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Study of Tumor Treating Fields with Atezolizumab, Gemcitabine, and Nab-Paclitaxel for Patients with Metastatic Pancreatic Cancer

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What is this study about?

This clinical trial is focused on studying a type of cancer called metastatic pancreatic ductal adenocarcinoma, which is a form of pancreatic cancer that has spread to other parts of the body. The study is testing a combination of treatments to see how well they work together as a first-line treatment, meaning it’s the first treatment given for this cancer. The treatments being studied include Tumor Treating Fields (TTFields), which is a method that uses electric fields to disrupt cancer cell growth, and three medications: atezolizumab (also known by its code name RO5541267), gemcitabine, and nab-paclitaxel. Atezolizumab is a type of medication called a monoclonal antibody, which helps the immune system fight cancer cells.

The purpose of the study is to evaluate how well these treatments control the disease. Participants will receive the treatments and be monitored to see if the cancer remains stable, shrinks, or disappears. The study will also look at how long participants live after starting the treatment. The study will last for a period of time, and participants will receive the treatments through an intravenous infusion, which means the medication is given directly into a vein.

Throughout the study, participants will have regular check-ups and tests to monitor their health and the effects of the treatment. The goal is to gather information on how effective the combination of TTFields, atezolizumab, gemcitabine, and nab-paclitaxel is in treating metastatic pancreatic ductal adenocarcinoma. This information could help improve treatment options for this type of cancer in the future.

1 beginning of treatment

Upon joining the study, the treatment begins with the administration of atezolizumab, gemcitabine, and nab-paclitaxel. These medications are given to treat metastatic pancreatic ductal adenocarcinoma.

The medication atezolizumab is provided as a solution for infusion, which means it is delivered directly into the bloodstream through a vein. The dosage is 840 mg, and it is administered according to the study schedule.

2 tumor treating fields (TTFields) therapy

In addition to the medications, tumor treating fields (TTFields) therapy is used. This involves the application of electric fields to the tumor area to disrupt cancer cell division.

The TTFields therapy is used in conjunction with the medications to enhance the treatment’s effectiveness.

3 ongoing treatment and monitoring

Throughout the study, regular monitoring is conducted to assess the treatment’s impact on the disease. This includes medical examinations and imaging tests to evaluate the tumor’s response.

The primary goal is to achieve disease control, which means the disease does not progress for at least 16 weeks, or there is a partial or complete response to the treatment.

4 end of treatment

The study aims to continue treatment and monitoring until the estimated end date in August 2026, or until the treatment is no longer beneficial.

The overall survival of participants is also measured, which is the time from the start of treatment until death from any cause.

Who Can Join the Study?

  • Must have signed the Informed Consent Form for the study.
  • Must be 18 years of age or older at the time of signing the Informed Consent Form.
  • Must have an ECOG performance status of 0-1. This is a scale used to assess how a patient’s disease is progressing, including their level of functioning and ability to care for themselves.
  • Must have a confirmed diagnosis of metastatic pancreatic ductal adenocarcinoma through specific medical tests.
  • Must not have received any prior treatment for pancreatic cancer.
  • Must have a life expectancy of at least 3 months.
  • Must have measurable disease in the abdomen, as defined by specific medical criteria (RECIST v1.1).
  • Preferably, the tumor should be accessible for tissue collection. While providing blood and tumor tissue for exploratory study is encouraged, it is not mandatory for participation.
  • Must be able and assigned by the investigator to receive therapy with gemcitabine and nab-paclitaxel, which are types of chemotherapy drugs.
  • Must have adequate blood and organ function, as shown by specific laboratory test results taken within 14 days before starting the study treatment. This includes:
    • Enough white blood cells, red blood cells, and platelets.
    • Normal levels of liver enzymes and bilirubin, with some exceptions for patients with liver or bone metastases.
    • Normal kidney function.
    • Normal blood clotting function, unless receiving stable anticoagulation therapy.
  • If receiving anticoagulation therapy, the regimen must be stable.
  • Must test negative for hepatitis B surface antigen (HBsAg) at screening.
  • Must have a positive hepatitis B surface antibody (HBsAb) test at screening, or meet specific criteria if HBsAb is negative.
  • Must test negative for hepatitis C virus (HCV) antibody at screening, or meet specific criteria if the HCV antibody test is positive.

Who Cannot Join the Study?

  • Patients with other types of cancer that have spread (metastasized) to other parts of the body.
  • Patients who have had another cancer within the last 5 years, except for skin cancer that is not melanoma or in situ cervical cancer.
  • Patients with serious heart problems, such as heart failure or a recent heart attack.
  • Patients with uncontrolled high blood pressure.
  • Patients with active infections that require treatment with antibiotics.
  • Patients with known allergies to the study drugs: atezolizumab, gemcitabine, or nab-paclitaxel.
  • Patients who are pregnant or breastfeeding.
  • Patients with autoimmune diseases, which are conditions where the immune system attacks the body, like lupus or rheumatoid arthritis.
  • Patients who have had an organ transplant.
  • Patients with a history of brain or spinal cord diseases, such as seizures or stroke.
  • Patients who are currently participating in another clinical trial.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Hm Sanchinarro Madrid Spain
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Asklepios Kliniken Hamburg GmbH Hamburg Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Fakultni Nemocnice Bulovka Prague Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
University Hospital Olomouc Olomouc Czechia
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Ffxbarkg nsiwbnsir Mvlkh a Htmhndd Prague Czechia
Hpqojltf Vata dekgukgt Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
21.08.2023
Germany Germany
Not recruiting
21.08.2023
Spain Spain
Not recruiting
21.08.2023

Trial locations

Investigated drugs:

Tumor Treating Fields (TTFields) is a therapy that uses electric fields to disrupt the growth of cancer cells. In this trial, it is used as a treatment for metastatic pancreatic ductal adenocarcinoma. The electric fields are applied to the tumor area using a special device, and the goal is to slow down or stop the cancer cells from dividing and growing.

Atezolizumab is a type of immunotherapy. It works by helping your immune system recognize and attack cancer cells. Atezolizumab is used in this trial to help the body’s natural defenses fight the pancreatic cancer more effectively.

Gemcitabine is a chemotherapy drug that is used to kill cancer cells. It works by interfering with the DNA of the cancer cells, preventing them from growing and dividing. In this trial, gemcitabine is used to help reduce the size of the tumor and control the spread of cancer.

Nab-Paclitaxel is another chemotherapy medication. It is designed to stop cancer cells from dividing and growing by disrupting their internal structures. Nab-paclitaxel is used in this trial to work alongside other treatments to help control the cancer.

Metastatic pancreatic ductal adenocarcinoma – This is a type of cancer that begins in the ducts of the pancreas and has spread to other parts of the body. It typically starts in the cells lining the pancreatic ducts, which are responsible for transporting digestive enzymes. As the disease progresses, cancer cells invade nearby tissues and organs, often spreading to the liver, lungs, or peritoneum. The progression involves the growth of tumors that can obstruct the bile duct, leading to jaundice, or block the stomach, causing digestive issues. Symptoms may include abdominal pain, weight loss, and changes in stool. The disease is known for its aggressive nature and rapid spread to distant organs.

Trial ID:
2024-515407-19-00
Protocol code:
EF-39
NCT ID:
NCT06390059
Trial Phase:
Therapeutic confirmatory (Phase III)

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