Study Comparing Amivantamab and Drug Combination for Patients with Recurrent or Metastatic Colorectal Cancer Without KRAS/NRAS and BRAF Mutations

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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 in cases where the cancer has returned, cannot be surgically removed, or has spread to other parts of the body. The study is particularly interested in patients whose cancer does not have certain genetic mutations, specifically KRAS, NRAS, and BRAF wild-type mutations. The trial will explore the effectiveness of a new treatment combination involving a medication called Amivantamab and a chemotherapy regimen known as FOLFIRI, compared to another treatment combination using Cetuximab or Bevacizumab with FOLFIRI.

The purpose of the study is to compare how well these treatment combinations work in controlling the cancer. Participants will receive one of the treatment combinations and will be monitored over time to see how their cancer responds. The study will involve regular visits to the clinic for treatment and assessments, which will include various tests to check the progress of the cancer and the overall health of the participants.

Throughout the study, participants will receive their treatments through an infusion, which means the medication will be given directly into a vein. The study aims to provide valuable information on which treatment combination might be more effective for patients with this specific type of colorectal cancer. The trial will continue until enough information is gathered to make a clear comparison between the two treatment options.

1 initial assessment

The initial assessment involves confirming the diagnosis of colorectal cancer. The cancer must be of a specific type, known as KRAS/NRAS and BRAF wild-type, and must be recurrent, cannot be surgically removed, or has spread to other parts of the body.

Eligibility is determined by previous treatment history, specifically having received one line of systemic therapy for metastatic colorectal cancer, with documented disease progression.

2 randomization

Participants are randomly assigned to one of two treatment groups. This process ensures that each participant has an equal chance of receiving either treatment option.

3 treatment administration

Participants in the first group receive amivantamab in combination with a chemotherapy regimen known as FOLFIRI. Amivantamab is administered via subcutaneous injection.

Participants in the second group receive a combination of cetuximab and bevacizumab with FOLFIRI. Both cetuximab and bevacizumab are administered through intravenous infusion.

The frequency and dosage of these medications are determined by the study protocol and are administered under medical supervision.

4 monitoring and follow-up

Regular monitoring is conducted to assess the effectiveness of the treatment and to check for any side effects. This includes imaging tests and other assessments as required by the study protocol.

Participants are monitored for progression-free survival (PFS) and overall survival (OS) as primary endpoints of the study.

5 completion of study

The study is estimated to conclude by October 2029. Participants will continue to be monitored until the study’s end date or until they meet criteria for discontinuation.

Who Can Join the Study?

  • Must have a confirmed diagnosis of a type of cancer called adenocarcinoma of the colon or rectum. This means the cancer started in the glandular cells of these areas.
  • The cancer must be recurrent (has come back), unresectable (cannot be removed by surgery), or metastatic (has spread to other parts of the body).
  • The tumor must be of a specific type called KRAS, NRAS, and BRAF wild-type, which means it does not have certain genetic mutations.
  • Must have already received one type of treatment for metastatic colorectal cancer and have shown disease progression, meaning the cancer has continued to grow or spread.
  • Must be 18 years or older and have a performance status of 0-1 on the ECOG scale, which measures how well a person can perform daily activities.
  • Must have at least one measurable tumor according to a standard called RECIST v1.1, which is a way to measure how tumors respond to treatment.
  • Must have adequate function of organs and bone marrow, meaning the organs and bone marrow are working well enough to participate in the study.

Who Cannot Join the Study?

  • Patients with a type of colorectal cancer that is not KRAS/NRAS and BRAF Wildtype. This means the cancer has specific genetic characteristics that are not suitable for the study.
  • Patients whose cancer is not recurrent, meaning it has not come back after treatment.
  • Patients whose cancer is not unresectable, meaning it can be removed by surgery.
  • Patients whose cancer is not metastatic, meaning it has not spread to other parts of the body.

