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Study on Maintenance Therapy with OSE2101 and FOLFIRI for Patients with Advanced Pancreatic Cancer After Initial FOLFIRINOX Treatment

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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 called pancreatic ductal adenocarcinoma, which can be locally advanced or has spread to other parts of the body. The study is testing a treatment approach that includes a medication known as OSE2101 (also referred to by its code name, OSE2101) combined with a chemotherapy regimen called FOLFIRI, or using FOLFIRI alone. FOLFIRI is a combination of chemotherapy drugs, including fluorouracil, irinotecan, and levoleucovorin. The purpose of the study is to evaluate the effectiveness of these treatments in maintaining the health of patients who have already undergone initial treatment with another chemotherapy regimen called FOLFIRINOX.

Participants in the study will receive either the combination of OSE2101 and FOLFIRI or FOLFIRI alone. The study will monitor the participants over a period to see how well they respond to the treatment and how long they live without the cancer getting worse. The study will also look at the side effects of the treatments and how they affect the participants' quality of life. Some participants may receive a placebo as part of the study to help compare the effects of the actual treatments.

The trial is designed to help researchers understand if the combination of OSE2101 and FOLFIRI is more effective than FOLFIRI alone in treating this type of cancer. The study will involve regular check-ups and assessments, including imaging tests like CT scans, to track the progress of the disease and the impact of the treatment. The results of this study could provide valuable information for future treatment options for patients with pancreatic ductal adenocarcinoma.

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
Induction therapy
The initial phase involves receiving FOLFIRINOX chemotherapy for 4 months. This includes 8 cycles of treatment, with a CT scan performed at the end of the 8th cycle to assess the response.
FOLFIRINOX is a combination of drugs used to treat pancreatic cancer. It includes levoleucovorin, fluorouracil, and irinotecan hydrochloride trihydrate, administered through infusion.
Step 2
Maintenance therapy
After completing the induction therapy, the maintenance phase begins. This involves either continuing with FOLFIRI alone or combining it with OSE2101.
FOLFIRI consists of fluorouracil and irinotecan hydrochloride trihydrate, administered through infusion. OSE2101 is an emulsion for injection.
Step 3
Treatment administration
The medications are administered as follows: ELVORINE (levoleucovorin) is given as a solution for injection, FLUOROURACILE PFIZER is a solution for infusion, and IRINOTECAN VIATRIS is a concentrate for solution for infusion.
The frequency and dosage of these medications are determined by the healthcare provider based on individual patient needs and response to treatment.
Step 4
Monitoring and assessment
Throughout the trial, regular monitoring through CT scans and other assessments is conducted to evaluate the response to treatment and any potential side effects.
The primary goal is to assess overall survival and progression-free survival, along with monitoring any adverse effects.
Step 5
End of trial
The trial is expected to conclude by December 30, 2024. The final assessments will be conducted to determine the outcomes of the treatment.
Patients will be evaluated for overall survival at 12 months, and any data collected will contribute to understanding the effectiveness of the treatment.

Who can join the trial?

13 criteria

Must sign and date an informed consent document, showing willingness and ability to follow the study requirements.
Have a disease that has come back or is advanced and cannot be treated with surgery to cure it. Previous surgery to remove the main tumor is allowed.
Have tumors that can be measured or seen on a scan, even if they don't meet specific measurement criteria.
Show stable disease or tumor response after 4 months of initial chemotherapy treatment with FOLFIRINOX.
Have a tissue sample from a previous biopsy available or be willing to provide a new biopsy sample.
Have proper organ function, which includes specific levels of liver enzymes, bilirubin, blood proteins, and blood cell counts.
Have a life expectancy of at least 3 months.
Women who can have children must have a negative pregnancy test before starting treatment and agree to use reliable birth control. Men must also agree to use birth control if they are sexually active with women who can have children.
Be registered in a national health care system.
Have a confirmed diagnosis of pancreatic ductal adenocarcinoma (PDAC) through tissue examination.
Be at least 18 years old.
Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1, which means being fully active or having some symptoms but being able to carry out light work.
Have a specific genetic marker called HLA-A2.

Who cannot join the trial?

6 criteria

Patients who have not been diagnosed with locally advanced or metastatic Pancreatic ductal adenocarcinoma cannot participate. This means the cancer must be in the pancreas and either spread to nearby areas or other parts of the body.
Patients who are not HLA-A2 positive cannot participate. HLA-A2 is a specific type of protein on the surface of cells that is important for the immune system.
Patients who have not completed a 4-month induction chemotherapy with FOLFIRINOX without the disease getting worse cannot participate. Induction chemotherapy is the first treatment given to shrink a tumor before the main treatment.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Both male and female patients are eligible, so gender is not a reason for exclusion.
Patients who are considered part of a vulnerable population are not excluded, meaning they can participate if they meet other criteria.

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Verified sites

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

Verified
Besancon University Hospital Center
Besançon, France
Verified
CHU Croix Rousse-Lyon
Lyon, France
Responsive
Institut De Cancerologie De Lorraine
Vandoeuvre Les Nancy, France

Trial locations

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Investigated drugs

OSE2101
is an investigational medication being studied for its potential to help the immune system fight cancer. In this trial, it is used as part of a maintenance therapy to see if it can improve survival in patients with pancreatic cancer who have already received initial chemotherapy.
FOLFIRI
is a combination of chemotherapy drugs used to treat certain types of cancer. It includes a mix of medications that work together to stop cancer cells from growing and dividing. In this trial, FOLFIRI is used as a maintenance therapy to help control pancreatic cancer after initial treatment.
FOLFIRINOX
is a combination of chemotherapy drugs used as an initial treatment for pancreatic cancer. It is designed to shrink tumors and slow the progression of the disease. In this study, patients receive FOLFIRINOX before moving on to maintenance therapy with either OSE2101 plus FOLFIRI or FOLFIRI alone.

What is already known about the treatment

OSE2101 – This medication is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating locally advanced or metastatic pancreatic ductal adenocarcinoma. It is used as a maintenance therapy in combination with FOLFIRI, a chemotherapy regimen, after initial treatment with FOLFIRINOX. OSE2101 works by stimulating the immune system to recognize and attack cancer cells, specifically targeting certain proteins on the surface of these cells. It is classified as an immunotherapy agent, focusing on enhancing the body's natural defenses against cancer.

Investigated diseases

Pancreatic Ductal Adenocarcinoma – This is a type of cancer that begins in the ducts of the pancreas, which is an organ located behind the stomach. It is known for being aggressive and often diagnosed at an advanced stage. The disease can be locally advanced, meaning it has spread to nearby tissues, or metastatic, indicating it has spread to distant parts of the body. As the cancer progresses, it can cause symptoms such as abdominal pain, weight loss, and jaundice. The progression of the disease often involves the invasion of nearby organs and the potential spread to the liver and lungs. Early stages may not present noticeable symptoms, making it challenging to detect until it has advanced.