Study Comparing Nivolumab, Nivolumab with Ipilimumab, or Chemotherapy for Patients with Metastatic Colorectal Cancer with High Microsatellite Instability

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What is this study about?

This clinical trial is focused on studying treatments for a type of cancer known as metastatic colorectal cancer, which is characterized by specific genetic features called Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR). The study is exploring the effectiveness of different treatments, including the use of Nivolumab alone, a combination of Nivolumab and Ipilimumab, and various chemotherapy options chosen by the investigator. Nivolumab is also known by its code name BMS936558.

The purpose of the study is to compare how well these treatments work in managing the cancer. Participants will receive one of the treatments, which are administered through an intravenous infusion, meaning the medication is given directly into a vein. The study will take place over a period of time, during which participants will receive regular treatments and be monitored by healthcare professionals. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the actual treatments.

Throughout the study, participants will undergo regular check-ups and assessments to monitor their health and the progress of the cancer. The study aims to provide valuable information on the effectiveness of these treatments, potentially leading to improved care for individuals with this type of colorectal cancer. The trial is expected to continue until 2026, with the goal of gathering comprehensive data on the outcomes of the different treatment options.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of metastatic colorectal cancer with certain genetic characteristics.

The study involves different treatment groups, and assignment to a group is randomized.

2 treatment group assignment

Participants are assigned to one of three groups: nivolumab alone, nivolumab with ipilimumab, or a chemotherapy regimen chosen by the investigator.

The assignment determines the specific treatment plan and schedule.

3 nivolumab treatment

If assigned to the nivolumab group, the treatment involves receiving OPDIVO (nivolumab) 10 mg/mL as a solution for infusion.

The medication is administered intravenously, following a schedule determined by the study protocol.

4 nivolumab and ipilimumab treatment

If assigned to the combination group, treatment includes both OPDIVO (nivolumab) 10 mg/mL and YERVOY (ipilimumab) 5 mg/mL.

Both medications are administered as solutions for infusion through an intravenous route, according to the study schedule.

5 chemotherapy treatment

If assigned to the chemotherapy group, treatment may include medications such as irinotecan hydrochloride trihydrate, fluorouracil, bevacizumab, and disodium folinate.

These medications are administered intravenously, with specific dosages and schedules determined by the investigator.

6 monitoring and assessments

Throughout the study, regular monitoring and assessments are conducted to evaluate the response to treatment.

Progression-free survival and overall response rates are key measures used to assess the effectiveness of the treatments.

7 completion of the study

The study is estimated to conclude by June 2026, with ongoing assessments and data collection until that time.

Participants may continue to receive treatment as per the study protocol until the study’s end or until specific criteria are met.

Who Can Join the Study?

  • The patient must have recurrent or metastatic colorectal cancer. This means the cancer has come back or spread to other parts of the body.
  • The cancer must be confirmed through a test called histology, which examines tissue under a microscope.
  • The patient must have a known tumor status of MSI-H (Microsatellite Instability High) or dMMR (Mismatch Repair Deficient). These are specific characteristics of the cancer cells.
  • The patient must have an ECOG performance status of 1 or lower. This is a scale that measures how well a patient can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • The patient must be at least 18 years old.
  • Both male and female patients can participate.
  • Other specific criteria defined in the study protocol may apply.

Who Cannot Join the Study?

  • Patients with other types of cancer that are not the specific type being studied.
  • Patients who have had a different treatment for their cancer that might interfere with the study.
  • Patients with serious health problems that could make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures for any reason.
  • Patients who have an allergy to the study medications.
  • Patients who have participated in another clinical trial recently.
  • Patients with certain infections that could affect the study results.
  • Patients who have had a recent surgery that could interfere with the study.
  • Patients with a history of certain heart conditions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Haematologisch Onkologische Praxis Eppendorf Hamburg Germany
Medical University Of Vienna Vienna Austria
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Oncopole Claudius Regaud Toulouse France
Technische Universitaet Dresden Dresden Germany
Katholieke Universiteit te Leuven Leuven Belgium
Oslo Universitetssykehus HF Oslo Norway
Medizinische Hochschule Hannover Hanover Germany

