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Study on the Effects of Durvalumab and Tazemetostat for Adults with Advanced Solid Tumors

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 combining two treatments, Durvalumab and Tazemetostat, on various types of advanced cancers. The cancers being studied include pancreatic cancer, colorectal cancer that is not MSI-H or MMR-deficient, metastatic solid tumors with certain immune characteristics, and soft-tissue sarcoma. The purpose of the study is to investigate how well these treatments work together in controlling or reducing the size of these cancers.

Participants in the study will receive the treatments over a period of up to 24 weeks. Durvalumab is given as an infusion, which means it is administered directly into the bloodstream through a vein. Tazemetostat is taken orally as a tablet. The study will monitor how the cancer responds to the treatment, looking for signs of disease control or reduction in tumor size. The study will also assess the safety of using these two treatments together.

The trial is divided into different groups, or cohorts, based on the type of cancer. Each group will be evaluated for specific outcomes, such as the rate of disease control or the response rate within the 24-week period. The study aims to provide insights into the effectiveness of combining epigenetic therapy with immune therapy to treat these advanced cancers. Participants will be closely monitored throughout the study to ensure their safety and to gather data on the treatments' effects.

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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.
A blood test is performed to ensure adequate hematological, renal, metabolic, and hepatic functions. A pregnancy test is required for women of childbearing potential.
Step 2
Treatment initiation
The treatment involves two medications: tazemetostat and durvalumab.
Tazemetostat is taken orally. The dosage and frequency are determined by the study protocol.
Durvalumab is administered through an intravenous infusion. The dosage and frequency are specified in the study protocol.
Step 3
Treatment monitoring
Regular monitoring is conducted to assess the response to treatment. This includes imaging tests to measure tumor size and blood tests to monitor health status.
Participants are evaluated for any side effects or adverse reactions to the medications.
Step 4
Response evaluation
The response to treatment is evaluated based on specific criteria. This includes measuring the disease control rate and objective response rate within 24 weeks of treatment onset.
For participants with soft-tissue sarcomas, a 6-month progression-free rate is assessed.
Step 5
Follow-up
After completing the treatment phase, follow-up visits are scheduled to monitor long-term health and any delayed side effects.
Participants are encouraged to report any new symptoms or health changes during this period.

Who can join the trial?

14 criteria

Participants must have **advanced disease**, which means the cancer has spread or cannot be removed by surgery.
Participants must be **18 years or older**.
Participants must have a **confirmed diagnosis** of specific types of cancer, such as pancreatic cancer, colorectal cancer, certain solid tumors, or soft-tissue sarcomas.
Participants must not have had any other cancer diagnosed or treated in the last 2 years, except for certain types that were treated successfully.
Participants must have had at least **three weeks** since their last cancer treatment, like chemotherapy or radiotherapy.
Participants must have recovered from any side effects of previous treatments to a certain level, except for hair loss or mild nerve issues.
Women who can have children must have a **negative pregnancy test** before joining the study and must use effective birth control during and after the study.
Men must also agree to use effective birth control during and after the study.
Participants must **sign a consent form** to show they understand and agree to the study.
Participants must have **social security** as required by French law.
Participants in certain groups must provide a **tumor tissue sample** for specific tests.
Participants must have a **life expectancy** of more than 3 months.
Participants must not have other treatment options that are known to work well for their condition.
Participants must have **adequate blood, kidney, and liver function** as determined by specific medical tests.

Who cannot join the trial?

10 criteria

Participants who have a type of cancer that is not a solid tumor, which means the cancer is not in a solid mass.
Participants who have a solid tumor that can be surgically removed, meaning the tumor can be taken out through an operation.
Participants who are under the age of 18, as the study is for adults only.
Participants who are pregnant or breastfeeding, as the study may affect the baby.
Participants who have a medical condition that makes it unsafe for them to participate, as determined by the study doctors.
Participants who are currently taking other medications that might interfere with the study treatment.
Participants who have had another cancer treatment within a certain time frame before the study starts.
Participants who have an active infection, which means they have a disease caused by germs that is currently affecting their health.
Participants who have a history of severe allergic reactions to the study drugs or similar drugs.
Participants who have a condition that affects their immune system, which is the body's defense against infections and diseases.

