Study on the Safety and Effectiveness of Nivolumab and Ipilimumab for Patients with Metastatic Colorectal Cancer with dMMR or MSI

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What is this study about?

This clinical trial is focused on studying a type of cancer called metastatic colorectal cancer, which is a form of cancer that starts in the colon or rectum and spreads to other parts of the body. Specifically, the study is looking at patients with certain genetic features known as dMMR (deficient mismatch repair) and MSI (microsatellite instability). These features can affect how cancer grows and responds to treatment.

The trial is testing two medications, nivolumab and ipilimumab, which are given together as a combination treatment. Nivolumab, also known by its code name BMS936558, and ipilimumab, also known as BMS734016, are both types of drugs called immunotherapies. They work by helping the body’s immune system recognize and attack cancer cells more effectively. The purpose of the study is to evaluate the safety and effectiveness of these two combination treatments over a period of 24 weeks.

Participants in the study will receive the medications through an infusion, which means the drugs are given directly into the bloodstream through a vein. The study will monitor how well the treatments work and any side effects that may occur. The goal is to understand how these treatments can help manage metastatic colorectal cancer with dMMR and MSI features, providing valuable information for future cancer care.

1 initial treatment phase

The treatment involves two medications: nivolumab and ipilimumab. Both are administered as a solution for infusion.

Nivolumab is provided as a 10 mg/mL concentrate, and ipilimumab as a 5 mg/mL concentrate. These are given through an infusion, which is a method of delivering medication directly into the bloodstream over a set period.

The primary goal during the first 24 weeks is to monitor the safety of the treatment and assess the progression of the disease.

2 monitoring and assessment

Throughout the trial, regular assessments are conducted to monitor the safety and effectiveness of the treatment.

The main focus is on identifying any significant side effects and evaluating the progression-free survival (PFS) at week 24.

Additional assessments include the overall response rate (ORR) and overall survival (OS) at various intervals, such as weeks 24, 48, and at 2 years.

3 follow-up phase

After the initial 24-week period, the trial continues with ongoing monitoring to gather long-term data on the treatment’s effectiveness and safety.

The trial is expected to conclude by April 2028, with continuous evaluations to ensure comprehensive data collection.

Who Can Join the Study?

  • Sign and date a patient informed consent form, showing willingness to follow all study procedures and be available for the study duration.
  • Have adequate blood and organ function, as shown by specific lab test results taken within 7 days before starting the study treatment. This includes:
    • White blood cell count greater than 2000 per microliter.
    • Neutrophils (a type of white blood cell) greater than 1500 per microliter.
    • Platelets (cells that help with blood clotting) greater than 100,000 per microliter.
    • Hemoglobin (a protein in red blood cells) greater than 9.0 grams per deciliter.
    • Serum creatinine level (a measure of kidney function) less than 150 micromoles per liter.
    • Serum bilirubin (a substance made by the liver) less than or equal to 1.5 times the upper normal limit.
    • Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) levels less than or equal to 3 times the upper normal limit.
    • Prothrombin time (PT)/International normalized ratio (INR) and partial PT (PTT) less than or equal to 1.5 times the upper normal limit, unless on blood-thinning medication with stable INR.
  • Females who can have children must have a negative pregnancy test within 7 days before starting the study treatment.
  • Women who can have children should use effective birth control during treatment and for 5 months after. Men should use condoms during treatment and for 7 months after.
  • Be registered in a national health care system.
  • Be 18 years of age or older.
  • Have an ECOG Performance Status of 0, 1, or 2, which is a scale used to assess how a disease affects a patient’s daily living abilities.
  • Have colorectal adenocarcinoma confirmed by tissue examination.
  • Have advanced or metastatic disease that cannot be completely removed by surgery.
  • Have at least one measurable lesion as seen on a CT scan or MRI, and be able to have repeated imaging tests. If the lesion is in an area that was previously treated with radiation, it must show clear growth and be measurable.
  • Have a tumor with dMMR (deficient mismatch repair) and/or MSI (microsatellite instability) status, confirmed by specific tests. This includes:
    • Loss of MMR protein expression using specific antibodies, or
    • Two or more unstable markers by a specific PCR test, with confirmation of dMMR status if needed.
  • Have had no more than one prior line of systemic treatment for metastatic disease. If previous treatment was given before the cancer spread, it must have been completed more than 6 months before the cancer returned or spread.
  • Provide a sample of tumor tissue for research purposes, either as a tissue block or as unstained slides from the primary or metastatic site.

Who Cannot Join the Study?

  • Patients who do not have DMMR or MSI metastatic colorectal cancer cannot participate. DMMR means the cancer cells have a problem with repairing their DNA, and MSI means there are changes in the DNA that affect how the cancer grows.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined by the study, but it is not specified here.
  • Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, are not included.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centr Georges Francois Leclerc Dijon France
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France
Aix Marseille University Marseille France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Poitiers Poitiers France
Hopital Prive Jean Mermoz Lyon France
Centre Hospitalier Universitaire De Nantes Nantes France
IHFB Cognacq Jay Levallois-Perret France
Institut Sainte Catherine Avignon France
Hôpital Pontchaillou-CHU Rennes Rennes France
Cdfiah Hutobwvvelr Uswxxifunzebu Rhjgy Reims France
Itmcrvqe Mcsrspnyca Mzyjbaohss Paris France
Hxwnfjm Eycxppg &kgpajo Cdx dn Cgekynmgwluwkfdt Clermont Ferrand France
Heyaydd Sppcc Aasqces Paris France
Iymvqqjg Rfrvxmgc Dc Cwnluk Dm Mamuqyzulba Montpellier France
Bnvufjbp Uluvegkibm Hibpnrbe Cfnzpn Besançon France
Htoyqfz Hmekw Mblees &ecxmig 1 rgl Ghnugrr Eyhilz Creteil France

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

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
21.05.2021

Trial locations

Investigated drugs:

Nivolumab is a medication used in cancer treatment. It works by helping the immune system recognize and attack cancer cells more effectively. In this trial, it is being tested in combination with another medication to see how well it works in treating metastatic colorectal cancer.

Ipilimumab is another medication used in cancer therapy. It also helps the immune system fight cancer by targeting specific pathways that cancer cells use to avoid being attacked. In this study, it is combined with nivolumab to evaluate its effectiveness and safety in patients with a specific type of colorectal cancer.

Metastatic Colorectal Cancer – This is a type of cancer that begins in the colon or rectum and has spread to other parts of the body. It often progresses through stages, starting in the lining of the colon or rectum and potentially moving to nearby lymph nodes and distant organs, such as the liver or lungs. The disease can cause symptoms like changes in bowel habits, blood in the stool, and abdominal discomfort. As it advances, it may lead to more severe symptoms, including weight loss and fatigue. The progression of metastatic colorectal cancer can vary, with some cases spreading more rapidly than others.

Trial ID:
2024-518138-10-00
Protocol code:
NIPISAFE G-106
NCT ID:
NCT04730544
Trial Phase:
Therapeutic exploratory (Phase II)

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