Study Comparing Amivantamab and Chemotherapy Versus Cetuximab and Chemotherapy for Patients with Advanced Colorectal Cancer

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What is this study about?

This clinical trial is focused on studying a type of cancer known as colorectal cancer, specifically when it is located on the left side of the colon and cannot be surgically removed or has spread to other parts of the body. The study is particularly interested in cases where the cancer does not have certain genetic mutations, specifically KRAS, NRAS, and BRAF mutations. The trial will compare two different treatment approaches to see which is more effective as a first-line treatment for this type of cancer.

Participants in the study will receive one of two treatment combinations. The first group will receive a medication called Amivantamab along with chemotherapy drugs known as mFOLFOX6 or FOLFIRI. The second group will receive a medication called Cetuximab along with the same chemotherapy options, mFOLFOX6 or FOLFIRI. Amivantamab is given as a solution for injection under the skin, while Cetuximab is administered as a solution for infusion into a vein. Some participants may receive a placebo, which looks like the real treatment but does not contain the active medication.

The purpose of the study is to compare the effectiveness of these treatments in terms of how long they can prevent the cancer from getting worse. Participants will be randomly assigned to one of the treatment groups and will receive their assigned treatment over a period of time. The study will monitor the progress of the cancer using standard medical assessments to determine which treatment combination is more effective. The trial is expected to continue until 2028, with recruitment starting in 2025.

1 joining the study

Upon joining the study, you will be randomly assigned to one of two treatment groups. This means you will either receive amivantamab with chemotherapy or cetuximab with chemotherapy.

The study aims to compare the effectiveness of these treatments in patients with a specific type of colorectal cancer.

2 treatment administration

If you are in the amivantamab group, you will receive this medication through an injection under the skin. The exact dosage and frequency will be explained to you by the medical team.

If you are in the cetuximab group, you will receive this medication through an infusion into a vein. The dosage is 5 mg/mL, and the frequency and duration will be provided by the medical team.

3 chemotherapy

Both groups will receive chemotherapy, which may include mFOLFOX6 or FOLFIRI. These are combinations of drugs used to treat cancer, and the medical team will provide specific details about the dosage and schedule.

4 monitoring and assessments

Throughout the study, regular monitoring and assessments will be conducted to evaluate your health and the effectiveness of the treatment. This includes scans and tests to measure the size of the tumor.

The study will use a standard method called RECIST v1.1 to assess the tumor’s response to treatment.

5 end of study participation

Your participation in the study will continue until the study’s estimated end date in December 2028, or until the medical team decides it is appropriate for you to stop.

At the end of your participation, a final assessment will be conducted to gather information about your health and the treatment’s impact.

Who Can Join the Study?

  • Have a confirmed diagnosis of adenocarcinoma, a type of cancer, in the left side of the colon that cannot be removed by surgery or has spread to other parts of the body.
  • Have a tumor that is KRAS, NRAS, and BRAF Wild-type (WT), meaning it does not have certain genetic mutations. This must be confirmed by a test on tissue or blood.
  • Agree to provide a new sample of the tumor tissue for testing.
  • Have a tumor that can be measured using a standard method called RECIST v1.1. If there is only one tumor that can be measured, it can be used for a biopsy, but scans to assess the tumor must be done at least 7 days after the biopsy.
  • Have an ECOG Performance Status (PS) of 0 or 1, which means you are fully active or have some symptoms but can still carry out light work.
  • Have not received any previous treatment with drugs for colorectal cancer that cannot be removed by surgery or has spread.
  • Be within the age range of 18 to 64 years old.
  • Both males and females can participate.

Who Cannot Join the Study?

