#1 Clinical Trials Search in Europe

Study on the Safety and Effectiveness of IMM-101 with Radiotherapy for Patients with Limited Metastatic Pancreatic Cancer

1 1 1

What is this study about?

This clinical trial is focused on studying a type of cancer known as metastatic pancreatic cancer, which is when cancer from the pancreas spreads to other parts of the body, like the liver or lungs. The study is testing a treatment that combines a special kind of immunotherapy called IMM-101 with a precise form of radiation therapy known as stereotactic body radiotherapy (SBRT). IMM-101 is a suspension for injection that contains heat-killed bacteria, which is intended to help stimulate the immune system to fight cancer.

The purpose of the study is to evaluate the safety and effectiveness of this combined treatment. Initially, a small group of patients will receive the treatment to ensure it is safe. If the treatment is found to be safe, more patients will be included to further assess how well it works in controlling the cancer. The study aims to see if this combination can improve the time patients live without the cancer getting worse.

Participants in the study will receive the IMM-101 injections along with SBRT. The study will monitor the patients’ overall health, the progression of their cancer, and their quality of life throughout the treatment. The goal is to determine if this new approach can offer better outcomes for patients with limited metastatic pancreatic cancer.

1 Joining the study

Upon joining the study, participation is confirmed through written informed consent.

Eligibility is based on specific criteria, including age, health status, and previous treatments.

2 Safety run-in phase

The initial phase focuses on assessing the safety of combining IMM-101 with stereotactic body radiotherapy (SBRT).

This phase involves 20 patients with limited metastatic pancreatic cancer affecting the liver and/or lungs.

3 IMM-101 administration

IMM-101 is a suspension for intradermal injection, containing heat-killed mycobacterium obuense.

The administration route is intradermal, meaning the injection is given into the skin.

4 Stereotactic body radiotherapy (SBRT)

SBRT is a form of radiotherapy that precisely targets cancer cells in the body.

It is combined with IMM-101 to evaluate the safety and potential benefits of this treatment approach.

5 Second phase of the study

If the combination of IMM-101 and SBRT is deemed safe, the study progresses to the second phase.

This phase includes an additional 80 patients to assess the effectiveness of the treatment.

6 Monitoring and evaluation

Throughout the study, various health parameters are monitored, including immune cell activity and tumor markers.

The study aims to measure progression-free survival, overall survival, and quality of life.

7 Study completion

The study is expected to conclude by May 2029.

Final assessments will determine the safety and efficacy of the treatment combination.

Who Can Join the Study?

  • You must have a confirmed diagnosis of metastatic pancreatic cancer. This means the cancer has spread from the pancreas to other parts of the body.
  • Your liver tests should be within certain limits: bilirubin less than 1.5 times the normal level, and ALAT/ASAT less than 5 times the normal level. These are tests that check how well your liver is working.
  • Your bone marrow function should be adequate. This means your white blood cells should be more than 3.0 x 109/L, platelets more than 100 x 109/L, and hemoglobin more than 5.6 mmol/L. These are measures of your blood health.
  • You must use effective contraceptive methods to prevent pregnancy during the study.
  • You need to provide written informed consent, which means you agree to participate after understanding the study details.
  • If you couldn’t complete at least 8 cycles of a chemotherapy treatment called FOLFIRINOX due to severe side effects, you can still be included in a special group of the study.
  • You should have 5 or fewer metastases (cancer spread) in the liver and/or lungs.
  • The combined size of all liver metastases and the main tumor or any local recurrence in the pancreas should be less than 9 cm.
  • The combined size of all lung metastases should be less than 9 cm.
  • Your CA 19-9 level, a marker used to monitor pancreatic cancer, should be less than 1000 IU/mL after finishing chemotherapy.
  • You should be between 18 and 75 years old.
  • Your WHO performance status should be between 0 and 2. This is a scale that measures your ability to perform daily activities.
  • The size of your primary tumor should be less than 7 cm in each dimension (length, width, height).
  • Your renal function should be adequate, with an eGFR (a test for kidney function) of at least 30 ml/min.

Who Cannot Join the Study?

  • Patients with other types of cancer besides limited metastatic pancreatic cancer cannot participate.
  • Patients who have had previous treatments that might interfere with the study cannot participate.
  • Patients with severe health conditions that could make participation unsafe cannot participate.
  • Patients who are unable to follow the study procedures cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are not willing to use effective birth control methods during the study cannot participate.
  • Patients with allergies to the study medications cannot participate.
  • Patients who have participated in another clinical trial recently cannot participate.
  • Patients with infections that are not well controlled cannot participate.
  • Patients with a history of certain heart conditions cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Eptfnmy Ulxaqwjikmpp Myiexnl Cyphptu Rwdqhogmp (igwzcct Mor Rotterdam The Netherlands

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

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not recruiting
01.01.2021

Trial locations

IMM-101 is an investigational treatment used in this clinical trial. It is being studied for its potential to help the immune system fight cancer. In this trial, it is combined with another therapy to see if it can improve outcomes for patients with limited metastatic pancreatic cancer.

Stereotactic Body Radiotherapy (SBRT) is a type of radiation therapy that precisely targets cancer cells in the body. It delivers high doses of radiation to the tumor while minimizing damage to surrounding healthy tissue. In this trial, SBRT is used in combination with IMM-101 to evaluate if the combination is safe and effective for treating patients with limited metastatic pancreatic cancer.

Limited Metastatic Pancreatic Cancer – This condition occurs when pancreatic cancer cells spread to a limited number of other organs, such as the liver or lungs. The disease begins in the pancreas, an organ that aids in digestion and blood sugar regulation. As the cancer progresses, it can invade nearby tissues and spread to distant parts of the body through the bloodstream or lymphatic system. The spread is considered “limited” when it affects only a few sites outside the pancreas. Symptoms may include abdominal pain, weight loss, and jaundice, depending on the organs involved. The progression of the disease can vary, with some patients experiencing slow growth and others facing more rapid advancement.

Trial ID:
2024-514598-23-00
Trial Phase:
Human Pharmacology (Phase I) – Other

Other Trials to Consider

  • A Study of BMS-986504 Combined with Nab-Paclitaxel and Gemcitabine for Patients with Untreated Metastatic Pancreatic Cancer with MTAP Gene Deletion

    Recruiting

    4 1 1
    Investigated drugs:
    Austria Belgium Czechia Denmark France Germany +9

  • A Study of Ponsegromab Combined with Chemotherapy for Adults with Pancreatic Cancer that has Spread and Caused Weight Loss

    Recruiting

    4 1 1
    Investigated drugs:
    Belgium Bulgaria France Germany Italy Poland +2