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Study on Atezolizumab and Resiquimod Sulfate with Radiotherapy for Patients with Advanced Solid Tumors

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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 the effects of a combination treatment for patients with advanced solid tumors. The diseases being studied include several types of cancer: pancreatic cancer, virus-associated tumors (such as those related to human papillomavirus and Epstein-Barr virus), non-small cell lung cancer, soft-tissue sarcomas, bladder cancer, and triple negative breast cancer. The treatment involves a combination of three components: atezolizumab (also known by its code name RO5541267), EIK1001 (also known as BDB001), and a type of radiation therapy called immunogenic radiotherapy.

The purpose of the study is to evaluate how well this combination treatment works in controlling the growth of these cancers. Participants will receive the treatment over a period of up to 24 weeks. The study will look at how the treatment affects the cancer, including whether it helps to stop the cancer from growing or spreading. The study will also monitor the safety of the treatment and any side effects that may occur.

Participants in the study will be divided into six groups based on their type of cancer. Each group will be observed to see how the treatment affects their specific cancer type. The study aims to provide valuable information on the effectiveness of this combination treatment for different types of advanced solid tumors. The results will help in understanding whether this treatment can be a beneficial option for patients with these types 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, the participant will be informed about the trial's objectives and procedures. Consent will be obtained to ensure understanding and agreement to participate.
Step 2
Initial assessment
An initial assessment will be conducted to confirm eligibility. This includes a review of medical history, current health status, and any previous treatments received.
Step 3
Treatment initiation
The treatment involves a combination of atezolizumab and EIK1001 (also known as BDB001), administered through intravenous infusion. Atezolizumab is provided as Tecentriq 1,200 mg concentrate for solution for infusion, and EIK1001 is a solution for injection at 1.0 mg/mL.
The treatment will also include immunogenic radiotherapy targeting one or more metastatic sites. The specific schedule and dosage will be determined based on individual health conditions and the type of cancer being treated.
Step 4
Ongoing monitoring
Throughout the trial, regular monitoring will be conducted to assess the response to treatment. This includes imaging tests and other evaluations to measure tumor size and progression.
Participants will be monitored for any side effects or adverse reactions to the treatment. Adjustments to the treatment plan may be made based on these observations.
Step 5
Evaluation of treatment response
The primary goal is to evaluate the antitumor activity of the treatment combination. This will be assessed by measuring the disease control rate within 24 weeks for most cancer types, and a 6-month progression-free status for soft-tissue sarcomas.
Secondary evaluations include overall response rate, progression-free survival, and overall survival. These metrics help determine the effectiveness of the treatment over time.
Step 6
Completion of trial
Upon completion of the trial, a final assessment will be conducted to evaluate the overall outcomes and any long-term effects of the treatment.
Participants will receive information on follow-up care and any additional treatments that may be recommended based on the trial results.

Who can join the trial?

16 criteria

Participants must have **metastatic disease**, which means the cancer has spread to other parts of the body.
Participants must be **18 years or older**.
Participants must have a **performance status** of 0 or 1 on the ECOG scale, which measures how well they can perform daily activities.
Participants must have at least two lesions: one that can be treated with **radiotherapy** and another that is measurable and not previously treated with radiotherapy.
Participants must have a **life expectancy** of more than 6 months.
Participants must have at least one tumor site that can be **biopsied** for research purposes.
Participants must provide **archived tumor tissue** for research purposes.
Participants must have **advanced disease** and not be eligible for other approved treatments that could provide significant benefit.
Participants must have **adequate blood, kidney, liver, and metabolic functions** as determined by specific medical tests.
Participants must not have any other **malignant disease** that requires active treatment.
Participants must have waited at least three weeks since their last **chemotherapy, immunotherapy, or radiotherapy**.
Participants must have recovered from any side effects of previous treatments to a mild level, except for hair loss and mild nerve pain.
Women of childbearing potential must have a **negative pregnancy test** before joining the study and before receiving the first dose of study medication.
Both women and men must agree to use an **effective method of contraception** during the study and for five months after stopping treatment.
Participants must provide **written informed consent** before any study procedures.
Participants must have **social security** in compliance with French law.

Who cannot join the trial?

4 criteria

Participants who have not been diagnosed with **metastatic** (advanced) **solid tumors**. **Metastatic** means the cancer has spread to other parts of the body, and **solid tumors** are abnormal masses of tissue that usually do not contain liquid areas.
Participants who do not fall into one of the specific cancer groups being studied, such as pancreatic cancer, virus-associated tumors, certain types of lung cancer, soft-tissue sarcomas, bladder cancer, or triple negative breast cancer.
Participants who are not adults. The study is only for adult participants.
Participants who are part of a vulnerable population, which means groups of people who might be at a higher risk of harm or exploitation.

