Not recruiting

Study of Atezolizumab and Tiragolumab for Patients with Resectable Solid Tumors at Intermediate-High Risk of Recurrence

Verified siteRegistered drugNo placebo

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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 patients with solid tumors, which are a type of cancer that forms in solid organs or tissues. The study is investigating the use of two medications: atezolizumab, also known by its code name RO5541267, and tiragolumab. These medications are given as a solution through a vein, a method known as intravenous infusion. The trial aims to understand how effective these treatments are in preventing the return of cancer after surgery in patients who have a higher risk of their cancer coming back. The study is particularly interested in patients whose tumors have certain characteristics, such as a high number of genetic changes, known as high tumor mutational burden (TMB-H), or a condition called microsatellite instability (MSI-H), which can affect how cancer grows and responds to treatment.

Participants in the study will receive either atezolizumab alone or a combination of atezolizumab and tiragolumab. The study will monitor patients over a period of time to see how well the treatments work in keeping the cancer from returning. This includes checking for any new tumors or other signs of cancer. The study will also look at how long patients live after receiving the treatment and any side effects they might experience. The goal is to gather information that could help improve treatment options for people with solid tumors in the future.

The trial will use a special test called FoundationOne®CDx to analyze the genetic makeup of the tumors. This test helps identify specific genetic changes that might make the cancer more likely to respond to the treatments being studied. By understanding these genetic factors, the study hopes to provide more personalized treatment options for patients with solid tumors. The trial is expected to continue for several years to gather comprehensive data on the effectiveness and safety of the treatments.

The research process

The trial runs in 5 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, the patient must have signed an informed consent form. This confirms understanding and agreement to participate in the trial.
For women of childbearing potential, a negative pregnancy test is required, and effective contraception must be used. Men with female partners of childbearing potential must also use effective contraception.
Step 2
Eligibility confirmation
The patient must be 18 years or older with a performance status that allows normal activity.
The patient must have solid tumors that are resectable and have a high risk of recurrence. Tumors must show high tumor mutational burden (TMB) or microsatellite instability (MSI-H).
The patient must be disease-free after standard therapy and have adequate blood and organ function.
Step 3
Randomization and treatment assignment
The patient will be randomly assigned to receive either atezolizumab alone or in combination with tiragolumab.
Both medications are administered as a solution for infusion through a vein (intravenous use).
Step 4
Treatment administration
The patient will receive atezolizumab (Tecentriq 840 mg) and possibly tiragolumab as part of the treatment regimen.
The frequency and duration of administration will be determined by the study protocol and the patient's response to treatment.
Step 5
Monitoring and follow-up
The patient's health will be monitored regularly to assess the effectiveness of the treatment and any side effects.
The primary goal is to evaluate the disease-free survival rate at 24 months, with additional assessments at 36, 48, and 60 months.
Overall survival and any adverse events will also be tracked.

Who can join the trial?

13 criteria

Must sign an Informed Consent Form, which is a document that explains the study and confirms your agreement to participate.
If you are a female who can have children, you must agree to use a very effective form of birth control to prevent pregnancy during the study.
If you are a male with a female partner who can have children, you must agree to use a very effective form of birth control to prevent pregnancy during the study.
If using oral contraception (birth control pills), it should be combined with another method of birth control because it might interact with the study drugs.
If you are a woman who is not postmenopausal (not having periods anymore) or not surgically sterile, you must have a negative pregnancy test before joining the study. A high level of a hormone called follicle stimulating hormone (FSH) can confirm menopause if you are not using hormonal birth control or therapy.
You must be 18 years of age or older, whether male or female.
You should have an ECOG performance status of 0 to 1, which means you are fully active or have some symptoms but can still carry out light work.
You must have solid tumors that can be surgically removed with the aim of curing the disease, and the tumors should have high TMB (tumor mutational burden) or MSI-H (microsatellite instability-high).
You must have completed standard treatment based on the stage of your disease. If you cannot have additional therapy after surgery, you can still join if you complete a prescreening within 50 days after surgery and enroll in the study within 90 days after surgery.
You must be free of disease after standard therapy to participate in this study.
Your tumor tissue biopsy must show TMB of 13 or more mutations per megabase or MSI-H.
You must be at an intermediate or high risk of the cancer coming back.
You must have adequate blood and organ function, meaning your body is working well enough to participate in the study.

Who cannot join the trial?

12 criteria

Patients who have had another type of cancer in the past, unless it was a type that is not expected to come back.
Patients who have an active infection that needs treatment with antibiotics.
Patients who have a serious heart condition, such as heart failure or a recent heart attack.
Patients who have a condition that affects the immune system, like HIV or lupus.
Patients who are pregnant or breastfeeding.
Patients who have had an organ transplant.
Patients who are taking medications that affect the immune system, like steroids.
Patients who have had a severe allergic reaction to similar medications in the past.
Patients who have a condition that affects the brain or nerves, like multiple sclerosis.
Patients who have a history of drug or alcohol abuse.
Patients who are participating in another clinical trial.
Patients who have a condition that the study doctors believe would make it unsafe for them to participate.

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Verified sites

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

Hospital Universitario 12 De Octubre
Verified
Madrid, Spain
Hospital Vall d’Hebron
Verified
Barcelona, Spain
Virgen del Rocío University Hospital
Verified
Sevilla, Spain

Trial locations

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Investigated drugs

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. This medication is being tested to see if it can help prevent the return of cancer after surgery in patients with certain types of solid tumors.
Tiragolumab
is another medication being studied in this trial. It is used in combination with atezolizumab to enhance the immune system's ability to fight cancer. Tiragolumab works by targeting a different protein that can also inhibit the immune response against cancer cells. The combination of tiragolumab and atezolizumab is being evaluated to determine if it is more effective than atezolizumab alone in preventing cancer recurrence in patients with specific genetic markers in their tumors.

What is already known about the treatment

Atezolizumab
Atezolizumab is administered as an intravenous infusion, typically given in a clinical setting. It is currently being studied in clinical trials for its effectiveness in treating solid tumors, particularly those with a high risk of recurrence. The medication works by blocking a protein called PD-L1, which helps cancer cells evade the immune system. By inhibiting this protein, atezolizumab allows the immune system to better recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor.
Tiragolumab
Tiragolumab is also administered via intravenous infusion and is being evaluated in combination with atezolizumab for the treatment of solid tumors. This medication is in the clinical trial phase and is being studied for its potential to enhance the immune response against cancer. Tiragolumab targets the TIGIT protein, which can suppress immune activity, thereby boosting the body's ability to fight cancer cells. It is classified as an immune checkpoint inhibitor.

Investigated diseases

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, muscles, and bones. These tumors are characterized by the uncontrolled growth of cells that form a solid mass. As they progress, they may invade nearby tissues and organs, potentially causing damage. 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 metastasize. The progression of solid tumors depends on their type, location, and other biological factors.