Amivantamab for Esophageal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether amivantamab, a targeted therapy, effectively and safely treats esophagogastric cancer with specific genetic changes known as EGFR or MET amplification. Researchers aim to determine if the drug can slow or stop cancer growth in patients who have already tried other treatments. Suitable candidates for this trial include those with esophagogastric cancer unresponsive to previous treatments and identified with these genetic changes. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing early access to potentially effective therapy.
Will I have to stop taking my current medications?
The trial requires that you have not received chemotherapy, targeted therapy, or biological therapy within 2 weeks before starting the study. If you are on these treatments, you may need to stop them before joining the trial.
Is there any evidence suggesting that amivantamab is likely to be safe for humans?
Research has shown that amivantamab has undergone safety testing in other studies. For example, one study found that serious side effects occurred in about 27.3% of patients, indicating that most patients experienced either mild side effects or none at all.
Amivantamab is also used to treat other cancers, such as non-small cell lung cancer, demonstrating prior human testing.
Overall, while some serious side effects can occur, most people experience milder ones. The advanced stage of this trial suggests the treatment is generally well-tolerated.12345Why do researchers think this study treatment might be promising?
Amivantamab is unique because it targets specific proteins on cancer cells, known as EGFR and MET, which are often involved in the growth of esophageal cancer. Unlike traditional chemotherapy that attacks rapidly dividing cells in general, amivantamab specifically binds to these proteins, potentially reducing damage to healthy cells and improving treatment precision. Researchers are excited about this approach because it may offer a more targeted therapy with the potential for better outcomes and fewer side effects compared to the current standard treatments like chemotherapy and radiation.
What evidence suggests that amivantamab might be an effective treatment for esophagogastric cancer?
Research has shown that amivantamab is a promising treatment for certain cancers, particularly those with EGFR and MET mutations. In a recent study, patients with these mutations responded well to the drug. Amivantamab targets and blocks these specific mutations, which often promote cancer growth. Previous studies have demonstrated that amivantamab can improve survival when combined with chemotherapy in lung cancer. This trial will assess its effectiveness for esophageal cancer patients with similar genetic markers.13678
Who Is on the Research Team?
Steven Maron, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with esophagogastric cancer that's spread or can't be removed surgically, who've tried at least one treatment before. They must have specific genetic changes (EGFR or MET amplification) and measurable disease. People with certain heart conditions, other active cancers, uncontrolled illnesses, recent blood clots, liver diseases including hepatitis B or C, lung conditions like ILD, mental health issues affecting trial participation are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive amivantamab intravenously weekly for the first cycle, and biweekly subsequently, continuing for up to 2 years or until disease progression or other discontinuation criteria are met
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Amivantamab
Amivantamab is already approved in United States, European Union for the following indications:
- Locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations
- Locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations
- Locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations
- Locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Janssen Pharmaceuticals
Industry Sponsor
Joaquin Duato
Janssen Pharmaceuticals
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Pharmaceuticals
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University