Recruiting

Study of Amivantamab and Chemotherapy Drug Combination for Patients with Advanced or Metastatic Colorectal Cancer

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying advanced or metastatic colorectal cancer, which is a type of cancer that affects the colon or rectum and has spread to other parts of the body. The study will explore the effects of a treatment called amivantamab, both on its own and in combination with standard chemotherapy treatments. Chemotherapy is a common cancer treatment that uses drugs to kill cancer cells. The chemotherapy drugs involved in this study include fluorouracil, oxaliplatin, irinotecan hydrochloride trihydrate, and folinic acid, also known as calcium folinate.

The purpose of the study is to evaluate how well amivantamab works against tumors and to understand its safety when used with standard chemotherapy. Participants will receive the treatments through intravenous use, meaning the medication is given directly into a vein. The study will help determine the best dose of amivantamab to use in combination with chemotherapy for future treatments.

Participants in the study will receive either the new treatment or a placebo, which is a substance with no active medication. The study will monitor the participants' response to the treatment and any side effects they may experience. This research aims to improve treatment options for people with advanced or metastatic colorectal cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, you will attend an initial visit. During this visit, a healthcare professional will explain the study procedures and answer any questions you may have.
You will be asked to sign an informed consent form, indicating your understanding and willingness to participate in the study.
Step 2
Screening tests
You will undergo a series of screening tests to confirm your eligibility for the study. These tests may include blood tests, imaging scans, and a biopsy of your tumor.
A pregnancy test will be conducted for female participants of childbearing potential.
Step 3
Treatment phase 1b
If eligible, you will begin the treatment phase. In Phase 1b, you will receive amivantamab as a monotherapy. This medication is administered through an intravenous infusion.
The dosage and frequency of administration will be determined by the study team based on your specific needs.
Step 4
Treatment phase 2
In Phase 2, amivantamab will be combined with standard-of-care chemotherapy. The chemotherapy regimen includes oxaliplatin, fluorouracil, irinotecan hydrochloride, and folinic acid, all administered intravenously.
The study team will provide specific details on the dosage and schedule of these medications.
Step 5
Regular monitoring
Throughout the study, you will have regular visits to monitor your health and the effects of the treatment. This includes physical exams, blood tests, and imaging scans.
You will be asked to report any side effects or changes in your condition to the study team.
Step 6
End of treatment
At the end of the treatment period, you will have a final evaluation to assess your response to the therapy.
The study team will discuss the results with you and provide guidance on any further steps or follow-up care needed.

Who can join the trial?

16 criteria

Participant must be 18 years of age or older.
Participant must have been previously diagnosed with unresectable or metastatic adenocarcinoma of the colon or rectum, which means the cancer cannot be removed by surgery and has spread to other parts of the body.
Participant's tumor must have specific genetic characteristics: wildtype KRAS, NRAS, BRAF and no evidence of ERBB2/HER2 amplification. This means the tumor does not have certain genetic mutations or changes.
Participant must have a type of disease that can be measured or evaluated according to specific medical guidelines.
Participant must have an ECOG Performance Status of 0 or 1, which means they are fully active or have some symptoms but can carry out light work.
Participant must have adequate organ and bone marrow function, which means their organs and bone marrow are working well enough to participate in the study.
Participant must have a tumor that can be biopsied and agree to have mandatory biopsies as part of the study. A biopsy is a procedure where a small sample of tissue is taken for testing.
Participants who are HIV-positive can join if they meet certain criteria.
A female participant of childbearing potential must have a negative pregnancy test before starting the study and agree to regular pregnancy tests during the study.
A female participant must either not be able to have children or use at least one highly effective method of contraception.
A female participant must agree not to donate eggs or freeze them for future use during the study and for 6 months after the last dose of study treatment.
A male participant must wear a condom during any activity that could result in pregnancy during the study and for 6 months after the last dose of study treatment. If the partner is a female who can have children, she must also use a highly effective method of contraception.
A male participant must agree not to donate sperm during the study and for 6 months after the last dose of study treatment.
Participant must sign an Informed Consent Form (ICF), indicating they understand the study and agree to participate.
Participant must be willing and able to follow the lifestyle restrictions required by the study.
Participant may have had another type of cancer in the past, as long as it does not interfere with the study.

Who cannot join the trial?

10 criteria

Patients who have a different type of cancer other than advanced or metastatic colorectal cancer cannot participate.
Patients who are currently receiving treatment with another experimental drug or therapy are not eligible.
Patients with a history of severe allergic reactions to similar medications are excluded.
Patients with uncontrolled medical conditions, such as high blood pressure or diabetes, that are not well-managed are not eligible.
Patients who are pregnant or breastfeeding cannot participate.
Patients with active infections, such as hepatitis or HIV, are excluded.
Patients who have had another cancer within the last 5 years, except for certain skin cancers, are not eligible.
Patients with significant heart problems, such as recent heart attacks or heart failure, are excluded.
Patients who have had major surgery within the last 4 weeks are not eligible.
Patients with a history of drug or alcohol abuse within the last year are excluded.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain
Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium

Trial locations

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Investigated drugs

Amivantamab is a medication being studied for its potential to treat advanced or metastatic colorectal cancer. It is used as a monotherapy, which means it is given by itself, to see how well it can fight cancer. Additionally, researchers are looking at how safe and effective it is when combined with standard chemotherapy treatments. The goal is to find out if adding amivantamab to the usual chemotherapy can help improve treatment outcomes for patients with this type of cancer.

What is already known about the treatment

Amivantamab – Amivantamab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating advanced or metastatic colorectal cancer, either alone or in combination with standard chemotherapy. The medication works by targeting specific proteins on cancer cells, helping the immune system to recognize and attack these cells. Amivantamab is classified as a monoclonal antibody, a type of drug designed to bind to specific targets in the body.

Investigated diseases

Advanced or Metastatic Colorectal Cancer – This disease is a form of cancer that originates in the colon or rectum and has progressed to an advanced stage, meaning it has spread beyond the original site to other parts of the body. The progression typically involves the cancer cells invading nearby tissues and organs, and potentially spreading to distant sites such as the liver, lungs, or lymph nodes. As the disease advances, it may cause symptoms like changes in bowel habits, abdominal pain, and weight loss. The spread of cancer cells occurs through the bloodstream or lymphatic system, leading to the formation of secondary tumors in other organs. The disease can affect the body's ability to absorb nutrients and may lead to complications such as bowel obstruction.