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Hopital Saint Antoine Paris France
Institut Jules Bordet Anderlecht Belgium
Philipps-Universitaet Marburg Marburg Germany
Hospital General Universitario De Valencia Valencia Spain
Netherlands Cancer Institute Amsterdam The Netherlands
Centre Hospitalier Universitaire De Poitiers Poitiers France
Masarykuv Onkologicky Ustav Brno-Stred Czechia
ARNAS Garibaldi Di Catania Catania Italy
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Spitalul Judetean De Urgenta Sfantul Ioan Cel Nou Suceava Suceava Romania
Landesklinikum Wiener Neustadt Vienna Austria
Institutul Regional De Oncologie Iasi Iasi Romania
Metropolitan General Hospital/Healthcare Facilities Operation And Management Single Member S.A Cholargos Greece
Virgen del Rocío University Hospital Sevilla Spain
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Centre Hospitalier Universitaire De Nantes Nantes France
University Hospital Olomouc Olomouc Czechia
Hospital Universitario 12 De Octubre Madrid Spain
Uniklinikum Salzburg Salzburg Austria
Asklepios Klinik Altona Hamburg Germany
Fundeni Clinical Institute Bucharest Romania
Iabpbcrg Rjekhehj Do Covmup Dj Mmpwlgiettt Montpellier France
Hkrta Bdrqpy Hy Bergen Norway
Mblmatt Uctkchqejr Oh Gpfq Graz Austria
Cjywtp Luke Biozrz Lyon France
Ibxijh Bonheiden Belgium
Cwlbzh Hfioyuacvpw Ez Uqggrqgdnilpp Dr Lzrtmad Limoges France
Hdfjhy Hmhnxtia Herlev Denmark
Azkhjrahym Povpwqxd Hblnence Dr Mwczsfjwb Marseille France
Aucssckz Uafhavvfxf Hdfnvorw Lorenskog Norway
Bnrvedye Uxustzgcer Hhkibnht Chjsjh Besançon France
Azdztphuw Ubk Amsterdam The Netherlands
Aoukyw Mqtvuim Cgjkjq Sjyu Thessaloniki Greece
Kclzygdr dwj Ugzbfskwivyi Mhwijatj Awn Munich Germany
Udqejkxgwtbnmjgxgbwdk Eprhv Atv Essen Germany
Hqdvtelm Ukeizqvbgsnnz Husmnvxh Tefuy y Ppiyco Ivdgrous Cdbvty dmapmxpvxcmlukffw (gkic Badalona Spain
Hqpojcgy Vmna diojmapq Barcelona Spain
Cixibj Ozjbb Lqszuef Lille France
Hvyemrqd Uqrcxgktqtpav dk A Ckxdic A Coruna Galicia Spain
Kazcoat Dbw Bmmfbmqciehc Bphuxlo Linz Austria

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
06.09.2019
Belgium Belgium
Not recruiting
06.09.2019
Czechia Czechia
Not recruiting
06.09.2019
Denmark Denmark
Not recruiting
06.09.2019
France France
Not recruiting
06.09.2019
Germany Germany
Not recruiting
06.09.2019
Greece Greece
Not recruiting
06.09.2019
Italy Italy
Not recruiting
06.09.2019
Norway Norway
Not recruiting
06.09.2019
Romania Romania
Not recruiting
06.09.2019
Spain Spain
Not recruiting
06.09.2019
The Netherlands The Netherlands
Not recruiting
06.09.2019

Trial locations

Nivolumab is a medication used in this trial to treat metastatic colorectal cancer. It works by helping the immune system recognize and attack cancer cells more effectively. Nivolumab is often used in cancers that have specific genetic features, such as microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR).

Ipilimumab is another medication used in combination with Nivolumab in this trial. It also helps the immune system fight cancer by targeting a different part of the immune response. When used together with Nivolumab, it may enhance the overall effectiveness of the treatment against cancer cells.

Investigator’s Choice Chemotherapy refers to a standard chemotherapy treatment selected by the trial investigator. This treatment is used as a comparison to evaluate the effectiveness of Nivolumab alone or in combination with Ipilimumab. Chemotherapy works by using drugs to kill or slow the growth of cancer cells.

Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient Metastatic Colorectal Cancer (dMMR) – This type of colorectal cancer is characterized by genetic mutations that affect the DNA repair process, leading to high levels of microsatellite instability. It often begins in the colon or rectum and can spread to other parts of the body. The disease progresses as cancer cells grow uncontrollably, forming tumors that can invade nearby tissues and organs. Patients with this condition may experience symptoms such as changes in bowel habits, abdominal pain, and weight loss. The progression of the disease can vary, with some tumors growing slowly while others may advance more rapidly. Understanding the genetic basis of this cancer is crucial for developing targeted therapies.

Trial ID:
2023-503956-29-00
Protocol code:
CA209-8HW
Trial Phase:
Therapeutic confirmatory (Phase III)

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