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Study on the Safety and Effects of Nivolumab, Ipilimumab, Gemcitabine, and Paclitaxel for Patients with Advanced Pancreatic Cancer

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What is this study about?

This clinical trial is focused on studying the treatment of pancreatic cancer, specifically in cases where the cancer is borderline resectable, locally advanced, or has spread to other parts of the body. The study will explore the safety and potential effectiveness of combining different treatments. The treatments being tested include a combination of immunotherapy drugs, nivolumab and ipilimumab, with standard chemotherapy drugs, gemcitabine hydrochloride and nab-paclitaxel. Immunotherapy is a type of treatment that helps the body’s immune system fight cancer. Chemotherapy uses drugs to kill cancer cells or stop them from growing. The study will also include a phase where patients receive a combination of these treatments followed by radiation therapy, which uses high-energy rays to target and kill cancer cells.

The purpose of this study is to evaluate the safety and side effects of the treatment combination and to see how well it works in treating pancreatic cancer. Participants in the study will receive the treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will be conducted in phases, starting with the combination of immunotherapy and chemotherapy, followed by the addition of radiation therapy. Throughout the study, participants will undergo regular medical imaging tests, such as MRI or CT scans, to monitor the cancer’s response to the treatment. These imaging tests help doctors see inside the body and check how the cancer is reacting to the treatment.

The study aims to provide valuable information about the potential benefits and risks of this treatment approach for pancreatic cancer. By combining different types of therapies, researchers hope to improve the effectiveness of treatment and offer new options for patients with this challenging disease. The study will continue until 2026, with the goal of gathering comprehensive data on the treatment’s impact on patients’ health and quality of life.

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.

Blood tests and imaging studies such as MRI or CT scans are performed to establish a baseline for your condition.

2 treatment phase 1

The first phase of treatment involves receiving a combination of medications through an intravenous infusion. These medications include nivolumab, ipilimumab, gemcitabine hydrochloride, and paclitaxel albumin-bound.

The specific dosage and frequency of these medications are determined by the study protocol and are administered under medical supervision.

3 monitoring and evaluation

Regular monitoring is conducted to assess the body’s response to the treatment. This includes blood tests, imaging studies, and physical examinations.

Any side effects or adverse reactions are documented and managed by the healthcare team.

4 treatment phase 2

Following the initial treatment phase, a second phase involves the continuation of nivolumab in combination with gemcitabine hydrochloride and paclitaxel albumin-bound.

This phase may also include MRI or CT-guided adaptive stereotactic body radiation therapy (SBRT) to target the cancer more precisely.

5 follow-up and conclusion

After completing the treatment phases, follow-up visits are scheduled to monitor long-term effects and overall health.

The study concludes with a final assessment to evaluate the safety and effectiveness of the treatment regimen.

Who Can Join the Study?

  • Must have signed and dated a written consent form to participate in the study, agreeing to follow the study’s requirements.
  • Men who are sexually active with women who can become pregnant must use a reliable birth control method with a failure rate of less than 1% per year. This must continue for 31 weeks after the last dose of the study drug.
  • Women who can become pregnant must use a highly effective birth control method, continuing for 23 weeks after the last dose of the study drug.
  • Must have a confirmed diagnosis of borderline resectable, locally advanced, or metastatic pancreatic cancer through tissue examination.
  • Must not have received any previous chemotherapy treatments for pancreatic cancer.
  • Must be 18 years of age or older.
  • Must have a life expectancy of more than 6 months.
  • Must have an ECOG/WHO Performance Status of 0-1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
  • Must agree to undergo required biopsies (tissue samples) before and during the treatment, if considered safe by the doctor.
  • Must have normal organ and bone marrow function, including:
    • Absolute neutrophil count (ANC) of at least 1.5 x 109/L
    • Platelet count of at least 100 x 109/L
    • Serum bilirubin level of 1.5 times the upper limit of normal or less (patients with Gilbert’s Syndrome must have a total bilirubin of 50 mmol/L or less)
    • Aspartate transaminase (AST)/Alanine transaminase (ALT) levels of 5 times the upper limit of normal or less
    • Serum creatinine level of 1.5 times the upper limit of normal or less, or a creatinine clearance (CrCl) of at least 40 mL/min

Who Cannot Join the Study?

  • Patients with any other type of cancer that is not borderline resectable, locally advanced, or metastatic pancreatic cancer cannot participate. This means if the cancer is not in the pancreas or is in a different stage, the patient is not eligible.
  • 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, such as heart failure or a recent heart attack, cannot join the study.
  • Patients with uncontrolled high blood pressure, which means blood pressure that is not managed well with medication, are not eligible.
  • Patients with active infections, which are infections that are currently causing symptoms and need treatment, cannot participate.
  • Patients who are pregnant or breastfeeding are excluded from the study.
  • Patients with a history of severe allergic reactions to any of the study drugs cannot join.
  • Patients with autoimmune diseases, which are conditions where the immune system attacks the body, are not eligible.
  • Patients who have received another experimental treatment within the last 4 weeks are excluded.
  • Patients with a history of drug or alcohol abuse that could interfere with the study are not eligible.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Herpcp Hmpcsfkv Herlev Denmark

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

Trial status

Country Status Recruitment Start
Denmark Denmark
Not recruiting
18.02.2020

Trial locations

Investigated drugs:

Nivolumab is a type of medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells more effectively. In this trial, it is used to enhance the body’s immune response against pancreatic cancer.

Ipilimumab is another immune checkpoint inhibitor. It helps activate the immune system to fight cancer by targeting a specific protein that usually helps keep the immune system in check. When used with nivolumab, it aims to boost the immune system’s ability to destroy cancer cells.

Gemcitabine is a chemotherapy drug that works by interfering with the DNA of cancer cells, preventing them from growing and dividing. It is commonly used to treat various types of cancer, including pancreatic cancer, and is part of the standard chemotherapy regimen in this trial.

Nab-Paclitaxel is a form of chemotherapy that uses tiny particles to deliver the drug paclitaxel to cancer cells. It helps stop the growth of cancer cells by preventing them from dividing. In this trial, it is used alongside gemcitabine to enhance the treatment’s effectiveness against pancreatic cancer.

Pancreatic Cancer – Pancreatic cancer is a disease where malignant cells form in the tissues of the pancreas. It often begins in the ducts that carry pancreatic juices, but it can also form in hormone-producing cells. The disease progresses as the cancer cells grow uncontrollably, potentially spreading to nearby organs and tissues. As it advances, it can invade blood vessels and lymph nodes, making it more challenging to manage. The progression can lead to symptoms such as jaundice, weight loss, and abdominal pain. Over time, the cancer may metastasize to distant parts of the body, further complicating its course.

Trial ID:
2024-518173-34-00
Protocol code:
GI 1931
NCT ID:
NCT04247165
Trial Phase:
Human Pharmacology (Phase I) – Other

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