Not recruiting

Study on the Effectiveness and Safety of Immunotherapy with Atezolizumab, Bevacizumab, and Tiragolumab for Patients with Metastatic Pancreatic Cancer

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 the effects of different treatment combinations for patients with metastatic pancreatic ductal adenocarcinoma, a type of cancer that begins in the pancreas and has spread to other parts of the body. The study aims to evaluate the effectiveness and safety of various immunotherapy-based treatments. Immunotherapy is a type of cancer treatment that helps the immune system fight cancer. The medications being tested include Abraxane (paclitaxel albumin-bound), Gemcitabine, RoActemra (tocilizumab), Avastin (bevacizumab), Atezolizumab, and Tiragolumab. These medications are given as infusions, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to determine how well these treatment combinations work in controlling the cancer and improving patient outcomes. Participants in the study will receive one or more of these medications, and some may receive a placebo. The study will monitor the response of the cancer to the treatment, how long the cancer is controlled, and any side effects experienced by the participants. The study will also look at changes in vital signs, such as heart rate and blood pressure, and other health indicators over time.

Throughout the study, participants will have regular check-ups and tests to assess their health and the progress of the treatment. The study is expected to continue until 2025, allowing researchers to gather comprehensive data on the effectiveness and safety of these treatment combinations for metastatic pancreatic ductal adenocarcinoma.

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, confirmation of a diagnosis of metastatic pancreatic ductal adenocarcinoma (PDAC) is required.
Eligibility is determined based on previous treatments and the availability of a tumor specimen for testing specific markers.
Step 2
Treatment assignment
Participants are assigned to different treatment groups to evaluate the effectiveness of various immunotherapy-based treatment combinations.
Step 3
Treatment administration
The treatment involves the administration of medications through intravenous (IV) infusion.
Medications used include paclitaxel albumin-bound, gemcitabine hydrochloride, tocilizumab, bevacizumab, atezolizumab, and tiragolumab.
The specific dosage and frequency depend on the assigned treatment group.
Step 4
Monitoring and assessments
Regular monitoring of health status is conducted, including assessments of tumor response and side effects.
Tests include imaging studies and laboratory tests to evaluate the effectiveness and safety of the treatment.
Step 5
Follow-up
Participants are followed up to assess progression-free survival and overall survival.
The duration of response and any changes in health status are documented.

Who can join the trial?

8 criteria

The patient must have a confirmed diagnosis of **metastatic pancreatic ductal adenocarcinoma (PDAC)**. This means the cancer has spread from the pancreas to other parts of the body.
For patients in **Cohort 1**, they should not have received any prior systemic treatment for PDAC. Systemic treatment refers to medication that travels through the bloodstream to reach cancer cells all over the body.
For patients in **Cohort 2**, their disease must have worsened while receiving either **5-fluorouracil** or **gemcitabine-based** first-line chemotherapy. First-line chemotherapy is the initial treatment given for cancer. If treated in a locally advanced setting, the cancer must have spread to other parts of the body within 6 months after starting chemotherapy.
A sample of the patient's tumor must be available for testing. This sample will be used to check for **programmed death-ligand 1 (PD-L1)** and other markers. PD-L1 is a protein that can affect the immune system's ability to fight cancer.
The patient must have a **measurable disease**. This means there is at least one tumor that can be measured to see if it changes in size during the study. This is determined using specific criteria called **Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1**.
The patient must have **adequate hematologic and end-organ function test results**. This means their blood and major organs, like the liver and kidneys, are working well enough to participate in the study.
Both **male and female** patients can participate in the study.
The study includes patients from a **vulnerable population**, which means it may include individuals who need special consideration or protection.

Who cannot join the trial?

7 criteria

Patients with other types of cancer besides pancreatic ductal adenocarcinoma (PDAC) cannot participate. PDAC is a specific type of cancer that starts in the pancreas.
Individuals who are not within the specified age range for the study are excluded. The age range is determined by the study organizers.
Participants who are not able to follow the study procedures or who have conditions that might interfere with the study results are not eligible.
People who are pregnant or breastfeeding are not allowed to join the study.
Individuals with certain medical conditions that could affect the study outcomes are excluded. These conditions are determined by the study team.
Patients who have received certain treatments or medications that might interfere with the study are not eligible.
Anyone who is part of a vulnerable population, which means they might need special protection or care, is not allowed to participate.

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Verified sites

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

Hospital General Universitario Gregorio Maranon
Verified
Madrid, Spain
Hospital Universitario De Navarra
Verified
Pamplona, Spain
Hospital Vall d’Hebron
Verified
Barcelona, Spain

Trial locations

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Investigated drugs

Immunotherapy-Based Treatment Combinations are being studied to see how effective they are in treating metastatic pancreatic ductal adenocarcinoma. These treatments work by using the body's immune system to help fight cancer cells. The study is exploring different combinations of these therapies to find the most effective approach for patients with this type of cancer.

What is already known about the treatment

Immunotherapy-Based Treatment Combinations – These treatments are administered intravenously, meaning they are given directly into a vein. They are currently being studied in clinical trials for their effectiveness in treating metastatic pancreatic ductal adenocarcinoma, a type of pancreatic cancer. The main therapeutic goal is to enhance the body's immune response to target and destroy cancer cells. At the molecular level, these treatments work by activating or enhancing the immune system's ability to recognize and attack cancer cells. They are classified under immunotherapy, a type of cancer treatment that uses the body's immune system to fight cancer.

Investigated diseases

Pancreatic ductal adenocarcinoma – This is a type of cancer that begins in the ducts of the pancreas, which is an organ located behind the stomach. It is the most common form of pancreatic cancer and is known for its aggressive nature. The disease often progresses silently, with symptoms appearing only in advanced stages. As it advances, it can cause abdominal pain, weight loss, and jaundice. The cancer cells can spread to nearby organs and tissues, making it challenging to manage. Early detection is difficult, contributing to its complex progression.