Study of Atezolizumab and Tiragolumab for Patients with Recurrent or Metastatic PD-L1 Positive Head and Neck Squamous Cell Carcinoma

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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 (SCCHN). This cancer affects areas such as the throat, mouth, and voice box. The study is testing two treatments: one is a combination of two medications, atezolizumab and tiragolumab, and the other is atezolizumab combined with a placebo. Atezolizumab is a medication that helps the immune system fight cancer, and tiragolumab is being studied to see if it can enhance this effect.

The purpose of the study is to evaluate how effective these treatments are in patients whose cancer has returned or spread and is positive for a protein called PD-L1. Participants will receive the treatments through an intravenous (IV) infusion, which means the medication is given directly into a vein. The study will last for up to 24 months, during which time the response to the treatment will be monitored. This includes checking how well the cancer responds to the treatment and how long the response lasts.

Throughout the study, researchers will also look at other important factors, such as how long patients live without the cancer getting worse, overall survival rates, and any side effects experienced. The study aims to provide valuable information on the potential benefits of combining atezolizumab with tiragolumab for treating this type of cancer.

1 initial treatment phase

The study involves two main treatments: atezolizumab and tiragolumab. Atezolizumab is administered as a 1,200 mg concentrate for solution, and tiragolumab is provided as a concentrate for solution for infusion.

Both medications are given through an IV infusion (intravenous infusion), which means they are delivered directly into the bloodstream through a vein.

The treatment is designed for patients with recurrent or metastatic squamous cell carcinoma of the head and neck that is positive for PD-L1, a protein that can affect the immune system’s response to cancer.

2 randomization and blinding

Participants are randomly assigned to one of two groups: one receiving atezolizumab plus tiragolumab, and the other receiving atezolizumab plus a placebo.

The study is double-blind, meaning neither the participants nor the researchers know which treatment each participant is receiving. This helps to ensure unbiased results.

3 treatment administration

The medications are administered at regular intervals as specified by the study protocol. The exact frequency and duration of administration are determined by the study’s design and the participant’s response to treatment.

Participants are monitored for their response to the treatment, including any changes in their condition and any side effects experienced.

4 monitoring and evaluation

Throughout the study, participants undergo regular assessments to evaluate the effectiveness of the treatment. This includes measuring the objective response rate, which is the proportion of patients whose cancer shrinks or disappears after treatment.

Secondary evaluations include the duration of response, progression-free survival, overall survival, and the incidence and severity of any adverse events.

5 end of study

The study is expected to conclude by February 12, 2025. At the end of the study, the data collected will be analyzed to determine the efficacy and safety of the treatments.

Participants may be asked to attend a final follow-up visit to assess their overall health and any long-term effects of the treatment.

Who Can Join the Study?

The patient must have a type of cancer called squamous cell carcinoma of the head and neck (SCCHN) that has come back or spread to other parts of the body and cannot be cured with local treatments.
The patient must have test results showing whether they have a virus called human papillomavirus (HPV) if their cancer is in the oropharynx, which is part of the throat.
The patient should not have received any previous treatments that affect the whole body for their cancer that has spread or come back.
The patient must have a cancer that can be measured using specific criteria called Response Evaluation Criteria in Solid Tumors version 1.1.
The patient’s tumor must show a certain level of a protein called PD-L1, which is checked using a test called PD-L1 IHC assay. This can be done on a previous sample or a new sample taken during the study screening.
The patient must have a performance status of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) Performance Status, which means they are fully active or have some symptoms but can still do light work.
The patient must have adequate blood and organ function, meaning their blood and organs are working well enough to participate in the study.
The study is open to both male and female patients.
The study includes patients who are considered part of a vulnerable population, meaning they may need extra protection or care.

Who Cannot Join the Study?

Patients with other types of cancer besides squamous cell carcinoma of the head and neck (SCCHN) cannot participate. This type of cancer affects the flat cells lining the head and neck area.
Patients who have received certain treatments for their cancer recently may not be eligible. This includes treatments like chemotherapy or radiation therapy.
Patients with serious heart conditions or other major health issues might be excluded to ensure their safety during the trial.
Patients who are pregnant or breastfeeding are not allowed to participate to protect the health of the mother and baby.
Patients who are unable to follow the study procedures or attend regular visits may not be eligible.
Patients with a history of severe allergic reactions to similar medications used in the study may be excluded.
Patients with active infections, such as hepatitis or HIV, might not be eligible to ensure their safety and the safety of others.
Patients who are currently participating in another clinical trial may not be allowed to join this study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Masarykuv Onkologicky Ustav	Brno-Stred	Czechia
University Of Pecs	Pecs	Hungary
Centre Francois Baclesse	Caen	France
Iqglllnx Rzlaginh Dc Cctlzy Do Msetwgjfyht	Montpellier	France
Cjtifv Lrna Braaln	Lyon	France
Iktpomoh Cftmbm Doeqavjherwwceqcl	L'hospitalet De Llobregat	Spain
Uqrjlvvwehdbpo Cjdihog Kjlpafdvx	Gdansk	Poland
Hpooxvys Uuiifzujibjmc Hpguhtac Txotv y Pystow Iguvffzi Cuxlrg dlumvxegmyqfzabey (jdyj	Badalona	Spain
Uscqiogljh Gdtyofc Hmtqkvvn Adxceyf	Athens	Greece
Iazwnruv Cvlll	Paris	France

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	10.03.2021
France	Not recruiting	10.03.2021
Greece	Not recruiting	10.03.2021
Hungary	Not recruiting	10.03.2021
Poland	Not recruiting	10.03.2021
Spain	Not recruiting	10.03.2021

Trial locations

Investigated drugs:

Atezolizumab

Atezolizumab is a medication used in this trial as part of the treatment for patients with a specific type of head and neck cancer. It works by helping the immune system to detect and fight cancer cells more effectively. Atezolizumab is often used in combination with other medications to enhance its effectiveness.

Tiragolumab is another medication used in this trial alongside atezolizumab. It is designed to work with the immune system to target and destroy cancer cells. Tiragolumab is being studied to see if it can improve the outcomes for patients when used with atezolizumab.

Squamous Cell Carcinoma of the Head and Neck (SCCHN) – This is a type of cancer that begins in the squamous cells, which are flat cells found in the lining of the head and neck region. It typically affects areas such as the mouth, throat, and nose. The disease often starts as a small, painless growth or sore that does not heal. As it progresses, it can lead to symptoms like difficulty swallowing, changes in voice, or a persistent sore throat. Over time, the cancer may spread to nearby tissues or lymph nodes. Early detection is crucial for managing the disease effectively.

Trial ID:

2023-509449-10-00

Protocol code:

BO42533

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Atezolizumab and Tiragolumab for Patients with Recurrent or Metastatic PD-L1 Positive Head and Neck Squamous Cell Carcinoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?