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Verified sites

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

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Centr Georges Francois Leclerc
Dijon, France
Verified
Centre De Lutte Contre Le Cancer Eugene Marquis
Rennes, France
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Centre Francois Baclesse
Caen, France

Trial locations

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Investigated drugs

Atezolizumab
is a medication used in this trial to help the immune system attack cancer cells. It works by blocking a protein that prevents the immune system from effectively fighting cancer. This medication is being tested in combination with other treatments to see if it can improve outcomes for patients with advanced solid tumors.
EIK1001 (BDB001)
is an experimental drug in this trial that acts as a Toll-like receptor agonist. It is designed to stimulate the immune system to recognize and attack cancer cells more effectively. This medication is being tested alongside atezolizumab and radiotherapy to evaluate its potential benefits in treating various types of advanced cancers.
Immunogenic Radiotherapy
is a type of radiation treatment used in this trial to target and destroy cancer cells. The goal of this therapy is to not only kill cancer cells directly but also to make them more recognizable to the immune system, enhancing the effects of the other treatments being tested in the study.

What is already known about the treatment

Atezolizumab
Atezolizumab is administered intravenously and is currently used in clinical trials for treating advanced solid tumors. It is an approved medication in the medical literature, primarily used for certain types of cancer. The main therapeutic indications include various cancers such as non-small cell lung cancer and bladder cancer. At the molecular level, atezolizumab works by blocking the PD-L1 protein, which helps the immune system detect and attack cancer cells. It is classified as an immune checkpoint inhibitor.
EIK1001 (BDB001)
EIK1001, also known as BDB001, is administered through injection and is being studied in clinical trials for its potential to treat advanced solid tumors. It is not yet widely used in standard medical practice but is gaining attention in medical research. The main therapeutic indication is its use in combination with other treatments for various cancers. Its mechanism of action involves activating Toll-like receptors 7 and 8, which stimulate the immune system to target cancer cells. It is classified as an immunotherapy agent.

Investigated diseases

Pancreatic Cancer
Pancreatic cancer is a disease where malignant cells form in the tissues of the pancreas, an organ located behind the stomach. It often progresses silently, with symptoms appearing only in advanced stages. As the cancer grows, it can spread to nearby organs and lymph nodes. The disease can cause symptoms like jaundice, weight loss, and abdominal pain. It is known for its aggressive nature and difficulty in early detection.
Virus-Associated Tumors
These tumors are linked to infections by certain viruses, such as human papillomavirus (HPV) or Epstein-Barr virus (EBV). The viruses can cause changes in the cells, leading to uncontrolled growth and tumor formation. These tumors can occur in various parts of the body, depending on the virus involved. They may progress slowly or rapidly, depending on the type and location. Symptoms vary widely based on the tumor's location and size.
Non-Small Cell Lung Cancer
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85% of cases. It typically grows and spreads more slowly than small cell lung cancer. NSCLC can cause symptoms like a persistent cough, chest pain, and shortness of breath. As it progresses, it may spread to other parts of the body, including the bones and brain. The disease is often diagnosed at an advanced stage due to subtle early symptoms.
Soft-Tissue Sarcomas
Soft-tissue sarcomas are a group of cancers that begin in the tissues that connect, support, or surround other structures and organs of the body. These can include muscles, fat, blood vessels, nerves, tendons, and the lining of the joints. They can occur anywhere in the body but are most common in the arms, legs, and trunk. The tumors may grow slowly or quickly, and symptoms depend on the tumor's size and location.
Bladder Cancer
Bladder cancer begins in the cells of the bladder, the organ that stores urine. It often starts in the urothelial cells that line the inside of the bladder. The disease can cause symptoms such as blood in the urine, frequent urination, and pain during urination. As it progresses, it may invade deeper layers of the bladder wall and spread to nearby lymph nodes and organs. The progression can vary, with some tumors growing slowly and others more aggressively.
Triple Negative Breast Cancer
Triple negative breast cancer is a type of breast cancer that does not have the three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and the HER-2/neu gene. It tends to be more aggressive and has fewer treatment options compared to other breast cancer types. The cancer can spread quickly to other parts of the body, including the lymph nodes and organs. Symptoms may include a lump in the breast, changes in breast shape, and skin dimpling.