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Study on the Effectiveness and Safety of Tiragolumab, Atezolizumab, and Drug Combination for Patients with Urothelial Carcinoma

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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 treatments for urothelial carcinoma, a type of cancer that affects the bladder and other parts of the urinary system. The study will explore the effectiveness and safety of different combinations of immunotherapy-based treatments. The medications being tested include Tiragolumab, Tecentriq (also known as Atezolizumab), Cisplatin, and Gemcitabine Hydrochloride. These treatments are administered through an intravenous infusion, which means they are given directly into a vein.

The purpose of the study is to evaluate how well these treatments work in patients with urothelial carcinoma. The study will be conducted in stages, with the first stage focusing on patients whose cancer has spread to other parts of the body, known as metastatic urothelial carcinoma. The second stage will involve patients with muscle-invasive bladder cancer, which means the cancer has grown into the muscle layer of the bladder. The study will assess the response of the cancer to the treatments and monitor any side effects experienced by the participants.

Participants in the study will receive one or more of the treatments over a period of time, with regular check-ups to monitor their health and the progress of the cancer. The study aims to provide valuable information on the potential benefits and risks of these immunotherapy-based treatments for patients with urothelial carcinoma. The trial is expected to continue until 2027, with the goal of improving treatment options for 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.

Step 1
Joining the study
Upon joining the study, a representative tumor specimen is required for testing specific proteins and biomarkers. This is necessary to determine eligibility for the trial.
Step 2
Initial assessment
An initial assessment is conducted to confirm disease progression and ensure it aligns with the study's criteria. This includes verifying that the disease has progressed during or after one platinum-based treatment for advanced urothelial carcinoma.
Step 3
Treatment stage 1
During Stage 1, treatment involves the administration of tiragolumab, atezolizumab, and gemcitabine hydrochloride. These medications are given through an intravenous (IV) infusion.
The objective is to evaluate the response rate to these immunotherapy-based treatments.
Step 4
Treatment stage 2
Stage 2 continues with the treatment regimen, focusing on patients with measurable disease as per specific criteria. The goal is to assess the complete response to the treatment.
Step 5
Monitoring and evaluation
Throughout the trial, regular monitoring is conducted to assess progression-free survival, overall survival, and the duration of response.
Adverse events and changes in vital signs are closely monitored to ensure safety and adjust treatment as necessary.
Step 6
Completion of trial
The trial is estimated to conclude by May 18, 2027. Final evaluations will be conducted to determine the overall effectiveness and safety of the treatment combinations.

Who can join the trial?

9 criteria

Patients must have a type of cancer called urothelial carcinoma (UC).
For Stage 1, patients need to provide a sample of their tumor that can be tested for certain proteins, like Programmed death-ligand 1 (PD-L1), which helps in understanding the cancer better.
Patients should have experienced their disease getting worse during or after one treatment that includes a drug called platinum, used for advanced UC that cannot be removed by surgery.
Patients must have a disease that can be measured using a specific method called RECIST v1.1, which helps in tracking the size of tumors.
Patients need to have a negative test for HIV at the start of the study.
For those with a type of bladder cancer called Muscle Invasive Bladder Cancer (MIBC), a sample from a procedure called TURBT is needed for testing.
For MIBC patients, the disease should not have spread to lymph nodes or other parts of the body, confirmed by a CT or MRI scan done within 4 weeks before starting the study treatment.
Both men and women can participate in the study.
The study includes people who might be considered vulnerable, meaning they might need extra care or protection.

Who cannot join the trial?

8 criteria

Patients with other types of cancer besides urothelial carcinoma cannot participate. Urothelial carcinoma is a type of cancer that affects the urinary system.
Patients who have received certain treatments for cancer recently may not be eligible.
Individuals with severe or uncontrolled medical conditions that could interfere with the study may be excluded.
Patients who are pregnant or breastfeeding are not allowed to participate.
People who have participated in another clinical trial recently might not be eligible.
Individuals with a history of allergic reactions to similar treatments may be excluded.
Patients with certain infections or diseases that could affect the study results may not be eligible.
Individuals who are unable to follow the study procedures or attend required visits may be excluded.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Athens Medical Center S.A.
Verified
Thessaloniki, Greece
Centre Francois Baclesse
Verified
Caen, France
Hospital Universitario Hm Sanchinarro
Responsive
Madrid, Spain

Trial locations

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Investigated drugs

Atezolizumab
is an immunotherapy medication used in this trial. It works by helping the immune system recognize and attack cancer cells, specifically in patients with urothelial carcinoma. This medication is part of a treatment combination being evaluated for its effectiveness in improving the response rate in patients with metastatic urothelial carcinoma.
Cabozantinib
is another medication involved in the trial. It is a type of targeted therapy that interferes with the growth and spread of cancer cells. In this study, it is used in combination with other treatments to assess its impact on the cancer's progression and the patient's overall response to the therapy.
Ipatasertib
is included in the trial as well. This medication targets specific pathways in cancer cells to inhibit their growth. It is being tested in combination with other therapies to determine its effectiveness in treating urothelial carcinoma.
Sacituzumab Govitecan
is a medication used in this study. It is an antibody-drug conjugate that delivers chemotherapy directly to cancer cells, aiming to reduce side effects and improve treatment outcomes. The trial is evaluating its role in combination with other treatments for urothelial carcinoma.
Rucaparib
is part of the trial's treatment regimen. It is a type of medication known as a PARP inhibitor, which helps prevent cancer cells from repairing themselves, leading to their death. This study is testing its effectiveness when used alongside other therapies for urothelial carcinoma.

What is already known about the treatment

Immunotherapy-Based Treatment – This medication is administered through intravenous infusion, typically in a clinical setting. It is currently being studied in clinical trials for its effectiveness and safety in treating urothelial carcinoma, a type of bladder cancer. The main therapeutic indication is for patients with metastatic urothelial carcinoma, where it aims to improve the objective response rate. At the molecular level, the medication works by enhancing the body's immune response to target and destroy cancer cells. It falls under the pharmacological classification of immunotherapy, which involves using the immune system to fight cancer.

Investigated diseases

Urothelial Carcinoma – Urothelial carcinoma is a type of cancer that typically begins in the urothelial cells lining the bladder. It can also occur in other parts of the urinary tract, such as the ureters and urethra. The disease often starts as a superficial tumor but can progress to invade deeper layers of the bladder wall and potentially spread to other parts of the body. Symptoms may include blood in the urine, frequent urination, and pain during urination. As the disease advances, it may lead to more severe symptoms and complications. The progression of urothelial carcinoma can vary, with some cases remaining localized while others become more aggressive and metastatic.