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

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Verified Sites

Other Sites

Site Name City Country Status
Karolinska University Hospital Solna Sweden
Centre Hospitalier Universitaire De Nantes Nantes France
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Az Maria Middelares Gent Gent Belgium
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej Biala Podlaska Poland
Markhot Ferenc Oktatokorhaz Es Rendelointezet Eger Hungary
CHU Helora La Louviere Belgium
Instytut Centrum Zdrowia Matki Polki Lodz Poland
Institut Sainte Catherine Avignon France
Axadluytq Kawcxjzm Hrxdcod Gbgp Hamburg Germany
Ifwhpoqs Jamrn Bkzgcl Anderlecht Belgium
Sfkdasqelxogxsp Aq Stockholm Sweden
Hnapywzd Vyqe dwhehdub Barcelona Spain
Vldgbc dob Rovgj Ukrdbkvhrf Hvjxsbbm Sevilla Spain
Ronxzs Scgqf Szhzmc Uxynynrssbybfcxwdwv Lund Sweden
Ugmamovmecik Meqjjss Cfnouov Uzaodgv Utrecht The Netherlands
Uydepgc Urnoaqgqll Hbevtuow Uppsala Sweden
Cxqtcge Ugfijmpqespatqimgoaz Bvbcdu Kws Berlin Germany
Envavjr Ubijbjcvdroe Mueothr Cbfbhmp Rlilnmssu (ucesqkl Meo Rotterdam The Netherlands
Sxnjxgcxt Rqpgexo Ugzxteavsr Mfrxkeo Cveejp Nijmegen The Netherlands
Ufoehlrlvlpeswgohdnyz Hocjbuijkm Atp Heidelberg Germany
Khtqasdn dzq Uglxmjmebqck Miexgekx Atp Munich Germany
Utgrsjsrng Oa Srigxn Szeged Hungary
Uuzbujqdeqndyc Ccpkwrl Kenwbcokf Gdansk Poland
Huyyeaef Dr Lx Seygw Cxpf I Sojk Pbl Barcelona Spain
Uyosuyjfgg Oo Acjzrrs Edegem Belgium
Umprwmohixihctxzwtgkj Emuou Agj Essen Germany
Cycljv hiezhmqtfoa uesugfdkupmho dz Lgmgp Liege Belgium
Ittfnect ffih Kcsprcltm Tlhxzgiuoqwwlfkmtom uwd Ihscvgpkaqva Ubh gbroc Ulm Germany
Hrvdfcaj Uaevfkpstuexg 1s Dw Okyulbl Madrid Spain
Qcnzv Sxdaxn Cblcquycl Hozvrwfe &vktkwn Sltzfdkthko Uuyytfjnob Hfvpgxzu &plzxtq Vsttmyb Gasnjiwwezxvuumllb Gothenburg Sweden
Ayhahfjz Zrdeokbgcm Gqstagevf Kortrijk Belgium
Swmxjty Kpaoysygk Mvzxjzutcgxz Slzks Wvrbrlenqixj I Amddimmrdskwg Z Wwytnnaspcmsmdrbmss Cxwegau Ozlmycjyy W Oyjftauny Olsztyn Poland
Ftuabtgabi Igjvaalnxe Ipfygqyn Nfmfxhjxxcf Bgvpe Milan Italy
Aolzmyh Ovqkmhvgklr Uvzvkknioodqt Pdeuuh Pisa Italy
Kpcaibkvxlo Nsfzzmdo Gkif Frankfurt Germany
Iaqepeod Oavvignbnn Vdftkj Padua Italy
Itdmceba Rduytyqd Dw Cmxfvb Dv Mzraaskmovc Montpellier France
Hiafvht Pipkw Jcgd Mliqix Lyon France
Swlsgqmprg Eadkmnr Budapest Hungary
Mwbiesu Mfvzria Cjmszh Amersfoort The Netherlands
Sqn Ewrcozeks Hmmztarc Tmbdmty Tilburg The Netherlands
Nwweqrcv Ifllnexx Oeuizoxcb Icj Mwjcf Saecniymjngypcvwaitmnanlwpdg Idgklunl Bzsztdcq Cracow Poland
Ujpdbnbmry Oa Pfxf Pecs Hungary
Aepvlhg Udtyl Smjwrvkpa Lekcni Duapc Rozznwa Faenza Italy
Ngfmwxwdsou Cukutn Imehwtxpm Amsterdam The Netherlands
Cjurgs Htlztqspwkt Uwemdyljohhfu Dt Pwoxexpk Poitiers France
Ouewpyte Coctlaz Orcloiuft Iwz Pimgl Tkmnlocx Kaggvurqkktwrq W Oksrn Szjsnnaaxzg Pszwgthdi Zvmaet Oqnjbl Zjqjxletzg Opole Poland
Svshvbw Stkuccyvyhmrmyn W Bixclkxii Pmsmiieddah Oymfhcv Oagzxtksfvjo Isnfrzimstjvkrbtfia Brzozow Poland
Bfiayekovmon Cdpnmxa Ozynxvpcc Ixe Mqfqc Sinhnbibmzfepiberz W Bwclpyhyasb Bialystok Poland
Povvan Fghi Ictbuilenpfcftenoi Opstegwxn Ahe Hnbzrltpnppr Gqv Freiburg Im Breisgau Germany

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.

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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