  • Patients with a type of cancer that is not KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Krankenhaus Nordwest GmbH Frankfurt Germany
Istituto Oncologico Veneto Padua Italy
Asklepios Kliniken Hamburg GmbH Hamburg Germany
Institut Jules Bordet Anderlecht Belgium
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centre hospitalier universitaire de Liege Liege Belgium
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Soedersjukhuset AB Stockholm Sweden
Az Maria Middelares Gent Gent Belgium
Instytut Centrum Zdrowia Matki Polki Lodz Poland
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej Opole Poland
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza Brzozow Poland
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie Olsztyn Poland
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku Bialystok Poland
Praxis Fuer Interdisziplinaere Onkologie And Haematologie GbR Freiburg Im Breisgau Germany
Hospital Universitario Ramon Y Cajal Madrid Spain
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej Biala Podlaska Poland
Hopital Prive Jean Mermoz Lyon France
Hospital Clinico Universitario De Valencia Valencia Spain
Virgen del Rocío University Hospital Sevilla Spain
Region Skane Skanes Universitetssjukhus Lund Sweden
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Karolinska University Hospital Solna Sweden
Stichting Radboud University Medical Center Nijmegen The Netherlands
Meander Medical Center Amersfoort The Netherlands
Universita’ Di Pisa Pisa Italy
Markhot Ferenc Oktatokorhaz Es Rendelointezet Eger Hungary
Centre Hospitalier Universitaire De Nantes Nantes France
University Of Pecs Pecs Hungary
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
CHU Helora La Louviere Belgium
Netherlands Cancer Institute Amsterdam The Netherlands
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Hopital Beaujon Clichy France
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Institut Sainte Catherine Avignon France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
University Of Szeged Szeged Hungary
Idsakxll Rlsrkrkq Df Chhdmg Dj Mrjkfylnfav Montpellier France
Soxzlawudj Edlixmx Budapest Hungary
Uqairgzwlmsmfqnvcttpj Ehkwy Aht Essen Germany
Uxrgzgu Udplwzlbax Hclagfkl Uppsala Sweden
Ecwuucv Ubcxgcbcoiue Mogizcm Cwkmnke Rgxjelkra (wfsitta Mho Rotterdam The Netherlands
Sjh Esvjgbrew Hswfseys Teaqeny Tilburg The Netherlands
Nhfuahzl Ijohytid Oejcdkfdy Imj Mtauj Sozhkqgpnysxwavjvfdvpfgleuvh Irnhtjwx Bsaryuvw Cracow Poland
Kgjcesly dkx Uvnivlqxcwor Mduuerpx Aen Munich Germany
Uvhflzvpnmamta Cnbserr Kjdhfsogh Gdansk Poland
Hnjfvokh Dy Lq Skenb Cxtm I Stwe Pix Barcelona Spain
Ussgjsdenx Or Aofkort Edegem Belgium
Hcqbupog Vuuu dnqzncin Barcelona Spain

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
02.01.2025
France France
Recruiting
02.01.2025
Germany Germany
Recruiting
02.01.2025
Hungary Hungary
Recruiting
02.01.2025
Italy Italy
Recruiting
02.01.2025
Poland Poland
Recruiting
02.01.2025
Spain Spain
Recruiting
02.01.2025
Sweden Sweden
Recruiting
02.01.2025
The Netherlands The Netherlands
Recruiting
02.01.2025

Trial locations

Investigated drugs:

Amivantamab is a medication used in this clinical trial to treat certain types of colorectal cancer. It works by targeting specific proteins on cancer cells, which can help slow down or stop the growth of the cancer. This medication is being tested to see if it can be an effective first-line treatment for patients with a specific type of colorectal cancer that cannot be removed by surgery or has spread to other parts of the body.

mFOLFOX6 is a combination of chemotherapy drugs used to treat colorectal cancer. It includes several medications that work together to kill cancer cells or stop them from growing. This therapy is often used as a standard treatment for colorectal cancer and is being tested in this trial to see how well it works in combination with other treatments.

FOLFIRI is another combination of chemotherapy drugs used to treat colorectal cancer. Like mFOLFOX6, it includes multiple medications that work together to attack cancer cells. This therapy is also a standard treatment option for colorectal cancer and is being evaluated in this trial to determine its effectiveness when used with other therapies.

Cetuximab is a medication that targets specific proteins on the surface of cancer cells. By binding to these proteins, it can help slow down or stop the growth of the cancer. Cetuximab is used in this trial to see if it can be an effective treatment option for patients with a certain type of colorectal cancer, either alone or in combination with other therapies.

Investigated diseases:

KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer – This type of colorectal cancer occurs in the left side of the colon and is characterized by the absence of mutations in the KRAS, NRAS, and BRAF genes. It is considered unresectable, meaning it cannot be removed surgically, or metastatic, indicating that it has spread to other parts of the body. The disease typically begins in the cells lining the colon and can progress to invade nearby tissues and organs. As the cancer advances, it may cause symptoms such as changes in bowel habits, abdominal pain, and weight loss. The progression of the disease can vary, with some cases remaining localized while others spread more extensively.

Trial ID:
2024-513852-13-00
Protocol code:
61186372COR3001
Trial Phase:
Therapeutic confirmatory (Phase III)

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