What side effects are associated with this type of intervention?

Common treatments for esophageal cancer, such as chemoradiotherapy, often result in side effects like fatigue, nausea, and increased liver function tests. Targeted therapies, particularly EGFR and MET inhibitors similar to amivantamab, can cause side effects including skin reactions, diarrhea, and infusion-related reactions. Immunotherapies, like pembrolizumab, may lead to immune-related adverse events such as colitis, pneumonitis, and endocrinopathies. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

FDA-approved treatments for esophageal cancer include several biologic therapies and immunotherapies. Pembrolizumab, an anti-PD-1 monoclonal antibody, has shown superiority over systemic chemotherapy in second-line therapy for advanced/metastatic esophageal squamous cell carcinoma (SCC) with high PD-L1 expression. Nivolumab is approved for advanced SCC after prior fluoropyrimidine- and platinum-based chemotherapy, regardless of PD-L1 expression status. While specific EGFR and MET inhibitors like amivantamab are still under investigation, these approvals highlight the growing role of targeted and immunotherapies in treating esophageal cancer.

What other types of research exist?

Promising alternatives to Amivantamab for esophageal cancer patients include: 1) Onartuzumab combined with mFOLFOX6, particularly for MET-positive tumors, as studied in the phase II YO28252 trial. 2) Pembrolizumab plus chemotherapy, which has shown significant improvement in overall survival and progression-free survival in the phase 3 KEYNOTE-590 study. 3) Ramucirumab plus paclitaxel, which has demonstrated efficacy in previously treated advanced gastric or gastroesophageal junction adenocarcinoma in the RAINBOW trial.

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Monoclonal Antibodies

Amivantamab for Esophageal Cancer

Q: What is the mechanism of action of this treatment?

Common treatments for esophageal cancer include chemotherapy, radiation therapy, and targeted molecular therapies. Chemotherapy agents like cisplatin and fluorouracil work by damaging the DNA of cancer cells, thereby inhibiting their ability to divide and grow. Radiation therapy uses high-energy rays to kill cancer cells or shrink tumors. Targeted therapies, such as EGFR and MET inhibitors like amivantamab, specifically target and block the activity of proteins involved in cancer cell growth and survival. These targeted treatments are particularly important for esophageal cancer patients with specific genetic mutations, as they can provide a more personalized and effective treatment approach with potentially fewer side effects compared to traditional chemotherapy.

Phase 2

Recruiting

Led By Steven Maron, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No prior receipt of an EGFR or MET inhibitor for esophagogastric cancer

Adequate organ function: Hemoglobin ≥9 g/dL, ANC ≥1.0 x 10^9 /L, Platelets ≥75 x 10^9 /L, AST and ALT ≤3 x ULN (≤5 x ULN for subjects with liver metastases), Total bilirubin ≤1.5 x ULN, Serum creatinine <1.5 x ULN or creatinine clearance >50 mL/min/1.73 m^2

Must not have

Uncontrolled inter-current illness, poorly controlled diabetes, ongoing or active infection, psychiatric illness/social situation limiting compliance

Recent cardiovascular events (myocardial infarction, unstable angina, stroke, etc.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a drug called amivantamab to see if it can treat esophagogastric cancer with specific genetic changes. The drug works by blocking proteins that help cancer cells grow. Researchers also want to know if the drug is safe and causes only mild side effects.

Who is the study for?

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.

What is being tested?

Researchers are testing amivantamab to see if it's effective and safe in treating esophagogastric cancer with EGFR or MET gene amplifications. Participants will have had previous treatments and their response to this new drug will be closely monitored.

What are the potential side effects?

While the exact side effects of amivantamab aren't listed here, similar drugs often cause reactions where the drug is injected into the body, skin rashes, fatigue, nausea and potential changes in liver function tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have not taken EGFR or MET inhibitors for my esophagogastric cancer.

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My blood counts and liver/kidney functions are within normal ranges.

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My cancer shows EGFR or MET amplification with a high copy number.

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My HER2+ cancer has worsened despite trastuzumab treatment.

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I have esophagogastric cancer that has spread or cannot be removed and have received at least one treatment.

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I am able to get out of my bed or chair and move around.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any major health issues that could interfere with the trial.

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I have not had recent heart attacks or strokes.

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I have severe heart failure or was recently hospitalized for it.

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I do not have any active or chronic liver diseases.

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I have lung disease or a lasting rash from immune therapy.

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I haven't fully recovered from a major surgery before starting treatment.

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I haven't had cancer treatment or recovered from its side effects in the last 2 weeks.

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I have had a recent blood clot in my lungs or veins.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

objective response rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: AmivantamabExperimental Treatment1 Intervention

Patients will receive amivantamab intravenously weekly for the first cycle, and biweekly subsequently at a dose of 1050mg (patients \<80kg) or 1400mg (patients ≥80kg). The initial dose will be administered over 2 days in split doses in order to mitigate the risk of infusion reactions. Therapy will continue for up to 2 years or until progression of disease, initiation of alternative cancer therapy, unacceptable toxicity, or other reason to discontinue treatment occurs-whichever comes first.

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for esophageal cancer include chemotherapy, radiation therapy, and targeted molecular therapies. Chemotherapy agents like cisplatin and fluorouracil work by damaging the DNA of cancer cells, thereby inhibiting their ability to divide and grow. Radiation therapy uses high-energy rays to kill cancer cells or shrink tumors. Targeted therapies, such as EGFR and MET inhibitors like amivantamab, specifically target and block the activity of proteins involved in cancer cell growth and survival. These targeted treatments are particularly important for esophageal cancer patients with specific genetic mutations, as they can provide a more personalized and effective treatment approach with potentially fewer side effects compared to traditional chemotherapy.

Targeted Molecular Therapies in the Treatment of Esophageal Adenocarcinoma, Are We There Yet?