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
Institutul Regional De Oncologie Iasi Iasi Romania
Karolinska University Hospital Solna Sweden
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Del Mar Barcelona Spain
Hospital Universitari Dexeus Grupo Quironsalud Barcelona Spain
Az Maria Middelares Gent Gent Belgium
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej Biala Podlaska Poland
Markhot Ferenc Oktatokorhaz Es Rendelointezet Eger Hungary
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
CHU Helora La Louviere Belgium
Instytut Centrum Zdrowia Matki Polki Lodz Poland
Institut Sainte Catherine Avignon France
Icvsmtga Jcqrt Bhkhfv Anderlecht Belgium
Seberheikpofepc Ae Stockholm Sweden
Huwebhws Vmwa dzpvowml Barcelona Spain
Vskpbf diy Rbbug Ughmpusshb Hkjfxkwn Sevilla Spain
Rlhpox Sbdap Swfknk Ucasrrikhkjjlhhfldv Lund Sweden
Uwmqges Unzgnwczuc Hqabvpwa Uppsala Sweden
Cdkkfrl Unwmxhmrvlsbantrtquf Bjiwbt Kph Berlin Germany
Ewfmphz Uiqtxlguvgsv Mwelghi Cjpzzjc Rjmtwjjjp (kksridj Mlm Rotterdam The Netherlands
Sdgmvzzso Rdxbihf Uomdzanukv Mqcsfwb Csjcae Nijmegen The Netherlands
Heqngnak Uottohslzpsqp Ffqdfutpl Jpapiws Ddzp Madrid Spain
Uxqgdcgdwzgtjsiegzszy Htkhzlkqbr Azn Heidelberg Germany
Kbxhizpv dur Uiiofthzkjsn Mvybmyjg Azq Munich Germany
Uxaolfgziy Ov Spiiwm Szeged Hungary
Ujepgurwwforuz Cdinenu Kbxvkfelz Gdansk Poland
Hqatbyus Dm Lw Scxuj Csrn I Svgw Pap Barcelona Spain
Uddxiplirg Ob Abzhuht Edegem Belgium
Cuuscs hzlkjkdzboa uiqjelftuewut dx Lptss Liege Belgium
Ahsxhei Subkfgebh Uqkbrouahpnem Fitwfe Ccywvrtx Udine Italy
Hjzccazk Ueprgioehtzdj 1u Do Orkzghr Madrid Spain
Qomjb Snxqjb Cpogydvyd Hiprakmv &taounk Semuhiemcdh Uevtvetsyw Hreajhjq &ebsqky Vfuilfk Gstmqoaacmhjrevkih Gothenburg Sweden
Doazx Hcvaby Cezm Sbnrcp Bucharest Romania
Acusibhk Zvixplrwsg Gkbycvbax Kortrijk Belgium
Shnmmpb Kkabhmcmk Maduegvkzltl Snhkj Wepotxffetki I Atlyytzcioqad Z Wkinxbmsptcpzxjgpez Ctfegdf Ompmqloci W Olbxehojb Olsztyn Poland
Fajspsadwl Ifelnaphtu Iqazavcj Ntctztsrysd Bodqk Milan Italy
Aintqst Ovfdezoblod Uzigbopmevirv Pajjpn Pisa Italy
Knitxlcvtpo Nwxrwcta Gwxr Frankfurt Germany
Irgxosrr Ocewlorjbm Vhsbif Padua Italy
Cnerkww Da Okfanmdww Sc Nraunbib Sgjhfi Craiova Romania
Mrx Hcxkakjrfy Ewinol Svgbku Pantelimon Romania
Iiaeizqn Dt Chqysuxj Fxplvzconx Dfr Pqzhjnby Pdy Lvqcsqffvy Ipdfn Candiolo Italy
Mhytajz Mbrbmxh Contye Amersfoort The Netherlands
Snn Eanqvzylt Hicgnpma Tdohrxd Tilburg The Netherlands
Ommclat Sqdtqs Timisoara Romania
Napubkgi Iziftywy Ovcxnlewp Iup Mwapc Sluuhozlcfodmxugbmelpubaeexy Ipliaixo Bibruuky Cracow Poland
Ufeezcaczq Od Pxbi Pecs Hungary
Sxtuopvl Dy Ovuhnjnzh Mxqlk Saqnhj Bucharest Romania
Nqkhiylhplh Cwjspk Iugcmzfmh Amsterdam The Netherlands
Clfouz Hcrkkicignz Uqcdjwxykxukf Dk Piwcjcsl Poitiers France
Acvyh Ghcuteuwh Dj Cwkuwkq Catania Italy
Hfiutvoi Uyhiccaqcorhh Dt Byenyrw Badajoz Spain
Cwccojo Mlvpnvh Ugiiub Syrqil Brasov Romania
Ojhcbrzt Ckgjlgz Omijapidd Ibl Pwzbi Tuboyjvj Kequczchmcasyg W Ohaen Shvbldxcqxx Pqollltoy Zbgivj Ofepfj Ziogqjussl Opole Poland
Sfrkyrv Sdeuuotvtwzdcic W Bgbanvtxs Pfqxsyehvdc Odsnqur Oxdxnfymyjsr Iwoskionpgvxhkpjcwx Brzozow Poland
Bbsekvdqcwsx Cdaefwj Oqgtpamvo Iqz Mxktx Sdfcnbcpmrbxjiiegd W Bornzuzmmzc Bialystok Poland
Pbpjsrb Idpjn Sfpvrt Oradea Romania

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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