Study on the Safety of Tiragolumab and Atezolizumab for Patients with Advanced or Metastatic Solid Tumors

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What is this study about?

This clinical trial is focused on studying the safety and behavior of a new treatment for people with certain types of cancer known as solid tumors. These tumors can be locally advanced, which means they have grown but not spread far, or they can be recurrent, meaning they have come back after treatment, or metastatic, which means they have spread to other parts of the body. The treatment being tested is a combination of two medications, atezolizumab and tiragolumab, given together as a solution through an intravenous infusion, which is a way to deliver medicine directly into the bloodstream.

The purpose of this study is to evaluate how safe this combination treatment is and how it behaves in the body. Participants will receive the treatment and be monitored for any side effects or reactions. The study will also look at how the body processes the medications, including how much of the drug is present in the blood at different times. This will help researchers understand the treatment’s safety and how it might work in treating solid tumors.

Throughout the study, participants will receive regular check-ups and tests to monitor their health and the effects of the treatment. The study aims to gather important information that could lead to new treatment options for people with solid tumors. The trial is expected to continue until late 2025, providing valuable insights into the potential benefits and risks of this new treatment combination.

1 joining the study

Upon joining the study, participation is confirmed for individuals with specific types of solid tumors that are locally advanced, recurrent, or metastatic.

Eligibility requires a life expectancy of at least 12 weeks and measurable disease according to specific criteria.

2 treatment administration

The treatment involves a combination of two medications: tiragolumab and atezolizumab.

These medications are administered as a fixed-dose combination through an intravenous infusion.

The solution is prepared for infusion and given to the patient at specified intervals.

3 monitoring and evaluation

Throughout the study, the safety and tolerability of the treatment are closely monitored.

The primary focus is on the incidence and severity of any adverse events experienced during the trial.

Blood samples are taken to measure the concentration of the medications in the body at different times, particularly during the first cycle of treatment.

4 antibody assessment

The presence of anti-drug antibodies (ADAs) is assessed at the beginning of the study and monitored throughout.

This helps to understand if the body is developing any resistance to the medications.

5 completion of the study

The study is expected to continue until December 26, 2025.

Participants will be informed about the outcomes and any further steps after the study concludes.

Who Can Join the Study?

The patient must have a type of cancer called a solid tumor, which means the cancer forms a mass or lump in the body.
The patient must have a confirmed diagnosis of cancer that is either locally advanced (spread to nearby areas), recurrent (come back after treatment), or metastatic (spread to other parts of the body) and cannot be treated with standard local treatments.
The patient must have adequate hematologic and end organ function, meaning their blood and major organs are working well enough to participate in the study.
The patient’s tumor must be PD-L1-selected, which means it has a specific protein that can be identified by a special test called the VENTANA® PD-L1 (SP263) IHC assay. The types of tumors include esophageal adenocarcinoma (EAC), esophageal squamous cell carcinoma (ESCC), gastric cancer (GC), gastroesophageal junction cancer (GEJ), hepatocellular carcinoma (HCC), melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), squamous cell carcinoma of the head and neck (SCCHN), and urothelial bladder cancer (UBC).
The patient must have a measurable disease according to a standard called RECIST v1.1, which means the cancer can be measured in size to see if it changes during the study.
The patient must have a life expectancy of at least 12 weeks, meaning they are expected to live for at least 12 more weeks.
The patient must be within the age range of adults, which includes both male and female participants.

Who Cannot Join the Study?

Patients who have a type of cancer that is not a solid tumor. A solid tumor is a mass of tissue that does not contain liquid areas or cysts.
Patients who are not within the specified age range for the study. The study is open to certain age groups only.
Patients who are not able to receive the study medications safely. This means the doctors believe the treatment might not be safe for them.
Patients who are part of a vulnerable population that the study cannot safely include. Vulnerable populations may include groups like pregnant women or people with certain disabilities.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Hm Sanchinarro	Madrid	Spain

Other Sites

Site Name	City	Country
KBC Zagreb	Zagreb	Croatia
Hospital Del Mar	Barcelona	Spain
Euromedica General Clinic Of Thessaloniki	Thessaloniki	Greece
Hospital Clinico Universitario De Valencia	Valencia	Spain
Hospital Universitario Virgen Macarena	Sevilla	Spain
Hospital Universitario Reina Sofía	Cordoba	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Alexandra Hospital	Athens	Greece
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Bank Of Cyprus Oncology Center	Strovolos	Cyprus
General University Hospital Of Patras	Patras	Greece
St. Luke’s Hospital S.A.	Thessaloniki	Greece
Pula General Hospital Ospedale Generale di Pola	Pula	Croatia
Ivfwtvbt Cdiyth Dhfgxxiumxdtauijj	L'hospitalet De Llobregat	Spain
Ictc Guosr	Filothei	Greece
Lqfilytlc Sfjd Obex Laehyfm	Limassol	Cyprus
Hrnxgnwd Uvlsxkelabhoi Rvcpoela Da Msrmam	Malaga	Spain
Ajglfp Mzrrlex Copvlw Snhv	Thessaloniki	Greece
Hivjnrrs Vwxr ddfnglqz	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Croatia	Not recruiting	30.11.2023
Cyprus	Not recruiting	30.11.2023
Greece	Not recruiting	30.11.2023
Spain	Not recruiting	30.11.2023

Trial locations

Tiragolumab is a medication being studied for its potential to help the immune system fight cancer. It works by blocking a specific protein that can prevent the immune system from attacking cancer cells. In this trial, it is being tested in combination with another medication to see if it can improve treatment outcomes for patients with advanced or recurrent solid tumors.

Atezolizumab is an immunotherapy drug that helps the body’s immune system recognize and attack cancer cells. It targets a protein that can hide cancer cells from the immune system. In this study, atezolizumab is combined with tiragolumab to evaluate if the combination is safe and effective for treating patients with certain types of advanced cancer.

Solid Tumors – Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in various parts of the body, including organs and bones. These tumors are characterized by the uncontrolled growth of cells that form a lump or mass. As they grow, they may press on nearby structures, potentially affecting their function. Solid tumors can be benign, meaning they do not spread to other parts of the body, or malignant, which means they have the potential to invade nearby tissues and spread to distant sites. The progression of solid tumors depends on their type, location, and growth rate.

Trial ID:

2023-508489-14-00

Protocol code:

GO44096

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety of Tiragolumab and Atezolizumab for Patients with Advanced or Metastatic Solid Tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?