher limits if there is liver or bone involvement.
The patient must be able to follow the study’s procedures and requirements.

Who Cannot Join the Study?

Patients who have a type of cancer that is not included in the study, such as those not having HNSCC (a type of head and neck cancer), dMMR/MSI-H tumors (tumors with specific genetic features), or melanoma (a type of skin cancer).
Patients whose cancer is not in an advanced or metastatic stage. Metastatic means the cancer has spread to other parts of the body.
Patients who have a cancer that can be surgically removed. Irresectable means the cancer cannot be removed with surgery.
Patients who are not considered by the investigator to potentially benefit from the study treatment based on available clinical data.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Uxijbridyqey Mttpalh Cvdvvbt Gyzmbxqnw	Groningen	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	31.10.2023

Trial locations

Investigated drugs:

Atezolizumab

Atezolizumab is a medication used in this trial to help the body’s immune system fight cancer. It works by blocking a protein that can stop the immune system from attacking cancer cells, allowing the immune system to better target and destroy these cells.

Tiragolumab is another medication used in the trial alongside atezolizumab. It is designed to enhance the immune response against cancer cells by targeting a different protein that can inhibit the immune system. By blocking this protein, tiragolumab helps the immune system to more effectively attack and eliminate cancer cells.

Investigated diseases:

Head and Neck Squamous Cell Carcinoma (HNSCC) – This is a type of cancer that arises from the squamous cells lining the moist surfaces inside the head and neck. It can develop in areas such as the mouth, throat, and nose. The disease often begins as a small, localized tumor and can progress to involve nearby tissues and lymph nodes. Over time, it may spread to other parts of the body, becoming metastatic. The progression can vary greatly depending on the location and size of the tumor.

Deficient Mismatch Repair (dMMR)/Microsatellite Instability-High (MSI-H) Tumors – These are tumors characterized by genetic mutations that impair the DNA repair process, leading to increased mutation rates. They can occur in various parts of the body, including the colon, stomach, and endometrium. These tumors often grow and spread more rapidly than other types. They are known for their potential to become metastatic, affecting distant organs. The presence of dMMR/MSI-H is a key factor in the tumor’s behavior and progression.

Metastatic Melanoma – This is an advanced form of skin cancer that originates in the pigment-producing melanocytes. It is known for its aggressive nature and ability to spread to other parts of the body, such as the lungs, liver, and brain. The disease often begins as a mole or pigmented lesion on the skin. As it progresses, it can invade deeper skin layers and enter the bloodstream or lymphatic system. Metastatic melanoma is characterized by its rapid growth and potential to affect multiple organs.

Locally Advanced or Metastatic Solid Tumor – This term refers to a group of cancers that originate in solid organs or tissues and have either spread locally or to distant sites. These tumors can arise in various organs, including the lungs, liver, and pancreas. Locally advanced tumors have grown beyond their original site but have not yet spread to distant organs. Metastatic tumors have spread to other parts of the body, often through the bloodstream or lymphatic system. The progression of these tumors depends on their type, location, and genetic characteristics.

Trial ID:

2024-512616-21-00

NCT ID:

NCT05483400

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Atezolizumab and Tiragolumab for Patients with Head and Neck Cancer, Metastatic Melanoma, and Other Advanced Solid Tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?