Study of Pembrolizumab with Drug Combination for Patients with Microsatellite Stable Metastatic Colorectal Cancer with High Immune Infiltrate

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What is this study about?

This clinical trial is focused on studying the treatment of microsatellite stable metastatic colorectal cancer, a type of colon cancer that has spread to other parts of the body and does not have changes in certain DNA sequences. The study involves a combination of treatments, including chemotherapy and immunotherapy. The chemotherapy regimen includes XELOX, which is a combination of two drugs: capecitabine and oxaliplatin. Additionally, the study uses bevacizumab, a medication that helps prevent the growth of blood vessels that feed tumors. The immunotherapy component involves pembrolizumab, also known by its code name MK-3475, which helps the immune system recognize and attack cancer cells.

The purpose of this study is to evaluate how effective this combination of treatments is as a first-line therapy for patients with this specific type of colorectal cancer that shows a high level of immune cells within the tumor. The study will monitor patients over a period of time to see how many remain alive and without disease progression after 10 months. This is a non-randomized, multicenter study, meaning that all participants will receive the same treatment, and the study is conducted at multiple locations.

Participants in the study will receive the treatments through intravenous infusions, which means the medications are delivered directly into the bloodstream through a vein. The study will last for up to 24 months, during which time the patients’ health and response to the treatment will be closely monitored. The study aims to provide valuable insights into the effectiveness of combining chemotherapy and immunotherapy for treating this type of cancer.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and conducting necessary tests to ensure the patient meets the inclusion criteria.

2 treatment initiation

The treatment begins with the administration of pembrolizumab through an intravenous infusion. This medication is part of the immunotherapy approach.

In addition, bevacizumab is administered via intravenous infusion. This medication is used to inhibit the growth of blood vessels that supply the tumor.

3 chemotherapy administration

Oxaliplatin is given through an intravenous infusion. This is a chemotherapy drug that helps to kill cancer cells.

Capecitabine is taken orally in the form of film-coated tablets. This medication is also a chemotherapy drug and is taken as prescribed by the healthcare provider.

4 ongoing treatment

The treatment regimen continues with regular administration of the medications. The frequency and dosage are determined by the healthcare provider based on the patient’s response and tolerance to the treatment.

5 monitoring and evaluation

Throughout the trial, regular monitoring is conducted to evaluate the effectiveness of the treatment. This includes imaging studies and other tests to assess the progression of the cancer.

The primary goal is to determine the percentage of patients who are alive and without progression at 10 months.

6 completion of trial

The trial is expected to conclude by June 2026. At the end of the trial, a final assessment is conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who Can Join the Study?

  • Must be 18 years or older.
  • Must have adequate liver function:
    • AST/ALT levels should be less than or equal to 5 times the upper limit of normal (ULN).
    • Total bilirubin should be less than or equal to 2 times the ULN.
    • Alkaline phosphatase should be less than or equal to 5 times the ULN.
  • Must have a creatinine clearance greater than 50 mL/min, which is a measure of kidney function.
  • Must have proteinuria (protein in urine) less than 2+ on a dipstick test or less than or equal to 1 gram in a 24-hour urine collection.
  • Must be a beneficiary of the social security system.
  • Must have received information about the study and signed the informed consent form.
  • Must have both MSS and pMMR metastatic colorectal adenocarcinoma, which means a specific type of colorectal cancer that has spread to other parts of the body.
  • Patients who had chemotherapy or radiotherapy after surgery for their primary tumor can join if their cancer returned more than 6 months after treatment.
  • Must have a high immune response, which is determined by a test on the primary tumor.
  • Must have unresectable cancer with at least one measurable metastatic target, meaning the cancer cannot be removed by surgery and can be measured by specific criteria.
  • Must have a WHO performance status of 1 or less, which indicates the ability to carry out daily activities.
  • Must not have severe neuropathy (nerve damage) of grade 2 or higher.
  • Must have a life expectancy of more than 3 months.
  • Must have adequate blood function:
    • Neutrophils (a type of white blood cell) greater than 1,500 per mm3.
    • Platelets (cells that help with blood clotting) greater than 100,000 per mm3.
    • Hemoglobin (a protein in red blood cells) greater than 9 g/dL.

Who Cannot Join the Study?

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have had previous treatments that might interfere with the study.
  • Patients with serious health conditions that could make it unsafe to participate.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures for any reason.
  • Patients who have allergies to the study medications.
  • Patients who are participating in another clinical trial.
  • Patients who have had a recent major surgery.
  • Patients with infections that are not well controlled.
  • Patients with a history of certain heart problems.