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
Institut Jules Bordet Anderlecht Belgium
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centre hospitalier universitaire de Liege Liege Belgium
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Hospital Universitari Dexeus Grupo Quironsalud Barcelona Spain
ARNAS Garibaldi Di Catania Catania Italy
Az Maria Middelares Gent Gent Belgium
Instytut Centrum Zdrowia Matki Polki Lodz Poland
Delta Health Care S.R.L. Bucharest Romania
Centrul Medical Unirea S.R.L. Brasov Romania
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
Pelican Impex S.R.L. Oradea Romania
Mnt Healthcare Europe S.R.L. Pantelimon Romania
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej Biala Podlaska Poland
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Institutul Regional De Oncologie Iasi Iasi Romania
Virgen del Rocío University Hospital Sevilla Spain
Region Skane Skanes Universitetssjukhus Lund Sweden
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Karolinska University Hospital Solna Sweden
Stichting Radboud University Medical Center Nijmegen The Netherlands
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Meander Medical Center Amersfoort The Netherlands
Universita’ Di Pisa Pisa Italy
Markhot Ferenc Oktatokorhaz Es Rendelointezet Eger Hungary
Oncomed S.R.L. Timisoara Romania
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
University Of Pecs Pecs Hungary
Spitalul De Oncologie Monza S.R.L. Bucharest Romania
CHU Helora La Louviere Belgium
Netherlands Cancer Institute Amsterdam The Netherlands
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
Soedersjukhuset AB Stockholm Sweden
Hnqbhiht Uiboeaqoqoaie Dv Bcmqgqb Badajoz Spain
Uajuabq Uwiyhbkbnu Hhxmkkfs Uppsala Sweden
Etuocxu Uziphexnaodm Mwjrppj Ckojscv Rzbpianpy (edrtccy Mro Rotterdam The Netherlands
Sht Etmcokbco Hrvbszcz Tirpias Tilburg The Netherlands
Ncjpwcmx Igkhmcst Odpypfgwl Iga Mkxuf Srsndtyiuevlbpdjihhpkhvqfvzd Ivkedvxa Bhqedpxi Cracow Poland
Kloijcmp dmq Udbecgmhpvqa Mtvywwjx Aol Munich Germany
Ukbnaytdzyqbxf Cnfdpta Khwanxuqk Gdansk Poland
Hqfnfghf Dy Lm Skyul Ceve I Sace Pzl Barcelona Spain
Usilcekqfz Oa Aqohiwm Edegem Belgium
Hhslvket Vmrp dbmyhtyq 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
03.02.2025
France France
Recruiting
03.02.2025
Germany Germany
Recruiting
03.02.2025
Hungary Hungary
Not recruiting
03.02.2025
Italy Italy
Recruiting
03.02.2025
Poland Poland
Recruiting
03.02.2025
Romania Romania
Recruiting
03.02.2025
Spain Spain
Recruiting
03.02.2025
Sweden Sweden
Recruiting
03.02.2025
The Netherlands The Netherlands
Recruiting
03.02.2025

Trial locations

Amivantamab is a medication used in this trial to treat colorectal cancer. It works by targeting specific proteins on cancer cells, helping to slow down or stop their growth.

FOLFIRI is a combination of chemotherapy drugs used to treat colorectal cancer. It includes three medications: folinic acid, fluorouracil, and irinotecan. These drugs work together to kill cancer cells or stop them from growing and dividing.

Cetuximab is a medication that targets a specific protein on the surface of cancer cells. It helps to slow down or stop the growth of cancer cells in colorectal cancer.

Bevacizumab is a medication that works by blocking the blood supply to tumors. This can help to slow down the growth of cancer cells in colorectal cancer.

Investigated diseases:

Colorectal Cancer – Colorectal cancer is a type of cancer that begins in the colon or rectum, parts of the large intestine. It often starts as small, noncancerous clumps of cells called polyps that form on the inside of the colon. Over time, some of these polyps can become cancerous. The disease can spread to other parts of the body if not detected early. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort. The progression of the disease can vary, with some cases remaining localized while others may become more advanced.

Trial ID:
2024-513853-66-00
Protocol code:
61186372COR3002
Trial Phase:
Therapeutic confirmatory (Phase III)

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