Study on Amivantamab for Treating Esophagogastric Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60

ClinicalTrials ID:NCT05117931

This clinical trial is testing the effectiveness and safety of a new drug, amivantamab, for treating esophagogastric cancer that has specific genetic changes. The study aims to see if the drug can help control the cancer and if it causes few or mild side effects.

Patient Parameters

Program Overview

The purpose of this study is to find out if the drug amivantamab is a good treatment option for people with esophagogastric cancer that has certain genetic changes, specifically EGFR or MET amplifications. Researchers will also check if the drug is safe and causes only mild side effects in participants.

Eligibility Criteria

Inclusion Criteria

  • You or your legal representative must be willing to provide written consent to participate.
  • You have esophagogastric cancer that has spread or cannot be removed by surgery and have already received at least one treatment.
  • Your cancer must have specific genetic changes called EGFR or MET amplification, confirmed by specific tests.
  • You have not previously received drugs targeting EGFR or MET for this type of cancer, unless you have developed new genetic changes after treatment.
  • If your cancer is HER2 positive, it must have progressed after treatment with trastuzumab.
  • You must have measurable cancer based on specific medical criteria.
  • You are 18 years or older.
  • You have a performance status score of 0, 1, or 2, indicating you are fully active or have some restrictions but can still do light work.
  • Your organs are functioning well, as shown by specific blood tests.
  • Women who can become pregnant and men with partners who can become pregnant must agree to use effective birth control methods.

Exclusion Criteria

  • You have had chemotherapy or other cancer treatments within the last two weeks and have not recovered from side effects.
  • You have had major surgery recently and have not fully recovered.
  • You have another active cancer that needs treatment, except for certain skin or cervical cancers.
  • You have active hepatitis B or C infections.
  • You have other active or chronic liver diseases.
  • You have uncontrolled health issues, such as poorly managed diabetes or ongoing infections.
  • You have had blood clots in the lungs or deep veins within the last month.
  • You have had a heart attack, stroke, or similar heart issues within the last six months.
  • You have severe heart failure or have been hospitalized for heart failure recently.
  • You have lung diseases that require ongoing treatment and have not resolved recently.
  • You have unresolved skin rashes from previous cancer treatments.
  • You have mental health or substance abuse issues that would interfere with the study.
  • You are pregnant, breastfeeding, or planning to have children during the study and for six months after.
  • You are a prisoner or are being held involuntarily.

Locations

FACILITYZIPCITYSTATE
University of California, Irvine92697IrvineCalifornia
Massachusetts General Hospital (Data Collection Only)02114BostonMassachusetts
Memorial Sloan Kettering Basking Ridge (Limited protocol activities)07920Basking RidgeNew Jersey
Memorial Sloan Kettering Monmouth (Limited protocol activities)07748MiddletownNew Jersey
Memorial Sloan Kettering Bergen (Limited Protocol Activities)07645MontvaleNew Jersey
Memorial Sloan Kettering Commack (Limited Protocol Activities)11725CommackNew York
Memorial Sloan Kettering Westchester (Limited Protocol Activities)10604HarrisonNew York
Memorial Sloan Kettering Cancer Center (All Protocol Activities)10065New YorkNew York
Memorial Sloan Kettering Nassau (Limited protocol activities)11553Rockville CentreNew York

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