Study on Dostarlimab, Vitamin D3, and Drug Combination for Untreated Metastatic Pancreatic Cancer Patients

2 1 1 1

What is this study about?

This clinical trial is focused on studying metastatic pancreatic cancer, which is a type of cancer that has spread from the pancreas to other parts of the body. The study is testing a combination of treatments to see how effective they are in treating this disease. The treatments being tested include Dostarlimab, an immunotherapy drug that helps the immune system fight cancer cells, and Vitamin D3, which is being used in high doses. These are combined with a chemotherapy regimen known as mFOLFIRINOX, which includes several drugs: Folinic Acid (also known as leucovorin), 5-Fluorouracil (5FU), Irinotecan, and Oxaliplatin. These drugs work together to stop the growth of cancer cells.

The purpose of the study is to evaluate the effectiveness and safety of this combination of treatments in patients who have not received prior treatment for their metastatic pancreatic cancer. Participants in the study will receive these treatments over a period of time, and their response to the treatment will be closely monitored. The study aims to understand how well the cancer responds to the treatment and to assess any side effects that may occur.

Throughout the study, participants will receive regular infusions of the medications, and their health will be monitored by healthcare professionals. The study will help determine if this combination of treatments can improve outcomes for patients with metastatic pancreatic cancer. The results of this study could provide valuable information for future treatment options for this challenging disease.

1 initiation of treatment

Upon joining the study, the treatment begins with the administration of dostarlimab. This medication is given as a 500 mg solution for infusion. The infusion is administered intravenously, which means it is delivered directly into the bloodstream through a vein.

The treatment also includes oxaliplatin, provided as a 5 mg/ml concentrate for infusion. This is also administered intravenously.

2 oral medication

In addition to the infusions, colecalciferol (Vitamin D3) is taken orally. This is provided as a 10,000 UI/ml solution in the form of drops.

3 combination therapy

The treatment regimen includes irinotecan hydrochloride trihydrate, which is a 20 mg/ml solution for infusion. This is administered intravenously.

Additionally, folinic acid is given as a 10 mg/ml solution for injection or infusion, also administered intravenously.

4 chemotherapy

The treatment plan includes fluorouracil, provided as a 50 mg/ml concentrate for infusion. This is administered intravenously.

5 monitoring and evaluation

Throughout the trial, the response to the treatment is monitored. The primary goal is to assess the Objective Response Rate (ORR), which measures the proportion of patients with a reduction in tumor size.

Safety and tolerability of the treatment are evaluated according to established criteria for adverse events.

Who Can Join the Study?

Must have a confirmed diagnosis of Stage IV adenocarcinoma of the pancreas, which means the cancer has spread to other parts of the body.
If there is a history of hepatitis C (HCV) infection, the viral load must be undetectable at the time of screening.
No active infection or serious infection in the past 30 days.
Must be able to understand and willing to sign a consent form before any study procedures.
Must be affiliated with a social security system.
No previous treatment for Stage IV pancreatic adenocarcinoma is allowed.
Must have an ECOG performance status of 0 to 1, which indicates the ability to carry out daily activities.
Age must be between 18 and 75 years.
Must have a measurable disease as per specific guidelines used to evaluate tumors.
Must have accessible tumor tissue available for a fresh biopsy.
Expected to live for more than 3 months.
Men and women who can have children must agree to use effective birth control methods. Women must not be pregnant or breastfeeding and must have a negative pregnancy test before starting the study. Men must use a condom with spermicide and avoid donating sperm during the study and for 120 days after the last dose of the study drug.
Must have certain laboratory values within specific limits, including:
- Platelet count of at least 100,000 cells/mm³
- Absolute neutrophil count (ANC) of at least 1,500 cells/mm³
- Hemoglobin level of at least 9 g/dL
- Liver function tests within specific limits
- Kidney function with a creatinine clearance of at least 50 mL/min
- For those not on warfarin, certain blood clotting tests must be within limits. Those on warfarin can participate if their dose is stable and within therapeutic range.
- Uracilemia level must be less than 16 ng/ml

Who Cannot Join the Study?

Patients who have already received treatment for their pancreatic cancer cannot participate.
Patients with other serious health conditions that might interfere with the study treatment are not eligible.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients with a history of allergic reactions to similar drugs used in the study are excluded.
Patients who are unable to follow the study procedures or attend the required visits are not eligible.
Patients with certain infections, like HIV or hepatitis, are not allowed to participate.
Patients with a history of another type of cancer within the last 5 years, except for some skin cancers, are excluded.
Patients who have had a major surgery within the last 4 weeks cannot join the study.
Patients who are currently participating in another clinical trial are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France

Other Sites

Site Name	City	Country
Hopital Saint Antoine	Paris	France
Hospital Foch	Suresnes	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hopital Beaujon	Clichy	France
Bjghikkz Uhvwwiiglj Hktvxiit Cvxwhw	Besançon	France
Iblpwozj Punqfjhuhxfiwyc Cecruy Coqtua	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	02.09.2024

Trial locations

Investigated drugs:

Dostarlimab is a medication used in this trial to help the immune system recognize and attack cancer cells. It is a type of immunotherapy that targets specific proteins on cancer cells, potentially slowing down or stopping their growth.

Vitamin D3 is included in the trial to support overall health and potentially enhance the effectiveness of cancer treatment. It is a vitamin that helps maintain bone health and may have additional benefits in cancer therapy.

Folinic Acid is used in combination with other chemotherapy drugs to enhance their effectiveness. It helps protect healthy cells and boosts the cancer-fighting effects of the treatment.

5-Fluorouracil (5FU) is a chemotherapy drug that works by interfering with the DNA and RNA of cancer cells, preventing them from growing and dividing. It is a common treatment for various types of cancer.

Irinotecan is another chemotherapy drug used in this trial. It works by inhibiting an enzyme needed for cancer cell division, thereby slowing or stopping the growth of cancer cells.

Oxaliplatin is a chemotherapy medication that damages the DNA of cancer cells, leading to cell death. It is often used in combination with other drugs to treat different types of cancer.

Investigated diseases:

Metastatic Pancreatic Cancer – This is a type of cancer that begins in the pancreas and spreads to other parts of the body. The pancreas is an organ located behind the stomach that plays a role in digestion and blood sugar regulation. In metastatic pancreatic cancer, cancer cells break away from the original tumor and travel through the bloodstream or lymphatic system to form new tumors in other organs. This disease often progresses rapidly, with symptoms that may include abdominal pain, weight loss, and jaundice. As the cancer spreads, it can affect the function of the organs it invades, leading to a variety of complications. The progression of the disease can vary depending on the location and extent of the metastasis.

Trial ID:

2023-510004-49-00

Protocol code:

2023_0111

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Dostarlimab, Vitamin D3, and Drug Combination for Untreated Metastatic Pancreatic Cancer Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?