Not recruitingRare disease

Study on Durvalumab and Rintatolimod 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 a type of cancer known as metastatic pancreatic cancer. This is a condition where cancer that started in the pancreas has spread to other parts of the body. The study is testing a combination of two treatments: durvalumab and rintatolimod. Durvalumab, also known by its code name MEDI4736, is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells. Rintatolimod, also known as Ampligen, is a TLR-3 agonist, which means it helps activate the immune system to fight cancer.

The purpose of this study is to evaluate the safety and effectiveness of combining these two treatments in patients with metastatic pancreatic cancer. The study will begin with a phase to ensure the combination is safe for patients, followed by a phase to assess how well the treatment works. Participants will receive the treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will monitor patients over time to see how the cancer responds to the treatment and to check for any side effects.

Throughout the study, various aspects will be observed, such as overall survival, which is the length of time patients live after starting the treatment, and progression-free survival, which is the time during which the cancer does not get worse. The study will also look at changes in the immune system and the quality of life of the participants. This research aims to provide valuable information on the potential benefits of using durvalumab and rintatolimod together for treating metastatic pancreatic 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 patient will undergo an initial assessment to confirm eligibility. This includes verifying a diagnosis of metastatic pancreatic cancer and ensuring adequate organ function and overall health status.
Step 2
Treatment initiation
The treatment involves a combination of two medications: durvalumab and rintatolimod. Both are administered through an intravenous infusion.
Durvalumab is provided as a 50 mg/mL concentrate for solution for infusion. The specific dosage and frequency will be determined based on the patient's response and tolerance.
Step 3
Phase Ib safety run-in
The initial phase, known as phase Ib, focuses on determining the safety of the combination therapy. This involves monitoring for any adverse effects and adjusting dosages as necessary to avoid dose-limiting toxicity.
This phase lasts for 6 weeks after the first day of the first cycle of durvalumab, with each cycle lasting 28 days.
Step 4
Phase II clinical benefit assessment
In phase II, the primary goal is to assess the clinical benefit of the combination therapy. This is evaluated by measuring the response of the cancer, which can be stable disease, partial response, or complete response, according to specific criteria.
The assessment occurs 6 months after starting the combination therapy.
Step 5
Ongoing monitoring and assessments
Throughout the trial, the patient's overall survival and progression-free survival will be monitored. This involves regular check-ups to track the cancer's progression and the patient's health status.
Quality of life will be assessed at various intervals: baseline, 5 weeks, 13 weeks, 25 weeks, 37 weeks, and 49 weeks after starting the immunotherapy.
Step 6
End of trial
The estimated end date for the trial is March 1, 2026. At the conclusion of the trial, a final assessment will be conducted to evaluate the overall outcomes and benefits of the treatment.

Who can join the trial?

16 criteria

Must have **metastatic pancreatic cancer** confirmed by a specific type of medical test.
Must have **adequate kidney function**, meaning the kidneys are working well enough.
Must have **adequate liver tests**, which means the liver is functioning properly.
Must have **adequate bone marrow function**, which involves having enough white blood cells, platelets, and hemoglobin.
Must use **effective contraceptive methods** to prevent pregnancy during the study.
Must have a **life expectancy of at least 12 weeks**.
Must be **willing and able to follow the study rules**, including attending treatment sessions and check-ups.
Must be able to **give written consent**, agreeing to the study's requirements and restrictions.
Must have **stable disease** after at least 8 cycles of a specific chemotherapy treatment called FOLFIRINOX.
Must join the study **within 6 weeks after stopping FOLFIRINOX** treatment.
Must have a **metastatic lesion** that can be accessed for tissue collection.
Must have a **Systemic Immune-Inflammation Index (SIII) less than 900**.
Must have a **CA 19.9 level less than 1000 kU/L**, which is a specific blood test result.
Must be **18 years or older** at the time of joining the study.
Must have a **body weight over 30 kg**.
Must have a **WHO performance status of 0-1**, indicating a good level of daily functioning.

Who cannot join the trial?

13 criteria

Patients with other types of cancer besides metastatic pancreatic cancer cannot participate. Metastatic means the cancer has spread to other parts of the body.
Patients who have had a different cancer in the past, unless it was treated and has not come back for at least 5 years, are excluded.
Patients with serious heart problems, like heart failure or a recent heart attack, cannot join the study.
Patients with uncontrolled high blood pressure are not allowed to participate.
Patients with active infections, such as HIV or hepatitis, are excluded.
Patients who are pregnant or breastfeeding cannot take part in the trial.
Patients who have had an organ transplant are not eligible.
Patients who are taking certain medications that might interfere with the study treatment are excluded.
Patients with a history of severe allergic reactions to similar drugs are not allowed to participate.
Patients with autoimmune diseases, where the immune system attacks the body, are excluded.
Patients who have participated in another clinical trial within the last 4 weeks cannot join this study.
Patients with a history of drug or alcohol abuse in the past year are not eligible.
Patients who cannot follow the study procedures or attend the required visits are excluded.

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Verified sites

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Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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Rotterdam, The Netherlands

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Investigated drugs

Durvalumab
is a type of medication known as an immune checkpoint inhibitor. It works by helping the immune system recognize and attack cancer cells. In this trial, durvalumab is being used to treat patients with metastatic pancreatic ductal adenocarcinoma, a type of advanced pancreatic cancer. The goal is to see if it can improve the body's ability to fight the cancer when used in combination with another medication.
Rintatolimod
is a medication that acts as an immune system modulator. It is designed to stimulate the immune system to better respond to cancer cells. In this study, rintatolimod is combined with durvalumab to evaluate if the combination can enhance the effectiveness of the treatment for patients with metastatic pancreatic ductal adenocarcinoma. The trial aims to assess the safety and potential benefits of using these two medications together.

What is already known about the treatment

Durvalumab
This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating metastatic pancreatic cancer. It is an immune checkpoint inhibitor that works by blocking the PD-L1 protein, helping the immune system to detect and attack cancer cells more effectively. Durvalumab is classified as a monoclonal antibody and is primarily used in cancer immunotherapy.
Rintatolimod
This medication is administered intravenously and is being evaluated in clinical trials for its potential to treat metastatic pancreatic cancer. It acts as a TLR-3 agonist, which means it stimulates the immune system by activating toll-like receptor 3, enhancing the body's ability to fight cancer. Rintatolimod is classified as an immunomodulatory agent and is used to boost immune responses in various therapeutic areas.

Investigated diseases

Metastatic Pancreatic Cancer – This is a type of cancer that originates in the pancreas and has spread to other parts of the body. The pancreas is an organ that plays a role in digestion and blood sugar regulation. When cancer cells break away from the primary tumor in the pancreas, they can travel through the bloodstream or lymphatic system to form new tumors in other organs. This disease often progresses rapidly, as the cancer cells multiply and invade surrounding tissues. Symptoms may include abdominal pain, weight loss, and jaundice. The progression of the disease can vary, but it typically involves the growth and spread of cancerous cells to distant organs.