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 De Beziers Beziers France
CHU d’Estaing Clermont Ferrand France
Hopital Prive Saint Claude St Quentin France
Institut De Cancerologie De Lorraine Vandoeuvre Les Nancy France
Centre Hospitalier Lyon Sud Pierre Benite France
Clinique de Flandre Coudekerque Branche France
Hôpital Européen Georges-Pompidou Paris France
Centre Hospitalier Intercommunal Creteil Creteil France
Comite Entreprise Paul Papin Angers France
Centre Hospitalier Universitaire De Lille Lille France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Aix Marseille University Marseille France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Hopital Saint Antoine Paris France
Centre Hospitalier Universitaire Rouen Rouen France
Hospital Foch Suresnes France
Centre Hospitalier Universitaire De Nimes Nimes France
Centre Hospitalier Prive Saint-Gregoire Saint-Gregoire France
Clinique Pasteur Lanroze Brest France
Institut Godinot Reims France
Clinique De L’infirmerie Protestante De Lyon Caluire Et Cuire France
Polyclinique De Blois La Chaussee St Victor France
Centre Hospitalier De Perpignan Perpignan France
Centre Hospitalier De Valenciennes Valenciennes France
Clinique Tivoli Ducos Bordeaux France
Hopital Europeen Marseille Marseille France
Clinique Medico Chirurgicale Charcot Sainte-Foy-Les-Lyon France
Centre Hospitalier D Avignon Avignon France
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer Toulon France
Hopital Prive Jean Mermoz Lyon France
Centre Paul Strauss STRASBOURG, Alsace France
Clinique de l’Europe Amiens France
Centre Hospitalier De La Cote Basque Bayonne France
Hopital Saint Joseph Marseille France
Groupe Hospitalier Bretagne Sud Lorient France
Centre Hospitalier De Cholet Cholet France
Hopital Prive Des Cotes D’armor Plerin France
Hopital Prive D Antony Antony France
Grand Hopital De L Est Francilien Meaux France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier De Boulogne Sur Mer Boulogne sur Mer France
Groupe Hospitalier Diaconesses Croix Saint Simon Paris France
Hopitaux Drome Nord Romans-Sur-Isere France
Centre Hospitalier Simone Veil De Beauvais Beauvais France
Polyclinique Bordeaux Nord Aquitaine Bordeaux France
Centre Hospitalier Universitaire De Poitiers Poitiers France
IHFB Cognacq Jay Levallois-Perret France
Institut Sainte Catherine Avignon France
Immobiliere De Nancy Nancy France
Hospital Paul Brousse Villejuif France
Centre Francois Baclesse Caen France
Centre Hospitalier De Pau Pau France
Hôpital Pontchaillou-CHU Rennes Rennes France
Groupe Hospitalier Rance Emeraude Saint-Malo France
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Cxqbci Hvunwphchkz Ef Umvmhpelzdufc Dc Lqxkofs Limoges France
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Iaoohiml dz Cufzcixeevyw Hjwjehtwiww Uosuinlekbgoh do Sgatu Ehvomph (nutxrwx Saint Priest En Jarez France
Hcspqfj Pwjkv Lq Bovi – Rstizk Stiat Lille France
Huwpbyud Uozqqljboctudi Swzatqkwre &liwurm Hrmdkpt ds Hrtepwbpeni STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
France France
Recruiting
20.04.2021

Trial locations

Pembrolizumab is a type of immunotherapy that helps the body’s immune system fight cancer cells. It works by blocking a specific protein on the surface of immune cells, allowing them to better recognize and attack cancer cells.

XELOX is a combination of two chemotherapy drugs, capecitabine and oxaliplatin. Capecitabine is taken orally and is converted into a substance that interferes with the growth of cancer cells. Oxaliplatin is given intravenously and works by damaging the DNA of cancer cells, preventing them from dividing and growing.

Bevacizumab is a medication that targets and inhibits a protein called vascular endothelial growth factor (VEGF). By blocking VEGF, bevacizumab helps prevent the growth of new blood vessels that tumors need to grow and spread.

Microsatellite Stable (MSS) Metastatic Colorectal Cancer – This type of colorectal cancer is characterized by the absence of microsatellite instability, meaning the DNA repair system is functioning normally. It is a form of cancer that has spread beyond the colon or rectum to other parts of the body. The disease often presents with a high immune infiltrate, indicating a significant presence of immune cells within the tumor. As the cancer progresses, it may lead to symptoms such as changes in bowel habits, abdominal pain, and weight loss. The progression of the disease is typically monitored through imaging studies to assess tumor growth and spread.

Trial ID:
2024-515788-73-00
Protocol code:
FFCD1703
NCT ID:
NCT04262687
Trial Phase:
Therapeutic exploratory (Phase II)

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