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Verified sites

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

Centre Hospitalier Regional Et Universitaire De Brest
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Brest, France
Centre Hospitalier Universitaire De Poitiers
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Poitiers, France

Trial locations

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Investigated drugs

Durvalumab
is a type of medication known as an immune checkpoint inhibitor. It works by helping the body's immune system recognize and attack cancer cells more effectively. In this trial, durvalumab is being used to see if it can help control or reduce the growth of various types of cancer, including pancreatic cancer, colorectal cancer, metastatic solid tumors, and soft-tissue sarcoma.
Tazemetostat
is a medication that targets specific enzymes involved in the regulation of gene expression. By inhibiting these enzymes, tazemetostat can potentially slow down or stop the growth of cancer cells. In this study, it is being used in combination with durvalumab to explore its effectiveness in treating different cancer types, such as pancreatic cancer, colorectal cancer, metastatic solid tumors, and soft-tissue sarcoma.

What is already known about the treatment

Durvalumab
Durvalumab is administered as an intravenous infusion, typically given in a clinical setting under the supervision of healthcare professionals. It is currently being studied in clinical trials for its effectiveness in treating various types of cancer, including pancreatic and colorectal cancer, as well as other solid tumors. The main therapeutic indication for durvalumab is its use as an immune checkpoint inhibitor, which helps the immune system recognize and attack cancer cells. At the molecular level, durvalumab works by blocking the PD-L1 protein on cancer cells, preventing them from evading the immune response. It is classified pharmacologically as a monoclonal antibody used in cancer immunotherapy.
Tazemetostat
Tazemetostat is taken orally in the form of tablets, allowing for convenient administration at home or in a clinical setting. It is being explored in clinical trials for its potential to treat various cancers, including soft-tissue sarcoma and other solid tumors. The primary therapeutic use of tazemetostat is as an epigenetic therapy, targeting specific enzymes involved in cancer cell growth. Its mechanism of action involves inhibiting the EZH2 enzyme, which plays a role in gene expression and tumor progression. Tazemetostat is classified as an epigenetic modifier in cancer treatment.

Investigated diseases

Pancreatic Cancer
This is a type of cancer that begins in the tissues of the pancreas, an organ located behind the lower part of the stomach. It often progresses silently, with symptoms appearing only in advanced stages. As the disease advances, it may cause abdominal pain, weight loss, and jaundice. The cancer can spread to nearby organs and tissues, making it challenging to manage. It is known for its aggressive nature and resistance to many treatments.
Colorectal Cancer
This cancer affects the colon or rectum, parts of the large intestine. It typically starts as small, benign clumps of cells called polyps, which can become cancerous over time. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort. As it progresses, the cancer can invade deeper layers of the colon and spread to other parts of the body. Early detection through screening can help manage its progression.
Metastatic Solid Tumors
These are cancers that have spread from their original site to other parts of the body. They can originate from various organs and are characterized by their ability to invade distant tissues. The progression involves the detachment of cancer cells from the primary tumor, traveling through the bloodstream or lymphatic system. Symptoms depend on the location of metastasis and may include pain, organ dysfunction, and general weakness. The presence of a positive interferon gamma signature or tertiary lymphoid structures can influence the tumor's behavior and response to treatment.
Soft-Tissue Sarcoma
This is a group of cancers that begin in the tissues that connect, support, or surround other structures and organs of the body. These tissues include muscle, fat, blood vessels, nerves, tendons, and the lining of the joints. The disease can develop anywhere in the body but is most common in the arms, legs, and trunk. As it progresses, it may cause a noticeable lump or swelling, pain, or limited movement in the affected area. The cancer can spread to other parts of the body, complicating treatment efforts.